Deputy Manager - Regulatory Affairs

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