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Executive Regulatory Affairs- API

Executive Regulatory Affairs- API

Biophore

3 - 8 years

2 - 6 Lacs

Hyderabad

Posted:1 week ago| Platform:

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Skills Required

usfda regulatory regulatory affairs emerging markets dmf

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Work from Office

Job Type

Full Time

Job Description

Roles and Responsibilities Prepare dossiers for DMF (Dossier Management Facility) submissions to US FDA, including eCTD structure preparation, data compilation, and review. Coordinate with cross-functional teams to ensure timely submission of regulatory documents. Review and compile technical documentation for various global markets, ensuring compliance with regulations. Manage change controls, variation applications, renewals, variations, extensions, and post-approval changes. Provide guidance on regulatory requirements to internal stakeholders. Desired Candidate Profile 6-10 years of experience in Regulatory Affairs or related field (API industry preferred). MS/M.Sc(Science) in Chemistry or equivalent qualification. Strong understanding of emerging markets' regulations (US FDA). Excellent communication skills with ability to work effectively across functions.

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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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