22 Regulatory Submissions jobs in Saudi Arabia

Arthur Lawrence is urgently looking for a Senior Regulatory Compliance Manager for a client in Riyadh, KSA.

• Kindly review the Job requirements below.

Your immediate application will enable us to place you successfully.

Must-Have : 10+ years of experience in a regulatory compliance, legal, or risk management role within financial services or fintech.

Strong knowledge of Saudi financial regulatory frameworks (SAMA), particularly Consumer Protection regulations.

Experience working closely with product, engineering, and legal teams in a fast-paced, agile environment.

Proven ability to interpret regulatory requirements and design practical compliance solutions.

Excellent communication and stakeholder management skills, including experience interfacing with regulators or banking partners.

Ability to work independently, make sound decisions, and manage competing priorities.

Nice to have : Bachelors degree in Business Administration, Law, Finance, or Accounting Certifications in CRCM, CAMS, CRCMP, or PMP preferred About Us : Arthur Lawrence is a management and technology consulting firm providing enterprise-wide business transformation and business applications implementation services.

Our in-depth technical knowledge and broad experience of working with world-class companies enables organizations to leverage our capabilities in developing winning strategies and cost-effective solutions.

We are an UN Women Empowerment Principal Signatory and are certified from National Minority Supplier Development Council.

Acknowledgements from Industry Peers : Winner of Entrepreneur 360 Award (2019).

IAOP Award; Ranked in top 100 internationally.

Arthur Lawrence ranked within the Inc 5000 twice in 2016 and 2017 as one of the fastest.

Growing companies of America.

Named one of the top ten fastest growing businesses in Houston in 2016.

Ranked 25th in the HBJ s Fast 100 Private Companies Award in 2017.

Our Seven Pillars : We rely on the seven core values that we believe enable us to deliver quality for our consultants and clients : Education, Integrity, Value Creation, Collaboration, Best Client, Best People and Stewardship Through strict adherence to these core values, we have achieved success beyond all documented forecasts and anticipation.

#J-18808-Ljbffr

Company Description

About Veolia

Veolia aims to be the benchmark company for ecological transformation . Our mission to " Resource the world " demonstrates the unwavering commitment of our 220,000 employees to creating a positive impact for our planet.

By joining Veolia Water Technologies, not only will you become a Resourcer, but you will also take part in providing complete solutions for water treatment. By innovating in key areas such as sustainable development, resource and product recovery, we want to offer water related solutions suited for every application.

At Veolia Water Technologies, Saudi Arabia , we are committed to empowering our employees, to make their own decisions and to make a real difference.

Become a player in ecological transformation by joining us!

Job Description

The Product Regulatory Compliance Specialist ensures our chemical products meet all regulatory requirements, particularly in the Middle East markets. This role will manage product compliance, documentation, and regulatory affairs while supporting business growth through effective compliance strategies.

Main tasks and responsibilities include but are not limited to the following:

Essential Responsibilities:

• Ensuring manufactured products meet all regulatory standards and other certification standards (NSF etc)
• Monitoring compliance with chemical regulations (REACH, GHS, TSCA, CLP, etc.)
• Managing product safety data sheets (SDS) and other applicable regulatory documentation.
• Conducting product compliance audits and assessments.
• Reviewing raw material compliance and supplier documentation.
• Maintaining product registrations and certifications
• Collaborate with quality control and manufacturing teams.
• Creating, designing, and verifying product labelling and packaging compliance.
• Supporting customer compliance inquiries and requirements.
• Tracking regulatory changes affecting product specifications.
• Collaborating with manufacturing teams to ensure compliance in production.
• Maintaining compliance databases and documentation systems.
• Supporting new product development with compliance guidance.
• Coordinating with regulatory agencies and certification bodies.
• Developing and implementing compliance procedures.
• Training staff on compliance requirements.
• Managing chemical inventory compliance.
• Supporting safety and environmental compliance initiatives.
• Participate or lead assigned projects.

