Director, Regulatory Affairs – Advertising and Promotions

Definium Therapeutics

. Serve as the internal subject matter expert on FDA Advertising & Promotion matters for assigned products .

Posted 9/30/2026full-timeRemote • United StatesLead💰 $215,000 - $255,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expert knowledge of FDA Advertising and Promotion regulations, with extensive experience in reviewing promotional materials and managing regulatory interactions. Proficient in providing regulatory training and collaborating across departments to ensure compliance and effective communication.

Highest-signal resume keywords

FDA Advertising And Promotion RegulationsRegulatory Advertising And Promotional ReviewVeeva PromoMatsFDA OPDP And APLB InteractionRegulatory Training

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory AdvicePromotional Material ReviewMedical ReviewFDA 2253 SubmissionsDrug Development KnowledgeLabeling ExpertiseCNS Experience

Soft Skills

CollaborationCommunication

Tools & Technologies

Definium PromoMats

Industry Keywords

Pharmaceutical IndustryPhRMA DTC GuidelinesRegulatory Compliance

About the role

Key responsibilities & impact

Serve as the internal subject matter expert on FDA Advertising & Promotion matters for assigned products
Provide regulatory advice and solutions to reconcile regulatory comments on draft promotional materials
Review and approve promotional and medical materials in Definium’s PromoMats system
Represent the regulatory perspective in live MLR meetings and concept reviews
Review and approve social media posts
Liaise with OPDP/APLB (FDA) as the company’s point of contact on advertising and promotional matters
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
Aid development of processes and standards for promotional materials and related activities
Provide regulatory training on FDA requirements, PhRMA DTC Guidelines, company policy, and PRC processes
Collaborate with Commercial, Medical Affairs, and Legal from promotional concept through field implementation

Requirements

What you’ll need

Minimum BS in scientific discipline
Minimum 10 years’ experience in the pharmaceutical industry
At least 5 years as a regulatory advertising and promotional reviewer
Experience in CNS is a plus
Expert knowledge of advertising promotion regulations and FDA Guidance documents
Technical experience in aspects of drug development and labeling
Solid experience with promotional and medical review supporting product communications
Experience working with FDA OPDP and APLB on advertising and promotional matters
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 may include bonus and equity