Regulatory Affairs Executive (Mumbai)

Regulatory Affairs Executive (Mumbai)

03 Nov
|
Centaur Pharmaceuticals
|
Mumbai

03 Nov

Centaur Pharmaceuticals

Mumbai

Qualification: M.Pharm /B.Pharm/M.Sc. having 4-8 years experience in ROW markets- LATAM/ AFRICA/ SOUTH EAST ASIA/ MENA/ GCC

- Compilation and submission of Fresh & Renewal dossiers for registration in ROW countries based on CTD/ACTD/Country specific format for different dosage forms.
- Preparation and submission of query response raised by regulatory authority.
- Preparation and submission of post-registration variations
- Preparation and submission of Company Registration Documents as per the country requirements.
- Co-ordination with various departments such as Quality Assurance, Quality Control, R & D, Marketing Department, Analytical development labs, Manufacturing plant, Administrative department etc. for collection of various technical documents as required for registration.
- Compilation and Checking of Tender Documents.
- Co-ordination with art department for Artworks.

Arrange & Courier the registration samples

📌 Regulatory Affairs Executive (Mumbai)
🏢 Centaur Pharmaceuticals
📍 Mumbai

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