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Open nowPosted 8 days ago

Assistant Manager, Regulatory Affairs

Amneal India91 open roles

Where
India
Work mode
On site
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Your applicationOpen nowAssistant Manager, Regulatory AffairsAmneal India · India

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The clock on this job

Early applications get read.

13.5% of postings close within 7 days. Measured by our own scanner across the market. Amneal India postings stay open a median of 6 days.

Share of postings closed within
  1. 2.3%1 day
  2. 4.6%3 days
  3. 13.5%7 days
  4. 21.8%14 days
  5. 36.6%30 days
  6. 58.9%60 days
This job: posted 8 days ago

Amneal India median: 6 days open

The posting

Job Description

Key Responsibilities:

Regulatory Submissions & Documentation

  • Prepare, review, and submit high‑quality regulatory dossiers (IND/IMPD, BLA/MAA, ANDA/Abbreviated MAA where applicable) for global markets including USFDA, EMA.
  • Ensure accuracy and completeness of CTD/eCTD modules, with strong focus on CMC documentation for biologics/biosimilars.
  • Lead responses to regulatory queries, information requests, and deficiency letters within stipulated timelines.

Regulatory Strategy & Development Support

  • Contribute to regulatory strategy for development, registration, and lifecycle management of biosimilars/biologics.
  • Support planning of comparability protocols, analytical similarity strategy, clinical study design justification, and CMC development from a regulatory perspective.
  • Provide regulatory intelligence and impact assessment of new or updated US/EU/ICH guidelines relevant to biologics and biosimilars.

Lifecycle Management

  • Manage global lifecycle activities including post‑approval changes, variations, supplements, label updates, renewals, and annual reports.
  • Evaluate change controls to determine global regulatory impact and required submissions.

Cross‑Functional Collaboration

  • Collaborate with R&D, Process Development, Analytical, Quality Assurance, Manufacturing, Clinical, and Pharmacovigilance teams to ensure regulatory compliance throughout the product lifecycle.
  • Participate in technical review meetings and provide regulatory assessments for changes, deviations, and investigations.

Compliance & Inspection Readiness

  • Ensure compliance with global regulations, ICH guidelines, biosimilar-specific pathways, and regional expectations.
  • Support regulatory inspection readiness and assist in preparing teams for FDA, EMA, or other agency audits.

Regulatory Intelligence & Documentation Systems

  • Maintain up‑to‑date knowledge of evolving global regulations related to biologics, biosimilars, GMP/CMC, and digital submission requirements.
  • Support implementation or maintenance of internal regulatory information systems and document management tools.

Preferred Experience & Qualifications

Technical / Regulatory Expertise

  • 3–10 years of hands‑on experience in Regulatory Affairs for Biologics or Biosimilars.
  • Strong understanding of CMC requirements for large molecules including:Cell line development Upstream/Downstream processes Analytical characterization Specifications & control strategies Process validation Comparability protocols
  • Experience preparing submissions such as IND/BLA for USFDA and IMPD/MAA for EMA.

Global Regulatory Framework Knowledge

  • Deep familiarity with USFDA (351(k)), EMA (Biosimilar Pathway), ICH Q5–Q14 guidelines, and global expectations for biosimilar development.

Lifecycle Management Experience

  • Proven experience in post‑approval changes, variations, and maintenance activities for biologic products.

Functional Skills

  • Strong coordination and communication skills to interact with technical teams and regulatory agencies.
  • Ability to interpret guidelines and provide strategic regulatory guidance to influence product development.
  • Experience working on sterile/injectable, oncology, immunology, or specialty biologic portfolios will be an added advantage.

Qualifications

Qualifications

M. Pharm / MSc / PhD in Biotechnology, Biochemistry, Life Sciences, or related field.

Feel free to reach out in case of any queries.

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