Regulatory Affairs Specialist
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About the Role
Responsible for supporting the preparation, submission, and maintenance of marketing authorizations for assigned products, under the supervision of the Country Lead / Associate Director Regulatory Affairs.
Key Skills for This Role
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Job Description
Responsible for supporting the preparation, submission, and maintenance of marketing authorizations for assigned products, under the supervision of the Country Lead / Associate Director Regulatory Affairs.
Ensures compliance with applicable regulatory requirements, manages labeling and artwork activities, supports cross-functional teams, and maintains effective relationships with internal and external stakeholders.
Regulatory Submissions And Maintenance
- Prepare and submit new marketing authorization applications for assigned products.
- Manage lifecycle activities for approved products, including variations, renewals, PSURs, and supplemental applications.
- Track product registrations and major new indications in coordination with relevant internal and external stakeholders.
- Compliance and Documentation
- Ensure timely preparation and maintenance of product information, including SmPCs, patient leaflets, physician circulars, and packaging materials in line with Company and local requirements.
- Support implementation of prescribing information and other regulatory updates within required timelines.
- Maintain accurate and complete regulatory files, archives, and databases.
- Contribute to SOP development and implementation of updated regulatory requirements.
- Labeling and Artwork
- Review translations, QRD checks, and linguistic quality of labeling documents.
- Coordinate artwork preparation, proofing, and updates in accordance with artwork management procedures.
- Ensure correct use of internal systems for artwork generation, submissions, approvals, and record keeping.
Regulatory Intelligence And Stakeholder Management
- Monitor local and regional regulatory changes and communicate relevant updates.
- Collect and share regulatory intelligence with key stakeholders.
- Maintain strong working relationships with internal teams and external authorities.
- Participate in regulatory industry groups and internal workstreams as assigned.
Qualifications And Experience
- B.Sc. in Pharmacy or another Life Science discipline required.
- Minimum 2 years’ experience in the pharmaceutical industry, preferably in regulatory affairs, medical, or laboratory roles.
- Strong written and verbal communication skills.
- Excellent organization, planning, and attention to detail.
- Ability to manage multiple priorities and work under pressure.
- Strong teamwork and independent working capability.
- Proficiency in Arabic and English.
Required Skills
Adaptability, Detail-Oriented, Divestitures, Electronic Common Technical Document (eCTD), Employee Training Programs, Internal Customers, Life Science, Management Process, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Product Approvals, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Documents, Regulatory Experience, Regulatory Issues, Regulatory Reporting, Regulatory Strategy Development, Regulatory Submissions, Stakeholder Engagement, Stakeholder Management, Standard Operating Procedure (SOP), Technical Writing**Preferred Skills:**
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.
Job Posting End Date
05/19/2026* **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.**
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