We are hiring a Regulatory Affairs Executive/Sr. Executive specializing in ROW (Rest of World) Markets for a leading pharmaceutical company in Ahmedabad. The role focuses on dossier preparation, submission, and compliance for semi-regulated and non-regulated markets, including LATAM, Africa, Southeast Asia, CIS, and the Middle East.
Key Responsibilities:
- Dossier Preparation & Submission: Compile and submit regulatory dossiers (CTD/eCTD/ACTD) for new registrations, renewals, and variations.
- Regulatory Compliance: Monitor and implement evolving regulations in ROW markets.
- Cross-functional Coordination: Liaise with R&D, QA/QC, and manufacturing teams for documentation.
- Labeling & Artwork Review: Ensure compliance in packaging and labeling materials.
- Product Lifecycle Management: Handle post-approval changes, renewals, and variations.
About the Hiring Company
A reputed pharmaceutical firm with a strong global presence, specializing in regulatory approvals for emerging markets. The company offers a collaborative work environment, career growth opportunities, and exposure to international regulatory frameworks.
Eligibility Criteria
Education & Experience:
- Qualification: B.Pharm/M.Pharm/M.Sc. (Life Sciences/Pharmacy-related fields).
- Experience: 3–7 years in regulatory affairs, preferably in ROW markets.
- Preferred Exposure: Experience in Africa, LATAM, GCC, CIS, or Southeast Asia markets is desirable.
Skills Required:
- Strong knowledge of ROW regulatory guidelines.
- Expertise in dossier compilation & submission.
- Proficiency in MS Office (Word, Excel, PowerPoint).
- Excellent communication and organizational skills.
How to Apply
Interested candidates meeting the eligibility criteria can email their updated CV to:
Email: bhoomika.patel@alchemytp.com
(Note: Only shortlisted candidates will be contacted for further process.)
