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MSN Group
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Assistant Manager - Quality Assurance (Regulatory Support) (API Plan

Assistant Manager - Quality Assurance (Regulatory Support) (API Plan

MSN Group

10 - 14 years

10 - 14 Lacs

patancheru

Posted:1 day ago| Platform:

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Skills Required

quality assurance

Work Mode

Work from Office

Job Type

Full Time

Job Description

Key Responsibilities:

Regulatory Support & DMF Filing:

Support the Regulatory Affairs team in the preparation, compilation, and submission of Drug Master Files (DMFs) for new products across different regulatory agencies.
Coordinate with cross-functional teams (QA, QC, Production, R&D) for timely data collection and documentation.

Regulatory Deficiencies & Queries:

Review, analyze, and address regulatory deficiencies raised by authorities within stipulated timelines.
Prepare clear and concise responses to regulatory queries in coordination with internal departments.

Assessment & Amendments:

Prepare and review country-specific regulatory assessments and amendments based on current regulatory guidelines and product variations.
Ensure compliance with regional submission formats and documentation requirements.

Customer Communication:

Address customer queries related to DMF and regulatory documentation promptly and professionally.
Provide technical support to customers for regulatory submissions and clarifications.

Regulatory Compliance:

Maintain up-to-date knowledge of global regulatory guidelines, compliance requirements, and submission procedures.
Support audits and inspections by ensuring accuracy and completeness of regulatory documentation.

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