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Biophore
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Regulatory Affairs - Formulations

Regulatory Affairs - Formulations

Biophore

0 - 2 years

1 - 2 Lacs

Hyderabad

Posted:1 month ago| Platform:

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Skills Required

Formulation Research Development drug regulatory affairs Dmf US Market Regulatory Affairs Anda

Work Mode

Work from Office

Job Type

Full Time

Job Description

Roles and Responsibilities Manage ANDAs (Abbreviated New Drug Applications) for US market approval. Coordinate with DMF (Dossier Management Facility) team for dossier compilation and submission. Prepare dossiers, variations, renewals, and amendments according to FDA guidelines. Ensure timely review of documents by internal teams and external agencies. Maintain accurate records of all regulatory correspondences. Desired Candidate Profile MS/M.Sc(Science) or M.Pharma degree from a recognized institution. Strong understanding of formulation research development principles. Excellent communication skills with ability to work effectively with cross-functional teams. 0-3 years of experience in Regulatory Affairs - Formulations with expertise in drug regulatory affairs.

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Biophore

Biotechnology

Hyderabad

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Regulatory Affairs - Formulations