Team Leader, RA
$100,000–$120,000 year
On-site · Hyderabad, Telangana, India
Job Summary
Lead and manage end-to-end regulatory activities for US ANDA submissions and post-approval lifecycle management for complex sterile dosage forms. Guide and supervise a team, act as regulatory lead in cross-functional teams, draft FDA deficiency responses, and ensure compliance in filing. Monitor emerging FDA regulations and represent Regulatory Affairs in external communications. Requires extensive experience and knowledge in US Regulatory Affairs, leadership, and strong collaboration skills.
Required Qualifications
- 15+ years of experience in US Regulatory Affairs
- Strong focus on sterile injectable products and complex generics
- In-depth knowledge of US FDA regulations and eCTD submissions
- Hands-on experience with FDA queries and timely responses
Desired Qualifications
- Experience with microsphere formulations
- Familiarity with peptides, BFS, nasal sprays, ophthalmics, ointments, and other sterile/non-oral dosage forms
- Strong leadership and project management skills
- Excellent communication and analytical capabilities
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