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

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

Feel free to reach out in case of any queries.