22 Regulatory Affairs jobs in Saudi Arabia

# 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

Main Responsibilities

Required experience and qualifications

Skills and Competencies

Roche is an Equal Opportunity Employer.

Sub Category

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.

Location: KSA, Riyadh

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.

• 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

• 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

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

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

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

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

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.

  
  

RA Specialist will fulfill the local regulatory activities to maintain & keep the RA portfolio compliant for KSA ( 70 % ) and rest of ME markets ( 30%) . He / she will support RA manager on operational RA submissions to allow the RA managers in UAE & KSA to focus on critical projects Relfydess & Nemluvio . In addition , RA manager in KSA needs to focus on enhancing external engagement with Health authority & local trade association that is identified as a major gap currently. RA Specialist will ensure business continuity and serve as a back up for RA manager in KSA for RA in addition to serving as a back up for QA & PV , considering that RA , QA & PV are mandatory functions to be always available on site .Provide strategic and operational RA support for Saudi to ensure on time renewal, maintenance , variations of existing & new products for IA, TD, DS including mandatory regulatory. It is critical to maintain momentum 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 & rest of ME markets

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. With the LE set up in Saudi the responsibilities & accountability of RA manager in front of Saudi HA ( SFDA ) have increased requiring more time & focus from RA manager to engage with external stakeholders & ensure compliance at all time for all regulated TD,IA,DS portfolio. RA specialist is critical to ensure compliance to ongoing RA activities , serve as back up for RA / QA/PV and allow RA to focus on critical submissions ongoing & to be made for Relfydess & Nemluvio to enable timely registrations . 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

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 with Computer based information systems, and new

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.

Company Industry

• Pharma
• Biotech
• Clinical Research

Department / Functional Area

• Administration

Keywords

• Regulatory Affairs Specialist KSA

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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

Job Description

Bring energy, knowledge, innovation to carry out the following:

(may not be limited to):

• Ensure timely preparation, submission and appropriate follow-up of new Marketing Authorization applications to the local authorities.
• Ensure maintenance of assigned, authorized products through timely submission of variations, renewal applications, and supplemental marketing authorizations.
• For assigned products ensures high quality labelling translation andartwork management.
• Supports the agency interactions to ensure a seamless submission, assessment, and quick approval of the CTAs, according to the new regulations, in cooperation with other internal stakeholders.
• Stay updated on relevant EU and local regulations and guidelines.
• Collects relevant publicly available regulatory information (regulatory intelligence) and keeps relevant persons appropriately informed.
• Maintains a positive relationship with internal and external regulatory contacts on sub-regional, regional and global level, our Manufacturing Division, EUQPPV and GSC&PV are the main contact points within the company. External contacts are regulatory authorities, as well as other key players in the regulatory environment.

What skills you will need:

In order to excel in this role, you will more than likely have:

• Must hold a degree in pharmacy or otherlife scienceor equivalent. An approx. minimum of 1-2 years’ experience in the pharmaceutical Industry is preferable, in a regulatory, medical or laboratory position.
• Ability to communicate well verbally and in writing, good organizational and planning skills, a meticulous attention to detail and be flexible enough to successfully handle conflicting time pressures and a large volume of work
• A sound appreciation of the interactions and relationships with other groups internally, a client-oriented approach and work according to the company leadership vision

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills:

Preferred Skills:

Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID: R357103