Desired Characteristics:

• Strong attention to detail and analytical skills
• Excellent project management capabilities
• Superior communication and interpersonal abilities
• Problem-solving mindset
• Ability to work independently and in teams.
• Strong organizational and documentation skills
• Adaptable to changing regulatory requirements.
• Customer-focused approach
• Ability to manage multiple priorities.
• Proactive and results-oriented attitude

Qualifications

Job specifications

Qualifications

• Bachelor's degree in chemistry or chemical engineering.
• Valid GCC driver's license

Experience

• Minimum 3 years' experience in chemical regulatory compliance.
• Demonstrated experience with GCC chemical regulations and transport requirements.
• Knowledge of international chemical regulations (REACH, GHS, etc.).
• Strong understanding of chemical safety and hazard classification.
• Knowledgeable and possess training certificate and experience related to Dangerous Goods transport regulations (IMDG, IATA and ADR).
• Proficiency in both English and Arabic.
• Experience with compliance management systems.

Specific training

• Preferred candidates will have IATA, IMDG and ADR training.

Additional Information

QHSE Commitments:

• Implementing the QHSE policies and ISO Procedures.
• Follow the always safe rules and coach your colleagues on the same
• Follow the road traffic rules while driving to and from home to work (fasten seat belt, maintain speed limits, never use mobile / eat/drink/smoke while driving, drive in a fit condition).
• Being responsible towards Veolia's specific sustainable development commitments.
• Ensure to read the safety moments / Alerts / other information shared by the HSE Team.
• Before visiting any site, factory, and/or warehouse, make sure to inform the safety team to get the right induction and prepare LMRA and the needed PPE.
• Always maintain office safety such as keeping your files/papers in the correct place, keeping the drawers closed after use, arranging the electrical cables secured to avoid slips & trips, reporting any lost connections or damaged electrical components, and ensuring your office is clean and tidy
• Report to HR/HSE if you are facing stress, fatigue, any form of harassment, or bullying at the workplace.

Veolia Code of Conduct

• Comply with applicable ethics and legislation referred to in Veolia Code of Conduct policy, particularly in the fight against corruption and influence peddling.

As an inclusive company, Veolia is committed to diversity and gives equal consideration to all applications, without discrimination.

Arthur Lawrence is urgently looking for a Senior Regulatory Compliance Manager for a client in Riyadh, KSA.

• Kindly review the Job requirements below.

Your immediate application will enable us to place you successfully.

Must-Have : 10+ years of experience in a regulatory compliance, legal, or risk management role within financial services or fintech.

Strong knowledge of Saudi financial regulatory frameworks (SAMA), particularly Consumer Protection regulations.

Experience working closely with product, engineering, and legal teams in a fast-paced, agile environment.

Proven ability to interpret regulatory requirements and design practical compliance solutions.

Excellent communication and stakeholder management skills, including experience interfacing with regulators or banking partners.

Ability to work independently, make sound decisions, and manage competing priorities.

Nice to have : Bachelors degree in Business Administration, Law, Finance, or Accounting Certifications in CRCM, CAMS, CRCMP, or PMP preferred About Us : Arthur Lawrence is a management and technology consulting firm providing enterprise-wide business transformation and business applications implementation services.

Our in-depth technical knowledge and broad experience of working with world-class companies enables organizations to leverage our capabilities in developing winning strategies and cost-effective solutions.

We are an UN Women Empowerment Principal Signatory and are certified from National Minority Supplier Development Council.

Acknowledgements from Industry Peers : Winner of Entrepreneur 360 Award (2019).

IAOP Award; Ranked in top 100 internationally.

Arthur Lawrence ranked within the Inc 5000 twice in 2016 and 2017 as one of the fastest.

Growing companies of America.

Named one of the top ten fastest growing businesses in Houston in 2016.

Ranked 25th in the HBJ s Fast 100 Private Companies Award in 2017.

