Team Leader, RA

Job Details

Job Location

Prashanti Nagar IE Kukatpally Hyderabad, TELANGANA

Salary Range

$1300000.00 - $2000000.00 Salary/month

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.

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