Job Description
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
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
- 8-10 years of experience in US Regulatory Affairs
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