Sr Regulatory Affairs

Role: Sr Regulatory Affairs

Shift: 6AM-3PM IST

Location: Hyderabad

Responsibilities

• Independently prepare, review, and contribute to high-quality regulatory submissions (e.g. BLA, NMA, IND components) for biological and cell and gene therapy products, in line with ICH, FDA, EMA, TGA, and Medsafe requirements.
• Act as a core contributor or lead author for assigned CMC, clinical, and/or non-clinical sections of regulatory dossiers.
• Coordinate, compile, and author responses to regulatory questions and RFIs, ensuring clear scientific justification and adherence to timelines.
• Perform gap analyses on source documentation against applicable ICH guidelines and FDA/EMA guidances for cell and gene therapies (including CAR T-cell products), and clearly communicate gaps and risks to the Regulatory Manager and relevant SMEs.
• Support post-approval activities, including variations, amendments, and lifecycle management of registered products.
• Maintain accurate and current regulatory documentation, submission trackers, and archival records in electronic document management systems.
• Monitor and interpret changes in the global regulatory environment and assess their impact on development programs and approved products.
• Contribute to the development and execution of regulatory strategies for new and existing products, including identification of regulatory risks and mitigation approaches.
• Build and maintain effective working relationships with internal stakeholders and regulatory authorities through clear, professional communication.
• Participate in, and where appropriate lead, initiatives to improve regulatory processes, tools, and ways of working within the team.

Qualifications &

Experience

• Minimum BSc in biological sciences or a related discipline; MSc strongly preferred.
• Minimum 5+ years experience in Regulatory Affairs within the pharmaceutical or biotechnology industry, with demonstrated experience in biological and/or cell and gene therapy products.
• Proven hands-on experience contributing to major regulatory submissions (e.g. BLA, NMA, IND), within CMC, clinical, or non-clinical modules.
• Experience supporting responses to regulatory questions and post-approval changes.
• Strong working knowledge of FDA, EMA, ICH, and other relevant international regulatory frameworks; experience with TGA and/or Medsafe
• desirable.
• Advanced proficiency in Microsoft Word, with demonstrated experience formatting and managing complex regulatory documents; experience with regulatory publishing or submission management systems (e.g. Lorenz, Accumen or equivalent) is an advantage.
• Experience working in global, cross-functional teams, ideally across multiple time zones.