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Regulatory Affairs - Formulations

Regulatory Affairs - Formulations

Biophore

0 - 2 years

1 - 2 Lacs

Hyderabad

Posted:1 week ago| Platform:

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Skills Required

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

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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

www.biophore.com

Biotechnology

Hyderabad

200+ Employees

90 Jobs

Key People

Dr. V. Raghavendra

Founder & CEO
Mr. Gupta H

Chief Financial Officer
Dr. Priya Sharma

Chief Scientific Officer

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