Associate Director, Regulatory Affairs – Advertising and Promotion

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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 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

• 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

• 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