Emcure
Officer/Executive Regulatory Affairs -API
Skills
2 months ago
Share this opportunity
Share this opportunity to other talents of your network:
✓ Offer them a visibility boost with clients.
✓ Help your contacts find their next job.
Important information
Contract type:
Permanent
Location:
Pune, Maharashtra, India
Work mode:
Onsite
Published on:
26 August 2026
What they need
- Preparation and filing of original DMFs, amendments, and annual reports for USFDA.
- Preparation and submission of ASMFs, ASMF updates, CEP applications/revisions for Europe and regulatory documents for Canada market.
- Handling regulatory submissions through DocuBridge & EDUCE software.
- Maintaining regulatory documentation and ensuring compliance with US, European, and Canadian regulatory requirements*.*
Preferred Skills: Experience in DMF, ASMF, CEP submissions, DocuBridge & EDUCE software, and good knowledge of US, EU, and Canada regulatory requirements.
Qualification : B.Pharm / M.Pharm / M.Sc.
Other offers great for you!
These companies are also looking for great profiles
Sherpa Accompagnement
Responsable Qualité - Plasturgie / Injection
Permanent contract
Brie-Comte-Robert, France
Onsite
Skills
17 hours ago
Quick apply
Bloomays
RPO freelance - 3j/semaine - Paris
Freelance
Paris, France
Onsite
Top Recruiter
Skills
9 hours ago
Quick apply
Anderson RH
EXPERT AWS- mise en conformité-sécurité-migration
Freelance
Paris, France
Hybrid
Skills
5 hours ago
Quick apply