Assoc. Director, Regulatory Affairs Advertising and Promotion
Definium Therapeutics is a late-stage clinical biopharmaceutical company on a mission to forge a new era of psychiatry by applying scientific rigor to psychedelics. Our goal is to develop accessible treatments that unlock healing at scale. Our lead product candidate, lysergide tartrate (a proprietary orally disintegrating tablet form of lysergide (LSD) D-tartrate), represents a highly differentiated, potential best-in-class opportunity for patients suffering from generalized anxiety, major depressive disorder, and posttraumatic stress disorder. Our early-stage pipeline includes DT402, the R-enantiomer of MDMA, under development to target the core symptoms of autism spectrum disorder (ASD), specifically addressing social communication challenges. Guided by the recognition that patients deserve more than better, Definium is advancing a new generation of therapeutics intended to address the underlying causes of psychiatric and neurological disorders. Headquartered in New York, Definium Therapeutics trades on Nasdaq under the symbol DFTX.
About the role
The Associate Director, Regulatory Affairs (Advertising and Promotion) will have accountability for review and approval of US promotional materials, medical communications, and social media postings for assigned brand(s). This role provides input and executes regulatory compliance/strategy related to promotional and advertising campaigns for marketed products and development projects. The individual will lead interactions with the FDA Office of Prescription Drug Promotion (OPDP) and Advertising and Promotion Labeling Branch (APLB) pertinent to assigned brand(s), including submissions and responses to regulatory inquiries.
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 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 single point of contact 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 discussions 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 streamlined workflows and encourage an efficient review process.
- Provide regulatory training on FDA requirements, PhRMA DTC Guidelines, and Company policy with respect to best practices in compliance for PRC processes.
Requirements
- Minimum BS in a 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, 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.
- Experience in CNS is a plus.
- Experience in Veeva PromoMats is a strong plus.
Pay
The starting base pay range for this position is $160,000.00 - $190,000.00. Compensation will be determined based on skill set, years of experience, and geographic location. Employees in this role may be entitled to additional compensation, including bonus and equity.
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 first month of employment.
- Flexible time off.
- Generous parental leave.
- Additional fun fringe perks.