Our Seven Pillars : We rely on the seven core values that we believe enable us to deliver quality for our consultants and clients : Education, Integrity, Value Creation, Collaboration, Best Client, Best People and Stewardship Through strict adherence to these core values, we have achieved success beyond all documented forecasts and anticipation.

#J-18808-Ljbffr

Corporate Senior Manager Regulatory Compliance leads a small group of compliance professionals and assigned to handle Wholesale Banking Group (Corporate Banking Group, Global Transaction Services, Front Office Support), Global Market Group & Risk Management Group in terms of Compliance responsibilities. This role works for strong relationship management with assigned functions and responsible for advising, monitoring, reporting and escalating on compliance matters. The role is typically for the relevant content expert who is handling given area of responsibility.
- This role is responsible for working for a strong compliance culture. This role is a senior professional with significant compliance and people management capabilities. This position reports directly to the Head of Regulatory Compliance.
- Supporting & assisting Compliance management in Compliance risk management
- Close coordination with all assigned functions and ensuring full support on Compliance matters
- Ensuring a strong mechanism of monitoring, follow up, reporting and escalation is in place in terms of adequate implementation of regulatory directives.
- Reviewing new products & services, analyzing assigned functions requests and preparing compliance opinion. Ensuing complete record of reviews and compliance opinion is maintained
- Participates in the production, documentation and approval of the Compliance monitoring checklists, plans and standard reports
- Ensures that monitoring & reporting activities are undertaken effectively and ensures all applicable reports are submitted as complete and accurate in a timely manner
- Developing and maintaining comprehensive compliance procedures to avoid any misunderstanding for the staff members involved in concerned activities
- Supports the Manager on ad-hoc projects including promoting compliance culture within the BSF, inspection visits (internal and external) to the bank and to fulfil any compliance-reporting requirement from the senior management.
- Provides direction, guidance to assigned team on delivering the department’s responsibilities
- Ensures that all BSF standards and requirements are met by each member of the department.

**Detecting and Combating Fraud**:

- Create an ethical environment within the concerned Group / Division and behave with integrity by setting an example to all other employees.
- Follow proper control procedures / measures and refrain from violating rules and procedures by abusing your authority. Ensure all staff under your management understand, document and record their responsibility in detecting and combating fraud.
- Provide the necessary guidance and support for employees regarding the notification of suspected fraud.
- Fully cooperate with AFMD regarding implementing recommendations and preventive measures.
- Read, understand and comply with AFMD Policy and Procedures.
- Commit to report fraud cases or suspected behavior as per the Whistle Blowing and Code of Conduct &and Professionals Ethics Policies.
- To have the highest standards of ethics, commitment and honesty as per the Code of Conduct and Professionals Ethics.

**Operational Risk**:

- Ensuring group-wide adherence to the Operational Risk Management Policy, including the timely reporting of operational risk incidents and related cooperation to analyze and bridge internal control gaps.

**Compliance**:

- Comply with all applicable laws and regulations and report any violations or financial crimes, including money laundering and terrorist financing.

**المهارات**:

- Bachelor Degree in Finance or Business
- 8-10 years banking experience in related field
- 5-7 years within Compliance/Audit areas of the bank
- Must be able to communicate both in Arabic and English
- Sound knowledge on KSA regulatory environment
- High ethical standards
- Experience in managing staff
- Analytical skills
- Ability to get on with people at all levels
- Strong ability to work under pressure and to handle large workloads;
- Excellent organizational and multi-tasking skills
- Demonstrated commitment to quality customer service
- Strong verbal and written interpersonal and communication skills
- Ability to deal effectively with customers, peers and management at all levels;
- Excellent problem-solving skills and decision-making ability

# Regulatory Affairs Manager
This job is available in 2 locations
Category
Regulatory Affairs
Job Id
202507-116668
JOB DESCRIPTION
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.
#
# The Position

The Opportunity

Doing now what patients need next. This is the purpose we follow at Roche to get better outcomes for our patients faster.
The role of Regulatory Affairs Manager is key in achieving this purpose through
developing regulatory strategies, managing regulatory projects and performing
associated activities to ensure the rapid and optimal registration for new Roche
Pharma products and indications in Iraq.
Regulatory Affairs Manager works closely with health authorities in Iraq in
coordination with Distributor to ensure ongoing regulatory compliance and
maintain existing registrations throughout a product’s lifecycle.
He/she plays an important role in delivering the key function of achieving timely
approval of and the broadest use of products for Roche in Iraq.

