43 Clinical Affairs jobs in Saudi Arabia

Be the bridge between innovation and patient safety—As a Regulatory Affairs Specialist in Saudi Arabia’s dynamic healthcare landscape, you’ll play a pivotal role in shaping the future of medicine. From ensuring compliance with SFDA regulations to accelerating access to life-saving therapies, your expertise drives both public health and industry growth. Join a mission where precision meets purpose, and every regulation you navigate brings better care to millions.

Major Accountabilities

• New Product Registrations – With supervision, evaluate, and prepare drug registration applications in a timely manner and follow through the application during the evaluation phase to achieve a favorable outcome
• Maintenance of registered products – With supervision, maintain registration of currently approved products (initiation and preparation of variation/ and renewal applications as per the plan communicated from the DRA manager/Head).
• Coordinate with DRA manager/head to ensure correct and speedy implementation / consignments as per the approved applications (variation/ renewal/ site transfer/ site registration/leaflet update).
• Maintain, with supervision, the internal DRA database accurate and updated: Dragon/DASA
• Relationships within and outside the company - Develop and maintain good working relationships with other Novartis departments both locally and with Head Office and with third-party vendors.
• With Supervision, Review PPMS and ensure AQWA Launch request are prepared and launched on time.
• With Supervision, ensure full support to Global regulatory compliance initiatives in Saudi.
• Pharmacy or related science degree.
• Minimum 1 year of RA Experience in reputable pharmaceutical company.
• Experience handling a portfolio/product and dealing with stakeholder such as SFDA and governmental agency.
• Must be Saudi national.

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Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

The Regulatory Affairs Specialist plays a crucial role in ensuring that medical and healthcare equipment complies with all regulations and standards set by governmental and international bodies. This position involves a deep understanding of the regulatory landscape and the ability to navigate complex compliance requirements. The specialist will be responsible for preparing and submitting regulatory documents, managing product registrations, and ensuring that all products meet safety and efficacy standards before they reach the market. This role is essential for maintaining the company's reputation and ensuring the safety of healthcare products.

Responsibilities:

1. Prepare and submit regulatory documents to ensure compliance with local and international regulations.
2. Manage product registrations and maintain up-to-date records of regulatory submissions.
3. Conduct thorough reviews of product labeling and promotional materials for compliance.
4. Collaborate with cross-functional teams to ensure that product development aligns with regulatory requirements.
5. Monitor changes in regulations and assess their impact on the company's products.
6. Provide guidance and training to internal teams on regulatory requirements and best practices.
7. Prepare for and participate in regulatory inspections and audits.
8. Develop and maintain relationships with regulatory agencies.
9. Assist in the preparation of responses to regulatory inquiries and issues.
10. Support the development of regulatory strategies for new products and market expansions.

Preferred Candidate:

1. Strong analytical and problem-solving skills.
2. Excellent communication and interpersonal abilities.
3. Detail-oriented with a high level of accuracy.
4. Ability to work independently and manage multiple projects simultaneously.
5. Proficient in regulatory documentation and submission processes.
6. Experience in the medical device or healthcare industry.
7. Knowledge of quality management systems and standards.
8. Ability to adapt to changing regulations and industry trends.
9. Strong organizational skills and time management.
10. Commitment to continuous professional development in regulatory affairs.

Skills

• In-depth knowledge of regulatory requirements for medical devices.
• Strong understanding of quality management systems (QMS) ISO 13485.
• Proficient in regulatory submission software and tools.
• Excellent written and verbal communication skills.
• Ability to interpret complex regulations and guidelines.
• Strong project management skills.
• Familiarity with clinical trial processes and documentation.
• Ability to work collaboratively in a team environment.

Specialist, Regulatory Affairs page is loadedSpecialist, Regulatory Affairs Apply locations SA Riyadh time type Full time posted on Posted 8 Days Ago job requisition id JR1999 ARA-P1-10

Responsible for dossier compilation and submission • Responsible for ensuring compliant life cycle management in compliance with market regulations • Manage local Labeling and AWs creation and submission • Maintain the regulatory processes within the department, including assist with the development and implementation of regulatory procedures and SOP, • Manage Communication with regulatory agencies or related interface

Additional Job Description:

Primary Location:

Job Posting Date:

Job Type:

Mundipharma is a global healthcare company with a presence across Africa, Asia Pacific, Canada, Europe, Latin America, and the Middle East.

