Regulatory Ad Promo Associate Director

Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit  neurocrine.com , and follow the company on  LinkedIn ,  X , Facebook and YouTube . ( *in collaboration with AbbVie ) About the Role: Serves as the lead reviewer for medical education and commercial advertising and promotional materials for product, disease state, and training/education programs. Leads cross-functional collaboration to ensure appropriate reviews take place and timely submissions are made to OPDP. Work closely with the Director, Regulatory Ad Promo to formulate the strategic direction and develop process improvements for the Regulatory Ad/Promotion function.Proactively reviews regulatory promotional guidelines and untitled/warning letters; assesses phase IV clinical trial design with regard to possibilities for use in proactive or reactive marketing or medical communication. Assesses labeling changes for potential impact on Ad/Promo and and medical communications materials. _ Your Contributions (include, but are not limited to): Assumes a leadership role in the PRC Process for assigned products to ensure compliance with FDA advertising and promotional regulations and guidelines for select product, disease state, and all medical education materials Responsible for timely and accurate review, and timely submission of promotional materials (i.e. FDA 2253 submissions) Independently represents Regulatory Affairs on the Medical Review Committee (MRC) and be responsible for conducting the regulatory review of materials for assigned products/programs intended for use by the field medical team Track and evaluate FDA guidance, policies and the overall regulatory environment and must be able to assess and communicate potential risk and impact to Sr. Leadership Develop and maintain a business partnership environment between Regulatory Affairs, PRC and MRC partner functions in the review and approval of advertising and promotional materials Actively manages communications to Regulatory management, and ensures promotional claims are in compliance with terms of approved product registrations, current labeling, applicable laws, internal policies and external regulations Proactively assesses advertising and promotion-related processes and procedures to enhance efficiencies and compliance Identify and recommend/implement policy and/or process changes as needed in partnership with Director, Regulatory Ad/Promo Maintain standard operating procedures and department working practices Mentors and develops junior level team members Other duties as assigned Requirements: BS/BA degree in Life/Health Sciences or related field AND 10+ year's of Regulatory Affairs experience at a biotech, pharmaceutical or device company, including significant experience in Advertising & Promotion process management. OR Master’s degree in Life/Health Science or related field AND 8+ years of similar experience as noted above Emerging as an internal thought leader with technical and/or business expertise Applies