Main Responsibilities

- Set the regulatory strategy of the Iraq market and drive local implementation in coordination with relevant internal and external stakeholders (like the distributor)
- Shape the regulatory environment by participating in industry associations on regulatory policy and regulations. Contribute to global regulatory strategies, considering local regulation and patients’ needs.
- Lead and develop risk-based regulatory strategies and workplans for all products across the Affiliate to accelerate access in alignment with global.
- Ensure regulatory inspection-readiness for the Affiliate, including leading or participating in internal/external regulatory audits. Ensure all Affiliate regulatory activities comply with Roche global standards and local regulations as well as regulatory compliance for product released to market according to marketing authorizations.
- Deliver on time the required regulatory information to all relevant colleagues who are responsible for particular products, and Keeps all relevant stakeholders like the pharmacovigilance personnel, Medical Director updated on relevant regulatory information
- Maintenance and regularly update local registration database for all Roche medicinal products registered in Iraq.
- Perform risk assessments related to regulatory compliance and product safety. Develop action plans to mitigate potential risks.

Required experience and qualifications

- University degree in medicine, pharmacy or other life sciences. Postgraduate degree in a related field is a privilege.
- 5 or more years of previous regulatory experience in the pharmaceutical, biotechnology, or related industry.
- Previous regulatory experience in Iraq is a plus.
- Expert knowledge of the industry’s Codes of Conduct and other relevant standards and guidelines.
- Fluency in Arabic and English oral and written.

Skills and Competencies

- Highly organized, with ability to prioritize own tasks as well as those of others.
-Strong written and verbal communication skills: communicates in a concise and clear manner that supports expeditious and effective decision-making.
- Strategic agility.
- Strong influencing skills: can influence without authority and has proven experience building and cultivating relationships with key partners/stakeholders.
- Strong negotiation skills: can effectively drive discussions and decisions toward desired outcomes.
- Ability to work in a matrix model, across geographies and organization at all levels. Experience of resolving complex issues in a matrix organization
# Who we are
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.

Sub Category

General Regulatory Affairs
Location
Salmiya, Kuwait
Category
Customer Support
Location
Riyadh, Riyadh, Saudi Arabia
Category
Sales & Marketing
Location
Riyadh, Riyadh, Saudi Arabia
Category
Business Services & Support
Location
Jeddah, Makkah, Saudi Arabia
Category
Vocational & Development Programs
Location
Istanbul, İstanbul, Türkiye
Category
Audit & Compliance
Interview Experience
Positive 69%
Neutral 15%
Negative 16% #J-18808-Ljbffr

# Regulatory Affairs Manager
This job is available in 2 locations
Category
Regulatory Affairs
Job Id
68
JOB DESCRIPTION
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

The Opportunity

Doing now what patients need next. This is the purpose we follow at Roche to get better outcomes for our patients faster.
The role of Regulatory Affairs Manager is key in achieving this purpose through
developing regulatory strategies, managing regulatory projects and performing
associated activities to ensure the rapid and optimal registration for new Roche
Pharma products and indications in Iraq.
Regulatory Affairs Manager works closely with health authorities in Iraq in
coordination with Distributor to ensure ongoing regulatory compliance and
maintain existing registrations throughout a product's lifecycle.
He/she plays an important role in delivering the key function of achieving timely
approval of and the broadest use of products for Roche in Iraq.

