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 recent 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.

📌 Assistant Manager, Regulatory Affairs (Sarkhej)
🏢 Amneal India
📍 Sarkhej