Assistant Manager, Regulatory Affairs (DMF Peptide Exposure)

Amneal Pharmaceuticals

0 years

3 - 4 Lacs

Ahmedabad

Posted:2 days ago| Platform: GlassDoor logo

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Skills Required

api query support management compliance presentation documentation coordination manufacturing data writing communication strategy development planning diversity

Work Mode

On-site

Job Type

Part Time

Job Description

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

Masters in Chemistry or Organic Chemistry or M. Pharm

Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.

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