Associate Director, Regulatory Affairs
About The Position
The Associate Director partners with regulatory leadership to obtain and maintain regulatory filings and registrations for domestic and international regions. The role coordinates with internal team members and external parties, including regulatory bodies, vendors, and consultants, to maintain up-to-date information on regulatory requirements and product submissions. This is a hybrid, headquarters-based position that typically requires on-site presence three days per week. The Associate Director provides team and department leadership, manages interactions with domestic and international health authorities, and develops and executes regulatory strategies supporting timely product approval and lifecycle management. The role leads preparation, review, and submission of regulatory documents for new products and changes to existing applications, oversees reporting requirements for investigational products, and ensures regulatory files are accurate, current, complete, and inspection-ready. It also partners cross-functionally to advance development programs and regulatory objectives, provides guidance and coaching to colleagues, and contributes to regulatory procedures, policies, and processes.
Requirements
- Minimum of 7 years of relevant regulatory experience.
- Strong analytical and problem-solving skills.
- Strong written and verbal communication skills, including the ability to interact effectively and influence others.
- Strong attention to detail.
- Ability to balance and manage multiple projects from multiple stakeholders in a timely and quality manner.
- Applicants must be currently authorized to work in the United States on a full-time basis.
Nice To Haves
- Advanced degree (M.S., Pharm.D., or Ph.D.) in life sciences, including chemistry, molecular biology, or similar.
Responsibilities
- Provide team and department leadership.
- Manage the company’s interactions with domestic and international health authorities.
- Develop and execute regulatory strategies to support timely approval and lifecycle management of company products.
- Lead preparation, review, and submission of regulatory documents for new products and changes to existing applications, including domestic and international submissions and registrations.
- Maintain current knowledge of applicable U.S. and international regulatory requirements, guidelines, and emerging developments; translate requirements into actionable plans and support organizational awareness and compliance.
- Partner cross-functionally with Clinical Operations, Clinical Development, Quality, and other functions to advance development programs and regulatory objectives.
- Collaborate with clinical teams to ensure regulatory submissions and clinical presentations are appropriately organized, accurate, complete, and supported by relevant data.
- Provide guidance, coaching, and subject-matter expertise to colleagues supporting assigned projects.
- Oversee regulatory reporting requirements for investigational products.
- Manage preparation for, participation in, and follow-up to meetings with FDA and other global health authorities.
- Ensure regulatory documentation and files are complete, accurate, current, and inspection-ready.
- Contribute to the development, implementation, and maintenance of regulatory standard operating procedures, policies, and processes.
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What This Job Offers
Job Type
Full-time
Career Level
Director
