Director, Regulatory Affairs – Advertising and Promotions

🔥 20 minutes ago

🇺🇸 United States – Remote

💵 $215k - $255k / year

⏰ Full Time

🔴 Lead

🚔 Compliance

👻 Ghost score 3%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Definium Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2019

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Definium Therapeutics is a clinical-stage biotechnology company developing precision psychedelic-derived therapeutics for psychiatric and neurodevelopmental disorders. The company focuses on pharmaceutically optimized formulations of lysergide (LSD) and an R-enantiomer of MDMA to treat conditions such as major depressive disorder, generalized anxiety disorder, and core symptoms of autism spectrum disorder, advancing candidates through preclinical and clinical trials with a science-led, evidence-backed approach.

📋 Description

• 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

• 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

• 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