Associate Director, Regulatory Affairs

A growing biotechnology company focused on developing innovative therapies for patients with rare and serious diseases is seeking an Associate Director, Regulatory Affairs Strategy. This individual will play a key role in global regulatory strategy development, health authority interactions, and regulatory submissions across both development and commercial programs. The position offers significant cross-functional exposure and the opportunity to support products throughout the development and lifecycle management process.

Key Responsibilities

• Develop and execute regulatory strategies for development and commercial-stage programs.
• Support global approvals, post-approval activities, and lifecycle management submissions.
• Prepare and submit regulatory applications, including INDs, NDAs, and BLAs.
• Serve as the regulatory lead or support lead on assigned programs and workstreams.
• Support health authority meeting preparation and regulatory interactions.
• Manage regulatory timelines and communicate risks to key stakeholders.
• Collaborate with cross-functional teams to ensure successful execution of regulatory plans.
• Maintain compliance with evolving FDA and global regulatory requirements.
• Support SOP development and continuous process improvement initiatives.

Qualifications

• Bachelor's degree required; advanced scientific degree preferred.
• 8-10 years of regulatory affairs strategy experience within biotech or pharmaceutical organizations.
• Strong knowledge of FDA regulations related to drug development, INDs, NDAs, and BLAs.
• Experience supporting global regulatory submissions and lifecycle management activities.
• Ability to develop and implement regulatory strategies across multiple programs.
• Strong project management, organizational, and communication skills.
• Proven ability to collaborate effectively across cross-functional teams and external partners.
• Global regulatory experience and health authority interaction experience preferred.