Director, Regulatory Affairs (Advertising and Promotions)

Definium Therapeutics

2d • $215,000 - $255,000

About The Position

Definium Therapeutics is a late-stage clinical biopharmaceutical company focused on developing accessible treatments for psychiatric and neurological disorders using psychedelics. Our lead candidate targets anxiety, depression, and PTSD, with another in development for autism spectrum disorder. We are seeking an experienced promotional reviewer to join our Regulatory Affairs team. The Director, Regulatory Affairs (Advertising and Promotion) will be responsible for the review and approval of US promotional materials, medical communications, and social media for assigned brands. This role will provide regulatory guidance on promotional and advertising campaigns for both marketed products and development programs. Additionally, the position will contribute to labeling strategies and lead interactions with the FDA's Office of Prescription Drug Promotion (OPDP) and Advertising and Promotion Labeling Branch (APLB). The incumbent will manage all submission types to OPDP/APLB, ensuring compliance with regulatory standards through leadership in the Medical, Legal, Regulatory (MLR) review process. This role requires close collaboration with Commercial, Medical Affairs, and Legal departments to provide regulatory advice throughout the promotional plan development lifecycle, ensuring adherence to FDA requirements, PhRMA DTC Guidelines, and company policies.

Requirements

• Minimum BS in scientific discipline, advanced degree in science preferred
• Minimum 10 years’ experience in the pharmaceutical industry
• At least 5 years as a regulatory advertising and promotional reviewer
• Expert knowledge of advertising promotion regulations and FDA Guidance documents issued
• Some technical experience in aspects of drug development and labeling
• Solid experience with promotional and medical review supporting product communications
• Experience working with FDA (OPDP, APLB) on advertising and promotional matters

Nice To Haves

• Experience in CNS is a plus
• Experience in Veeva PromoMats a strong plus

Responsibilities

• Serve as the internal subject matter expert on FDA Advertising & Promotion matters for assigned product(s) providing regulatory advice and offering solutions to reconcile regulatory comments on draft promotional materials to maintain compliance with FDA regulations
• Review and approval of promotional and medical materials in Definium’s PromoMats system
• Represent the regulatory perspective in live MLR meetings and concept reviews
• Review and approval of social media posts
• Liaise with OPDP/APLB (FDA) as needed for assigned product(s) serving as our company's single point of contact with FDA on matters related to advertising and promotional materials
• Manage interactions with OPDP/APLB, including response to regulatory inquiries, preparation of complete, accurate, high-quality submissions for advisory comments, and as needed discussion with OPDP/APLB staff
• Ensure timely and accurate FDA 2253 submissions of US promotional materials
• Ensure that changes and updates in prescribing information are reflected in current promotional and advertising materials
• Aid in the development of processes and standards for promotional materials and related activities to facilitate streamlined workflows and encourage an efficient review process
• Provide regulatory training as needed on FDA requirements, PhRMA DTC Guidelines and Company policy with respect to best practices in compliance with company policies and guidelines for PRC processes

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!

What This Job Offers

• Job Type: Full-time
• Career Level: Director