Director, Regulatory Affairs; Advertising and Promotions

Director, Regulatory Affairs (Advertising and Promotions)RemoteDefinium Therapeutics is a late-stage clinical biopharmaceutical company and our mission is to forge a new era of psychiatry by applying scientific rigor to psychedelics, with the goal of developing accessible treatments that unlock healing at scale.Our leadproductcandidate,lysergidetartrate(our proprietary orally disintegrating tablet form oflysergide(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 and is under development to target the core symptoms of autism spectrum disorder (ASD), specifically addressing social communication challenges.Guided bythe recognition that patients deserve more than better, Definium is relentlessly advancing a new generation of therapeutics intended to addresstheunderlying causes of psychiatric and neurological disorders. By turning evidence into impact, Definium aims to change the trajectory of today’s mental health care crisis and enable a healthier future. Headquartered in New York, Definium Therapeutics trades on Nasdaq under the symbol DFTX.Together we are moving psychiatry forward—beyond better, into a boundless future. Join us!Definium seeks an experienced promotional reviewer to join our Regulatory Affairs team. The Director, Regulatory Affairs (Advertising and Promotion) will have accountability for review and approval of US promotional materials and medical communications, and social media postings for assigned brand(s). This colleague will provide regulatory guidance related to promotional and advertising campaigns for marketed products and development programs. This role will also provide input into labeling strategies for marketed products and is responsible for leading interactions with the FDA Office of Prescription Drug Promotion (OPDP) and Advertising and Promotion Labeling Branch (APLB) pertinent to assigned brand(s). The individual will be responsible for the review of all submission types made to OPDP/APLB (FDA). The incumbent’s responsibilities include providing review of promotional and medical materials and functioning as a leader during the Medical, Legal, Regulatory (MLR) review process, providing clear guidance to ensure compliance with regulatory standards. This position requires frequent interaction and strong collaboration with Commercial, Medical Affairs, and Legal functions for the purpose of providing regulatory advice and guidance during promotional plan development from concept to field implementation, assuring conformity with FDA requirements, PhRMA DTC Guidelines, and Definium policies.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 regulationsReview and approval of promotional and medical materials in Definium’s Promo Mats systemRepresent the regulatory perspective in live MLR meetings and concept reviewsReview and approval of social media postsLiaise 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 materialsManage 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 staffEnsure timely and accurate FDA 2253 submissions of US promotional materialsEnsure that changes and…