Main Responsibilities

- Set the regulatory strategy of the Iraq market and drive local implementation in coordination with relevant internal and external stakeholders (like the distributor)
- Shape the regulatory environment by participating in industry associations on regulatory policy and regulations. Contribute to global regulatory strategies, considering local regulation and patients' needs.
- Lead and develop risk-based regulatory strategies and workplans for all products across the Affiliate to accelerate access in alignment with global.
- Ensure regulatory inspection-readiness for the Affiliate, including leading or participating in internal/external regulatory audits. Ensure all Affiliate regulatory activities comply with Roche global standards and local regulations as well as regulatory compliance for product released to market according to marketing authorizations.
- Deliver on time the required regulatory information to all relevant colleagues who are responsible for particular products, and Keeps all relevant stakeholders like the pharmacovigilance personnel, Medical Director updated on relevant regulatory information
- Maintenance and regularly update local registration database for all Roche medicinal products registered in Iraq.
- Perform risk assessments related to regulatory compliance and product safety. Develop action plans to mitigate potential risks.

Required experience and qualifications

- University degree in medicine, pharmacy or other life sciences. Postgraduate degree in a related field is a privilege.
- 5 or more years of previous regulatory experience in the pharmaceutical, biotechnology, or related industry.
- Previous regulatory experience in Iraq is a plus.
- Expert knowledge of the industry's Codes of Conduct and other relevant standards and guidelines.
- Fluency in Arabic and English oral and written.

Skills and Competencies

- Highly organized, with ability to prioritize own tasks as well as those of others.
-Strong written and verbal communication skills: communicates in a concise and clear manner that supports expeditious and effective decision-making.
- Strategic agility.
- Strong influencing skills: can influence without authority and has proven experience building and cultivating relationships with key partners/stakeholders.
- Strong negotiation skills: can effectively drive discussions and decisions toward desired outcomes.
- Ability to work in a matrix model, across geographies and organization at all levels. Experience of resolving complex issues in a matrix organization
# Who we are
A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let's build a healthier future, together.

Roche is an Equal Opportunity Employer.

Sub Category

General Regulatory Affairs
Location
Salmiya, Kuwait
Category
Customer Support
Location
Riyadh, Riyadh, Saudi Arabia
Category
Sales & Marketing
Location
Riyadh, Riyadh, Saudi Arabia
Category
Business Services & Support
Location
Jeddah, Makkah, Saudi Arabia
Category
Vocational & Development Programs
Location
Istanbul, İstanbul, Türkiye
Category
Audit & Compliance
Interview Experience
Positive 69%
Neutral 15%
Negative 16%

Join to apply for the Regulatory Affairs Specialist KSA role at Galderma .

Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare, and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand the skin, we are shaping our lives, and we are advancing dermatology for every skin story.

We look for people who focus on results, embrace learning, and bring positive energy. They must combine initiative with teamwork and collaboration. Above all, they must be passionate about making a meaningful impact for consumers, patients, and healthcare professionals. We aim to empower employees and promote personal growth while meeting business needs now and in the future. We embrace diversity and respect the dignity, privacy, and personal rights of every employee.

At Galderma, we are committed to becoming the leading dermatology company in the world. Join us to gain new experiences and create an impact.

Regulatory Affairs Specialist KSA

Location: KSA, Riyadh

Job Description

The RA Specialist will manage local regulatory activities to ensure compliance for KSA (70%) and UAE (30%). They will support the RA manager in operational submissions, ensure compliance with all RA and SO responsibilities, and be prepared for audits by HA. The role includes ensuring business continuity, serving as a backup for the RA manager in KSA, and supporting QA and PV functions. The specialist will provide strategic and operational support for product renewals, maintenance, and variations, maintaining momentum to comply with SFDA guidelines.

