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.