
Senior Regulatory Affairs Executive
15 hours ago
Job Title: Senior Regulatory Executive RoW Market ( LATAM Specially)
Location: Ahmedabad
Experience: 5–7 years in Regulatory Affairs (RoW markets)
Qualification: B.Pharm / M.Pharm / Life Sciences
Key Responsibilities:
- Prepare & review CTD/eCTD/non-CTD dossiers for new registrations, renewals, and variations.
- Coordinate with agents/distributors for submissions and query responses.
- Track timelines and ensure compliance with regulatory guidelines (LATAM, Africa, CIS, Asia).
- Manage product lifecycle: variations, renewals, packaging/labelling updates.
- Maintain regulatory databases and trackers.
Key Skills:
- Strong knowledge of RoW regulatory requirements & dossier formats.
- Experience with LATAM countries (Brazil, Mexico, Argentina, Chile, etc.).
- Excellent documentation, coordination & communication skills.
- Proficiency in MS Office & regulatory databases.
Other Details:
- Will lead a team of 4 RAs and report to Director.
- Immediate joiners preferred (short notice period).
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