About the role
- Lead and manage end-to-end regulatory activities predominantly for US ANDA submissions and post-approval lifecycle management for complex sterile dosage forms.
- Guide and supervise a team of 4–5 senior regulatory associates, providing strategic direction, mentoring, and performance oversight.
- Act as a regulatory lead in cross-functional teams (CFTs) involving R&D, QA, QC, AR&D, Formulation, and Project Management to resolve regulatory deficiencies and plan responses.
- Strategize and draft FDA deficiency responses, ensuring alignment with regulatory expectations and internal timelines.
- Liaise with R&D for preparing controlled correspondences, pre-submission meetings and teleconferences packages, as needed.
- Ensure timely and compliant filing of supplements (PAS, CBE-30, CBE-0), annual reports, and amendments.
- Monitor and interpret evolving FDA regulations and guidances; assess impact and implement regulatory strategy changes accordingly.
- Represent Regulatory Affairs in partner meetings and contribute to regulatory planning and communication with external stakeholders and business partners.
- Review and approve critical CMC documentation, bridging technical content with regulatory requirements.
- Drive continuous improvement in regulatory processes, systems, and team capabilities.