RA Manager - US Market

Job Location : Vadodara

Total Opening : 1

Experience : 12+ Years

No Salary bar for right candidate

1. Regulatory Strategy & Planning

• Develop and execute regulatory strategies for 

  US market submissions (ANDA, NDA 505(b)(2), IND, DMF, amendments, supplements, annual reports).

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

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

  eCTD format

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• Ensure accuracy and completeness of 

  ANDA/NDA/IND submissions

  .
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• 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.
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• Prepare teams for 

  pre-ANDA, pre-NDA, and PAI/inspection readiness meetings

  .
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• 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)

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• Ensure compliance with 

  labeling updates, REMS requirements, and safety reporting

  .
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• Track and implement 

  Orange Book updates, RLD changes, and product-specific guidances

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5. Compliance & Audit

• Maintain up-to-date knowledge of 

  US FDA regulations, guidance documents, and enforcement trends

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• Ensure site compliance with 

  regulatory commitments and cGMP requirements

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• Support internal audits and 

  USFDA inspections

   by providing regulatory documents and justifications.

6. Leadership & Team Development

• Supervise, train, and mentor junior regulatory associates/executives.
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• Build cross-functional alignment with 

  Formulation, Analytical, QA, Clinical, and Supply Chain teams

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• Represent Regulatory Affairs in 

  management review meetings and strategic decision-making