Mundipharma is dedicated to bringing innovative treatments to patients in the areas of Pain Management, Infectious Disease and Consumer Healthcare as well as other severe and debilitating disease areas. Our guiding principles, centered around Integrity and Patient-Centricity, are at the heart of everything we do.

For more information about Mundipharma's guiding principles and commitment to diversity and inclusion visit:

Be the bridge between innovation and patient safety-As a Regulatory Affairs Specialist in Saudi Arabia's dynamic healthcare landscape, you'll play a pivotal role in shaping the future of medicine. From ensuring compliance with SFDA regulations to accelerating access to life-saving therapies, your expertise drives both public health and industry growth. Join a mission where precision meets purpose, and every regulation you navigate brings better care to millions.

Major Accountabilities

• New Product Registrations - With supervision, evaluate, and prepare drug registration applications in a timely manner and follow through the application during the evaluation phase to achieve a favorable outcome
• Maintenance of registered products - With supervision, maintain registration of currently approved products (initiation and preparation of variation/ and renewal applications as per the plan communicated from the DRA manager/Head).
• Coordinate with DRA manager/head to ensure correct and speedy implementation / consignments as per the approved applications (variation/ renewal/ site transfer/ site registration/leaflet update).
• Maintain, with supervision, the internal DRA database accurate and updated: Dragon/DASA
• Relationships within and outside the company - Develop and maintain good working relationships with other Novartis departments both locally and with Head Office and with third-party vendors.
• With Supervision, Review PPMS and ensure AQWA Launch request are prepared and launched on time.
• With Supervision, ensure full support to Global regulatory compliance initiatives in Saudi.
• Pharmacy or related science degree.
• Minimum 1 year of RA Experience in reputable pharmaceutical company.
• Experience handling a portfolio/product and dealing with stakeholder such as SFDA and governmental agency.
• Must be Saudi national.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Specialist, Regulatory Affairs page is loaded Specialist, Regulatory Affairs Apply locations SA Riyadh time type Full time posted on Posted 8 Days Ago job requisition id JR1999 ARA-P1-10

Responsible for dossier compilation and submission • Responsible for ensuring compliant life cycle management in compliance with market regulations • Manage local Labeling and AWs creation and submission • Maintain the regulatory processes within the department, including assist with the development and implementation of regulatory procedures and SOP, • Manage Communication with regulatory agencies or related interface

Additional Job Description:

Primary Location:

Job Posting Date:

Job Type:

Mundipharma is a global healthcare company with a presence across Africa, Asia Pacific, Canada, Europe, Latin America, and the Middle East.

Mundipharma is dedicated to bringing innovative treatments to patients in the areas of Pain Management, Infectious Disease and Consumer Healthcare as well as other severe and debilitating disease areas. Our guiding principles, centered around Integrity and Patient-Centricity, are at the heart of everything we do.

For more information about Mundipharma's guiding principles and commitment to diversity and inclusion visit:

Specialist, Regulatory Affairs page is loaded Specialist, Regulatory Affairs Apply locations SA Riyadh time type Full time posted on Posted 8 Days Ago job requisition id JR1999 ARA-P1-10

Responsible for dossier compilation and submission • Responsible for ensuring compliant life cycle management in compliance with market regulations • Manage local Labeling and AWs creation and submission • Maintain the regulatory processes within the department, including assist with the development and implementation of regulatory procedures and SOP, • Manage Communication with regulatory agencies or related interface

Additional Job Description:

Primary Location:

Job Posting Date:

Job Type:

Mundipharma is a global healthcare company with a presence across Africa, Asia Pacific, Canada, Europe, Latin America, and the Middle East.

Mundipharma is dedicated to bringing innovative treatments to patients in the areas of Pain Management, Infectious Disease and Consumer Healthcare as well as other severe and debilitating disease areas. Our guiding principles, centered around Integrity and Patient-Centricity, are at the heart of everything we do.

For more information about Mundipharma's guiding principles and commitment to diversity and inclusion visit:

Specialist, Quality & Regulatory Affairs

At Cardinal Health, we aim to be a trusted partner, offering a broad range of innovative solutions that help our customers provide cost-efficient, more effective healthcare. Join our team of 50,000 humble partners striving each day to make healthcare more efficient, providers more effective, and patients as healthy as possible.

