Assoc. Director, Regulatory Affairs Advertising and Promotion

Guided by the recognition that patients deserve more than better, Definium is relentlessly advancing a new generation of therapeutics intended to address the underlying causes of psychiatric and neurological disorders. The Associate 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 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. 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 matters Experience in Veeva Promomats a strong plus The Company provides competitive benefits to employees including: