Associate Director - Regulatory Affairs

The Associate Director partners with regulatory leadership in obtaining and maintaining regulatory filings and registrations for domestic and international regions. The Associate Director will coordinate activities with internal team members and external parties (e.g., regulatory bodies; vendors; consultants) to maintain up-to-date information on regulatory requirements and product submissions.

This is a hybrid role that typically requires on-site presence three days per week.

Responsibilities:

• Provides team and department leadership
• Manages the company’s interactions with domestic and international health authorities
• Develops and executes regulatory strategies to support the timely approval and lifecycle management of company products
• Leads the preparation, review, and submission of regulatory documents for new products and changes to existing applications, including domestic and international submissions and registrations
• Maintains current knowledge of applicable U.S. and international regulatory requirements, guidelines, and emerging developments. Translates regulatory requirements into practical, actionable plans and follows through to support organizational awareness and compliance
• Partners cross-functionally with Clinical Operations, Clinical Development, Quality, and other functions to advance development programs and regulatory objectives
• Collaborates with clinical teams to ensure that regulatory submissions and clinical presentations are appropriately organized, accurate, complete, and supported by relevant data
• Provides guidance, coaching, and subject-matter expertise to colleagues supporting assigned projects
• Oversees regulatory reporting requirements for investigational products
• Manages the preparation for, participation in, and follow-up to meetings with FDA and other global health authorities
• Ensures that regulatory documentation and files are complete, accurate, current, and inspection-ready
• Contributes to the development, implementation, and maintenance of regulatory standard operating procedures, policies, and processes

Preferred Skills, Qualifications and Technical Proficiencies:

• Strong analytical and problem-solving skills
• Strong written and verbal communication skills, including the ability to interact effectively and to influence
• Strong attention to detail
• Ability to balance and manage multiple projects from multiple stakeholders in a timely and quality manner

Preferred Education and Experience:

• Bachelor’s degree. Advanced degree (M.S., Pharm.D., Ph.D.) in life sciences (including chemistry, molecular biology, or similar) preferred
• Minimum of 7 years of relevant regulatory experience

The pay range that the Company reasonably expects to pay for this headquarters-based position is $215,300-$253,200; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.

Applicants must be currently authorized to work in the United States on a full-time basis.