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.

M. Pharm / Ph.D. in Pharmaceutical Sciences or related disci

• 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.