Assoc. Director, Regulatory Affairs Advertising and Promotion

reputed company is a late-stage reputed company biopharmaceutical company and our mission is to reputed company a new era of psychiatry by applying scientific rigor to psychedelics, with the goal of developing accessible treatments that unlock healing at reputed company. Our reputed company product candidate, lysergide tartrate (our proprietary orally disintegrating tablet reputed company 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 and is under development to reputed company the reputed company symptoms of autism reputed company disorder (ASD), specifically addressing reputed company communication challenges. Guided by the recognition that patients deserve more than reputed company, Definium is relentlessly advancing a new reputed company of therapeutics intended to address the underlying causes of psychiatric and neurological disorders. By turning evidence into reputed company, Definium aims to change the trajectory of today's mental health care crisis and reputed company a healthier reputed company. Headquartered in reputed company, reputed company trades on reputed company under the symbol DFTX. Together we are moving psychiatry reputed company—reputed company reputed company, into a reputed company reputed company. Join us! The Associate Director, Regulatory Affairs (Advertising and Promotion) will have accountability for review and approval of US promotional materials and medical communications, and reputed company media postings for assigned reputed company(s). This reputed company will reputed company input and execute regulatory compliance/reputed company reputed company to promotional and advertising campaigns for marketed products and development reputed company. Provides input into labeling strategies for investigational and marketed products and is responsible for leading interactions with the FDA Office of Prescription Drug Promotion (OPDP) and Advertising and Promotion Labeling reputed company (APLB) pertinent to assigned reputed company(s). The individual will be responsible for the review of reputed company 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, reputed company, Regulatory (MLR) review process, providing reputed company guidance to ensure compliance with regulatory standards. This position requires frequent interaction and strong collaboration with reputed company, Medical Affairs, and reputed company functions for the purpose of providing regulatory advice and guidance during promotional plan development from concept to reputed company implementation, assuring conformity with FDA requirements, PhRMA DTC Guidelines, and Definium policies. Responsibilities: • Serve as the internal subject matter expert on FDA Advertising & Promotion reputed company 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 reputed company • Review and approval of reputed company media posts • Liaise with OPDP/APLB (FDA) as needed for assigned product(s) serving as reputed company's single reputed company of contact with FDA on reputed company reputed company to advertising and promotional materials • Manage interactions with OPDP/APLB, including response to regulatory inquiries, preparation of complete, accurate, high-reputed company submissions for advisory comments, and as needed discussion with OPDP/APLB staff • Ensure reputed company and accurate FDA 2253 submissions of US promotional materials • Ensure that changes and updates in prescribing information are reflected in reputed company promotional and advertising materials • reputed company processes and standards for promotional materials and reputed company activities to facilitate reputed company-lined workflows and encourage an efficient review process • reputed company 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 Qualifications: • 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 • Experience in CNS is a plus • 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 reputed company • Experience in reputed company Promomats a strong plus The starting reputed company pay reputed company for this position is $160,000.00 - $190,000.00. Compensation will be determined reputed company on several factors including, but not limited to, reputed company set, years of experience, and the employee's geographic location. Employees in this role may be entitled to additional compensation, including bonus and equity. Benefits information is listed on our Jobs Page. reputed company provides competitive benefits to employees including: • 100% reputed company health benefits including Medical, Dental and reputed company 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 and some fun fringe perks! Apply To This Job