Manager

2 weeks ago

West India Gujarat Baska Panchmahal BDR Group Full time ₹ 12,00,000 - ₹ 36,00,000 per year
1. Regulatory Strategy & Planning

  • Develop and execute regulatory strategies for US market submissions (ANDA, NDA 505(b)(2), IND, DMF, amendments, supplements, annual reports).

  • Interpret US FDA regulations, guidances, and ICH requirements, providing regulatory intelligence to senior management and project teams.

  • Assess regulatory risks and propose mitigation strategies during product development.

2. Dossier Preparation & Submission

  • Author, review, and finalize CMC sections (Module 2 & 3) of submissions.

  • Oversee the preparation, publishing, and electronic submission of regulatory dossiers in eCTD format.

  • Ensure accuracy and completeness of ANDA/NDA/IND submissions.

  • Coordinate with API suppliers, CMOs, and internal stakeholders for DMF references, LOAs, and compliance documents.

3. Health Authority Interactions

  • Serve as the primary contact with US FDA for product-specific queries, deficiency letters, and teleconferences.

  • Prepare teams for pre-ANDA, pre-NDA, and PAI/inspection readiness meetings.

  • Draft and review responses to FDA Information Requests (IRs), Complete Response Letters (CRLs), and deficiency queries.

4. Lifecycle Management

  • Manage post-approval changes (PAS, CBE-30, CBE-0, annual reports).

  • Ensure compliance with labeling updates, REMS requirements, and safety reporting.

  • Track and implement Orange Book updates, RLD changes, and product-specific guidances.

5. Compliance & Audit

  • Maintain up-to-date knowledge of US FDA regulations, guidance documents, and enforcement trends.

  • Ensure site compliance with regulatory commitments and cGMP requirements.

  • Support internal audits and USFDA inspections by providing regulatory documents and justifications.

6. Leadership & Team Development

  • Supervise, train, and mentor junior regulatory associates/executives.

  • Build cross-functional alignment with Formulation, Analytical, QA, Clinical, and Supply Chain teams.

  • Represent Regulatory Affairs in management review meetings and strategic decision-making.

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