Assoc. Director, Regulatory Affairs Advertising and Promotion

Definium Therapeutics

6d • $160,000 - $190,000

About The Position

Definium Therapeutics is a late-stage clinical biopharmaceutical company focused on developing accessible treatments for psychiatric and neurological disorders. Our lead product candidate targets anxiety, depression, and PTSD, with other pipeline candidates addressing autism spectrum disorder. We are dedicated to advancing a new generation of therapeutics to address the underlying causes of these conditions and transform mental health care. Headquartered in New York and trading on Nasdaq, we are moving psychiatry forward into a boundless future.

The Associate Director, Regulatory Affairs (Advertising and Promotion) will be responsible for the review and approval of US promotional materials, medical communications, and social media content for assigned brands. This role involves providing regulatory compliance and strategy input for promotional and advertising campaigns for both marketed products and development projects. The position also includes providing input into labeling strategies and leading interactions with the FDA's Office of Prescription Drug Promotion (OPDP) and Advertising and Promotion Labeling Branch (APLB). The incumbent will review all submission types to OPDP/APLB, function as a leader in the Medical, Legal, Regulatory (MLR) review process, and provide clear guidance to ensure compliance with regulatory standards. This role requires frequent interaction and collaboration with Commercial, Medical Affairs, and Legal teams to offer regulatory advice and guidance throughout the promotional plan development process, ensuring conformity with FDA requirements, PhRMA DTC Guidelines, and company policies.

Requirements

• Minimum BS in scientific discipline, advanced degree in science preferred
• Minimum 8 years’ experience in the pharmaceutical industry with at least 5 years in regulatory affairs
• Expert knowledge of advertising promotion regulations and FDA Guidance documents issued with some technical experience in aspects of drug development and labeling
• Solid experience with promotional and medical review supporting product communications and working with FDA (OPDP, APLB) on advertising and promotion 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
• 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
• Develop processes and standards for promotional materials and related activities to facilitate stream-lined 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: Manager