Manager - Regulatory Affairs

Job Summary

The Manager - Regulatory Affairs will be responsible for overseeing US regulatory operations, defining regulatory strategies, and ensuring compliance for product portfolios in the US market. This is a leadership role requiring extensive regulatory expertise and stakeholder management.

Key Responsibilities

- Define and execute US regulatory strategies for product development and approvals

- Oversee ANDA, NDA, DMF submissions, amendments, and post-approval activities

- Act as the primary point of contact for USFDA communications

- Lead and manage the regulatory affairs team

- Evaluate regulatory risks and provide strategic guidance to business leadership

- Ensure compliance with evolving USFDA regulations and guidelines

- Support due diligence, audits, inspections, and regulatory intelligence activities

Required Skills & Qualifications

- 12-15 years of experience in US Regulatory Affairs

- Proven expertise in USFDA regulatory strategy and submissions

- Strong leadership and people management experience

- Excellent understanding of eCTD lifecycle management

- Strong decision-making, communication, and stakeholder management skills