Associate Director, Regulatory Affairs – Ad & Promo (CNS)

Scorpion Therapeutics; Durham (NC); On-site; USD 180,000 - 240,000; Full time

Job summary

Definium in the US is seeking an Associate Director, Regulatory Affairs (Advertising & Promotion) to oversee promotional materials for psychiatric therapeutics, including CNS targets. You will lead reviews, ensure compliance, and coordinate FDA interactions to facilitate timely approvals.

This role requires strong background in pharma regulatory affairs, 8+ years in the field, and mastery of FDA promotion rules. On-site position with potential for strategic impact across product communications.

Qualifications

• BS in science; advanced degree preferred.
• 8+ years in pharma with at least 5 in regulatory affairs.
• Strong knowledge of FDA promotion regulations and advertising approval processes.
• Experience supporting product communications.

Responsibilities

• Review and approve promotional content, social media posts, and medical materials.
• Liaise with FDA OPDP/APLB.
• Manage interactions and submissions with regulatory authorities.
• Ensure compliance with FDA, PhRMA, and company policies.
• Develop and implement regulatory review processes.
• Provide regulatory training to teams.

Skills

Regulatory affairs

FDA promotion regulations

Medical communications

Education

BS in science

Advanced degree preferred

Tools

Veeva Promomats

Job description

Definium in the US is seeking an Associate Director, Regulatory Affairs (Advertising & Promotion) to oversee promotional materials for psychiatric therapeutics, including CNS targets. You will lead reviews, ensure compliance, and coordinate FDA interactions to facilitate timely approvals.

This role requires strong background in pharma regulatory affairs, 8+ years in the field, and mastery of FDA promotion rules. On-site position with potential for strategic impact across product communications.