30 Regulatory Affairs jobs in Saudi Arabia

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:

Job Description Summary

Job Description

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.

Minimum Requirements

• 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.

#LI-Onsite

Skills Desired

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.

#LI-Onsite

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.

Job Description Summary

Job Description

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.

Minimum Requirements

• 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.

Skills Desired

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:

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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