Associate Director, Regulatory Affairs – Advertising and Promotion

Definium Therapeutics

Associate Director guiding FDA advertising and promotion compliance for Definium Therapeutics, a biopharmaceutical company developing psychedelic treatments. Leading promotional review, FDA interactions, submissions, and MLR strategy.

Posted 8/7/2026full-timeRemote • 🇺🇸 United StatesLead💰 $160,000 - $190,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expert knowledge of FDA Advertising and Promotion regulations, providing regulatory guidance and solutions for promotional materials. Proficient in managing interactions with FDA and ensuring compliance with promotional standards and processes.

Highest-signal resume keywords

FDA Advertising And Promotion RegulationsRegulatory Affairs ExperienceVeeva PromoMatsPromotional Material ReviewFDA 2253 Submissions

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory GuidanceDrug DevelopmentLabelingPromotional Plan DevelopmentMedical ReviewPhRMA DTC GuidelinesRegulatory TrainingCNS ExperienceFDA OPDP InteractionAdvisory-Comment Submissions

Tools & Technologies

Definium PromoMats

Industry Keywords

Pharmaceutical IndustryFDA Guidance DocumentsPromotional MaterialsAdvertisingMedical Communications

About the role

Key responsibilities & impact

Serve as the internal subject matter expert on FDA Advertising & Promotion matters for assigned product(s), providing regulatory advice and solutions to reconcile comments on draft promotional materials
Review and approve promotional and medical materials in Definium’s PromoMats system
Review and approve social media posts
Liaise with OPDP/APLB (FDA) as the company’s point of contact on advertising and promotional materials
Manage OPDP/APLB interactions, regulatory inquiries, advisory-comment submissions, and discussions with FDA staff
Ensure timely and accurate FDA 2253 submissions of US promotional materials
Ensure prescribing-information changes are reflected in promotional and advertising materials
Develop processes and standards for promotional materials and related activities
Provide regulatory training on FDA requirements, PhRMA DTC Guidelines, company policy, and PRC processes
Provide regulatory guidance during promotional plan development from concept through field implementation and lead MLR review activities

Requirements

What you’ll need

Minimum BS in scientific discipline; advanced degree in science preferred
Minimum 8 years’ experience in the pharmaceutical industry, including at least 5 years in regulatory affairs
Expert knowledge of advertising and promotion regulations and FDA Guidance documents
Technical experience in aspects of drug development and labeling
Solid experience supporting promotional and medical review for product communications
Experience working with FDA OPDP and APLB on advertising and promotion matters
Experience in CNS is a plus
Experience in Veeva PromoMats is a strong plus

Benefits

Comp & perks

100% paid health benefits including Medical, Dental and Vision for you and your dependents
401(k) program with company match and vesting after the turn of the first month after your start date
Flexible time off
Generous parental leave
Some fun fringe perks
Additional compensation, including bonus and equity, may be available