14 Oct
|
Themis Medicare
|
Mumbai
14 Oct
Themis Medicare
Mumbai
Roles and Responsibilities
- Manage regulatory dossiers for EU, USA, Brazil, ROW & LATAM regions.
- Prepare compilation documents for product variations including STPs, IBs, PSUs, PMHFAs etc.
- Ensure timely submission of dossiers to concerned authorities through respective portals.
- Coordinate with cross-functional teams for preparation of dossiers and follow-up on submissions.
- Maintain accurate records of all submitted documents and track progress.
Desired Candidate Profile
- 5-8 years of experience in Regulatory Affairs with expertise in Life Cycle Management.
- Bachelor's degree in Pharmacy (B.Pharma) or Master's degree (M.Pharma) from a recognized institution.
- Robust understanding of pharmaceutical regulations governing different regions such as EU GMP/Gxp guidelines, FDA CFR21 Part 210/820 requirements for USA market approval.
📌 Regulatory Affairs (EU/USA/Brazil / ROW / LATAM (Mumbai)
🏢 Themis Medicare
📍 Mumbai