Sr Regulatory Affairs
ThinkWise Consulting LLP
- Location
- Hyderabad, Telangana, India
- Job type
- Full-time
Required skills
- biotechnology
- cross-functional
About the role
Website:
thinkwise.co.in
Job details:
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.
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