Assistant Manager, Regulatory Affairs

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.
• M. Pharm / MSc / PhD in Biotechnology, Biochemistry, Life Sciences, or related field.
• Feel free to reach out in case of any queries.