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Biophore
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Executive Regulatory Affairs- API

Executive Regulatory Affairs- API

Biophore

3 - 8 years

2 - 6 Lacs

Hyderabad

Posted:2 months ago| Platform:

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Skills Required

usfda regulatory regulatory affairs emerging markets dmf

Work Mode

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

Biotechnology

Hyderabad

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Executive Regulatory Affairs- API