Responsibilities

• Manage registration processes for new products and amendments
• Develop and execute registration strategies in collaboration with Global and local RA teams
• Ensure compliance with evolving regulatory frameworks in KSA and UAE
• Maintain existing product licenses
• Support high-quality and timely submissions; enhance regulatory intelligence; maintain databases for record retention and submission tracking
• Communicate application progress to stakeholders
• Manage regulatory files and documentation; support process improvements and internalize outsourced activities

Minimum Requirements

• Pharmacist or Pharmaceutical Sciences degree
• Saudi MOH license and Saudi nationality
• 4-5 years' experience in regulatory affairs related to medicinal products and medical devices in Saudi Arabia & UAE
• Strong understanding of the pharmaceutical industry and SFDA connections preferred
• Knowledge of Pharmacovigilance and quality systems preferred
• Computer literacy and familiarity with electronic documentation systems
• Fluent in English and Arabic, both written and verbal

What We Offer

• Inclusive work environment embracing diversity
• Competitive compensation, bonus, and benefits
• Growth opportunities with ownership from day one

Next Steps

• Apply with an English CV
• If shortlisted, participate in virtual interviews with recruiter, hiring manager, and team panels

Additional Information

• Seniority level: Mid-Senior
• Employment type: Full-time
• Job function: Legal
• Industry: Pharmaceutical Manufacturing

#J-18808-Ljbffr

At Julphar, we are on a journey of culture transformation & our mission is to provide a better quality of life for the entire family by delivering best in class solutions and real value with compassion and professionalism.

Our core values: Respect, Collaboration, innovation, Integrity and Compassion - Combined with a focus on diversity, inclusion, and equal opportunities - are key drivers in our aim to make a positive impact on the lives of the patients we serve, enable Talents , create a healthy work environment, and accomplish our goals through world-class research and with the compassion and commitment of our employees.

Designation: Regulatory Affair Senior Officer

Department: Scientific Office / Riyadh K.S.A

Summary of Responsibilities:

• 
  

  To facilitate all regulatory activities between Julphar headquarter and the local authority.

  
  


• 
  

  To review and coordinate a database for regulatory activities and documentation.

  
  


• 
  

  Provide input to strategic decisions affecting the functional areas of responsibility.

  
  

Detailed Job Responsibilities:

• 
  

  Liaise with RA-HQ for annual regulatory activity plans (new registrations, renewals, post-approval activities).

  
  


• 
  

  Acknowledge receipt of regulatory files from RA-HQ and provide expected submission dates to Health Authority (HA).

  
  


• 
  

  Review regulatory files before HA submission to ensure compliance with guidelines, scientific accuracy, clarity, and to expedite submission.

  
  


• 
  

  Maintain effective relationships with health authorities, liaise, and negotiate when necessary.

  
  


• 
  

  Provide acknowledgment receipt to RA-HQ upon submission of each application.

  
  


• 
  

  Follow up regularly with regulatory authorities on submitted applications.

  
  


• 
  

  Receive authority queries, filter fulfilled requirements, and forward to RA-HQ within 2 working days.

  
  


• 
  

  Collaborate with RA-HQ to ensure timely compliance with authority timelines and coordinate with HA for timeline extensions if needed.

  
  


• 
  

  Review and confirm HA registration certificates/decisions for discrepancies and share approval decisions with RA-HQ within 3 working days.

  
  


• 
  

  Review the master regulatory tracker regularly and communicate updates to RA-HQ within 2 days.

  
  


• 
  

  Interpret authority rules and changes, and update RA-HQ with circulars, new decisions, and guideline updates within 3 working days.

  
  


• 
  

  Report any change in product pricing to RA-HQ immediately.

  
  


• 
  

  Provide a monthly report for all regulatory transactions, including submissions, approvals, and query handling.

  
  


• 
  

  Be proactive in the dynamic regulatory environment of the region/countries, especially regarding guidelines and pricing, and provide necessary feedback.

  
  

Technical Qualifications:

• 
  

  Bachelor of Pharmacy.

  
  

Requirement (Soft Skills & Attributes):

• 
  

  Computer skills (Ms Office, Google Drive, spreadsheet, and database).

