Associate Director, Regulatory Affairs

EPM Scientific; North Carolina; On-site; USD 180,000 - 280,000; Full time

Job summary

EPM Scientific in the United States is seeking an Associate Director, Regulatory Affairs Strategy to drive global regulatory strategy development for development and commercial programs. You will lead interactions with health authorities and oversee regulatory submissions across multiple programs, ensuring timelines and compliance.

The role offers significant cross-functional exposure and the opportunity to support product lifecycle management from development through commercialization, with a

Qualifications

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

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.

Skills

Regulatory strategy

Global submissions

Cross-functional collaboration

Project management

Communication skills

Lifecycle management

Health authority interaction

Education

Bachelor's degree

Advanced degree preferred

Job description

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.