Assistant Manager, Regulatory Affairs (DMF Peptide Exposure)

Amneal Pharmaceuticals

8 - 12 years

11 - 13 Lacs

Ahmedabad

Posted:1 day ago| Platform:

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Skills Required

USFDA Query resolution Compliance Anda Technical writing Regulatory compliance Management Assistant Manager Regulatory Affairs Strategy development

Work Mode

Work from Office

Job Type

Full Time

Job Description

:

Prepare and review Peptide API Drug Master Files (DMFs) for submission to the US FDA and other regulatory agencies.
Handle deficiency responses and interact with regulatory authorities for query resolution and clarification.
Prepare and manage ANDA Drug Substance Modules and support associated submissions and updates.
Compile and submit DMFs, and support any lifecycle management or post-submission queries.
Maintain current knowledge of regulatory guidelines and ensure regulatory compliance across all submissions.
Participate in internal and external project discussions and contribute to the preparation of regulatory project presentation slides and documentation.
Ensure coordination between R&D, Quality, and Manufacturing teams for gathering and verifying technical data.
Exhibit strong technical writing and communication skills to ensure clarity and compliance in submissions.
Support regulatory strategy development and planning for new drug substance filings.

Required Skills:

Peptide API DMF Preparation | Expert
DMF Review & Deficiency Responses | Expert
Regulatory Knowledge | Expert
Technical Writing | Expert
Communication & Coordination | Expert

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