  
  


• 
  

  Planning (Assessment, analysis, problem solving, collaboration and communication skills).

  
  


• 
  

  Management skills (prioritization, task separation and multiple task handling).

  
  


• 
  

  Good communication and presentation skills.

  
  


• 
  

  Maintaining a comprehensive knowledge of local authority regulation and sufficient knowledge of global regulatory legislation and guidelines

  
  
  

We value people from different backgrounds. Could this be your story? Apply today or visit read more about us and the journey of Julphar

#J-18808-Ljbffr

Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin, we are in shapes our lives, we are advancing dermatology for every skin story.

We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.

At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.

Regulatory Affairs Specialist KSA

KSA, Riyadh

Job Description

RA Specialist will fulfill the local regulatory activities to maintain & keep the RA portfolio compliant for KSA ( 70 % ) and UAE ( 30%) . He / she will support RA manager on operational RA submissions , support RA manager on to ensure compliance of all RA & SO repsonsibilites at all times and to be ready for audits anytime by HA . RA Specialist will ensure business continuity , and serve as a back up for RA manager in KSA for RA in additon to serving as a back up for QA & PV , considering that RA , QA & PV are mandatory functions to be always available on site including during vacations necessitating the need to have at least 1 RA/ QA/ PV to be available on site all the time .Provide strategic and operational RA support for Saudi to ensure on time renewal, maintenance , variations of existing & new prodcuts for Prescription, Injectible aeshetics / Medical devices, Cosmetics . It is critical to maintain mometum to ensure compliance to constantly evolving SFDA guidelines

Duties & Responsibilities

• Manage the entire registration process in ensuring approvals of new products and amendments to products

  
  

• Develop and execute registration strategy in close partnership with Global RA & local RA manager

  
  

• Stay abreast of - and ensure compliance with - the continuously evolving (complex & country specific) regulatory framework in KSA & UAE

  
  

• Ensure compliance with, and maintenance of, existing product licenses.

  
  

• Ensure high quality and timely submissions, support in enhancing regulatory intelligence & create & maintain database for simplifying local RA processes of record retention & regulatory submission tracking

  
  

• Ensure that progress of applications and changes to registered details are communicated to local and global stakeholders, as appropriate

  
  

• Manage in-house regulatory files, documentation and Corporate electronic databases. RA specialist is critical to ensure compliance to ongoing RA activities , serve as back up for RA / QA/PV . RA specialist will also support projects that need improvement in process enhancement & simplification tools for all ME markets , such as tracking tools , data management & also internalize some of the RA activities that are currently outsourced such as eCTD preparation in a phased manner

  
  

Minimum Requirements

• Pharmacist degree/Bachelor degree in Pharmaceutical sciences.

  
  

• Saudi Arabia national and MOH licensed pharmacist

  
  

• Minimum 4-5 years’ experience in a similar Regulatory affairs role in the field of prescription medicinal products and medical devices in Saudi Arabia & UAE

  
  

• In-depth understanding of the pharmaceutical industry within Saudi Arabia, and strong connections with SFDA will be preferred

  
  

• Quality experience & fair knowledge of Pharmacovigilance preferred.

  
  

• Computer literate, familiar wit• Manage the entire registration process in ensuring approvals of new products and amendments to products

  
  

• Electronic documentation systems.

  
  

• Fluency in written and verbal English and Arabic

  
  

What we offer in return

• You will be working for an organization that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base.

  
  

• You will receive a competitive compensation package with bonus structure and extended benefit package.

  
  

• You will be joining a growing company that believes in ownership from day one where everyone is empowered to grow and to take accountability.

  
  

Next Step

• Please apply with an English language CV.

  
  

• If your profile is a match, we will invite you for a first virtual conversation with the recruiter.

  
  

• The next step is a virtual conversation with the hiring manager.

  
  

• The final step is a panel conversation with the extended team.

  
  

#J-18808-Ljbffr