Job Summary
The Deputy Manager - Regulatory Affairs will independently manage US regulatory submissions and provide strategic input for product approvals and post-approval changes. This role requires strong regulatory expertise and leadership capability.
Key Responsibilities
- Lead preparation and submission of ANDA, NDA, DMF, amendments, and supplements
- Develop and implement US regulatory strategies for new and existing products
- Manage post-approval changes, renewals, and annual reports
- Review and approve regulatory documents prepared by junior team members
- Respond to USFDA deficiency letters and manage agency interactions
- Support audits, inspections, and compliance activities
- Mentor and guide junior regulatory team members
Required Skills & Qualifications
- 8-10 years of experience in US Regulatory Affairs
- In-depth understanding of USFDA regulations and submission processes
- Strong experience in eCTD submissions and lifecycle management
- Ability to manage multiple products and deadlines
- Strong analytical, communication, and leadership skills
(ref:iimjobs.com)
