Regulatory Affairs (EU/USA/Brazil / ROW / LATAM (Mumbai)

Regulatory Affairs (EU/USA/Brazil / ROW / LATAM (Mumbai)

15 Oct
|
Themis Medicare
|
Mumbai

15 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

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