We are currently looking to recruit a Specialist Quality & Regulatory Affairs based in our Riyadh office in Saudi Arabia, reporting to the Quality and Regulatory Affairs Manager, you will be responsible for, but not limited to, the following:

• Ensuring accurate and timely registration of products with competent authorities for KSA and other EMEA markets.

• Provide Quality & Regulatory Affairs support for EMEA markets, in compliance with applicable regulations and standards to ensure timely commercialization of products.

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

• Support regional distribution control (in compliance with applicable regulations and standards) to ensure timely commercialization of products.

• Review and validate regulatory data executing outbound flow.

• Ensure deployment and improvement of regulatory document related to new project development.

• Support as required the EMEA QRA team to ensure quality and regulatory compliance in accordance with national and European regulations.

• Act as the QRA representative in regional project meeting.

Essential Functions and Responsibilities

With moderate supervision, you will be responsible for the following Regulatory and Quality activities:

• Developing and implementing regulatory strategies and processes to ensure timely commercialization of products in compliance with applicable regulations and standards.

• Preparing documentation to support product registration and modifications according to project phase implementation.

• Overall registration strategies, coordination, implementation, execution, control and completion of product registrations in EMEA countries.

• Providing Regulatory intelligence.

• Supporting communication with our local agent and distributors in EMEA countries.

• Acting as QRA representative in the project implementation and work activity with various stakeholders.

• Notification to the regional quality and regulatory team for sharing status’ & updates of ongoing projects.

• Monitoring of local Regulatory environment, new regulations and supporting feedback and gap assessments to international Regulatory departments and business partners that impact projects.

• Ensuring follow-up/improvement of the distribution control procedure.

• Maintaining and archiving of all regulatory documentation in the region.

• Where needed, supporting the reporting of Serious Adverse Events to Competent Authority(ies) in EMEA.

• Ensuring compliance with quality procedures, laws and regulations of the applicable markets.

• Communicating business related issues or opportunities to next management level.

• Ensuring personal and company compliance with all local and company regulations, policies, and procedures.

• Training and deployment of local tools related to distribution control.

• Ensuring QRA administrative tasks related to assigned projects are completed.

• Perform other duties assigned as needed.

Qualifications and Experience

• BA/BS in Scientific discipline or equivalent work experience (3 years min).

• BS degree in Pharmacy, Medicine, Physical or Biological science or similar obtained by experience.

• Minimum of 3 years’ experience in Regulatory Affairs in Saudi Arabia and MEA region.

• Fluency in written and verbal English and Arabic is mandatory.

• Consistent background and knowledge of SFDA regulations for Medical Devices, strong connections with SFDA will be preferred.

• Must be proficient with MS Office applications.

• Excellent communication skills (verbal and written).

• Project management skills preferred.

• Problem solving skills.

• Presentation skills preferred.

• High degree of initiative.

• Open minded, listens to others.

• Able to manage complexity within a matrix organization.

• At ease in international environment.

• Hands on/can do attitude.

• Excellent attention to details.

Benefits

• Comprehensive local medical insurance for the employee and his/her family

• Various allowances

• Long term disability support, etc.

The Company

Headquartered in Dublin, Ohio, Cardinal Health (NYSE: CAH) is a health care services company that improves the cost-effectiveness of healthcare. As the business behind healthcare, Cardinal Health helps pharmacies, hospitals and ambulatory care sites focus on patient care while reducing costs, improving efficiency and quality, and increasing profitability. Cardinal Health is an essential link in the healthcare supply chain, providing pharmaceuticals and medical products to more than 100,000 locations each day and is also the industry-leading direct-to-home medical supplies distributor. The company is a leading manufacturer of medical and surgical products, including gloves, surgical apparel and fluid management products. In addition, the company supports the growing diagnostic industry by supplying medical products to clinical laboratories and operating the nation's largest network of radio pharmacies that dispense products to aid in the early diagnosis and treatment of disease. Ranked #14 on the Fortune 500 , Cardinal Health employs more than 50,000 people worldwide .

Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.

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Join to apply for the Sr. Specialist - Regulatory Affairs role at Julphar

Join to apply for the Sr. Specialist - Regulatory Affairs role at Julphar

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.
  
  

• 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.
  
  

• Bachelor of Pharmacy.
  
  

• 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
  
  

• Seniority level Mid-Senior level

• Employment type Full-time

• Job function Legal
• Industries Pharmaceutical Manufacturing

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Riyadh, Riyadh, Saudi Arabia 22 hours ago

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