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Team Leader, RA
Prashanti Nagar IE Kukatpally Hyderabad, TELANGANA 500072Posted 1 weeks ago
Job Description
- 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.
- 15+ years of experience in US Regulatory Affairs with a strong focus on sterile injectable products and complex generics.
- Proven experience with microsphere formulations, peptides, BFS, nasal sprays, ophthalmics, ointments, and other sterile/non-oral dosage forms.
- In-depth knowledge of US FDA regulations, eCTD submissions, and FDA communication pathways.
- Hands-on experience in handling FDA queries, CRLs, and working closely with CFTs to compile timely and high-quality responses.
- Strong leadership, project management, and cross-functional collaboration skills.
- Excellent communication, analytical, and problem-solving abilities.