Job Description
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
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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
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