Regulatory Advertising & Promotion — Associate Director

Definium Therapeutics; Durham (NC); On-site; USD 160,000 - 190,000; Full time

Benefits offered by this job

100% health benefits (medical, dental,

Vision coverage

401(k) with company match

Flexible time off

Parental leave

Equity

Job summary

Definium Therapeutics in Durham, NC seeks an Associate Director, Regulatory Affairs (Advertising and Promotion) to lead FDA submissions and promotional material reviews for assigned brands. The role requires collaboration with Commercial, Medical Affairs, and Legal to ensure compliance with FDA requirements and PhRMA DTC guidelines.

You will serve as the primary liaison with FDA (OPDP/APLB) for advertising matters, manage inquiries, and drive high-quality submissions and reviews across

Qualifications

• Minimum BS in scientific discipline; advanced degree preferred.
• 8+ years in pharma with at least 5 years in regulatory affairs.
• Experience in CNS is a plus.
• Expert knowledge of advertising promotion regulations and FDA guidance documents.
• Solid experience with promotional and medical review supporting product communications and FDA interactions.
• Experience with Promomats a strong plus.

Responsibilities

• Serve as internal SME on FDA Advertising & Promotion matters for assigned product(s).
• Review and approve promotional and medical materials in PromoMats.
• Review and approve social media posts.
• Liaise with OPDP/APLB (FDA) as needed as the single point of contact.
• Manage interactions with OPDP/APLB and prepare advisory responses.
• Ensure timely and accurate FDA submissions (2253).
• Ensure changes in prescribing information are reflected in promotional materials.
• Develop streamlined processes for promotional materials and related workflows.
• Provide regulatory training on FDA requirements and company policies.

Skills

Regulatory affairs

FDA guidelines

Promotional materials review

Cross-functional collaboration

Education

Bachelor's degree in scientific discipline

Advanced degree in science

Tools

Veeva Promomats

Job description

Definium Therapeutics in Durham, NC seeks an Associate Director, Regulatory Affairs (Advertising and Promotion) to lead FDA submissions and promotional material reviews for assigned brands. The role requires collaboration with Commercial, Medical Affairs, and Legal to ensure compliance with FDA requirements and PhRMA DTC guidelines.

You will serve as the primary liaison with FDA (OPDP/APLB) for advertising matters, manage inquiries, and drive high-quality submissions and reviews across