Manager, Regulatory Affairs - Advertising and Promotion
Supernus Pharmaceuticals, Rockville, MD, United States
Manager, Regulatory Affairs - Advertising and Promotion
Supernus Pharmaceuticals is an award-winning biopharmaceutical company with more than 30 years of experience in developing and commercializing products that treat central nervous system (CNS) diseases. At Supernus, we develop innovative products that help treat neurological and psychiatric conditions. We currently have 8 products in the market that are making a real impact on patient outcomes. The Manager of Regulatory Affairs, Advertising and Promotion, is responsible for representing the Regulatory Affairs department at Promotional and Medical Review Committee meetings ensuring alignment with promotional strategies and regulatory expectations. This role functions as the subject matter expert on Food and Drug Administration (FDA) laws and regulations regarding the marketing of Supernus's pharmaceutical and medical products. Incumbents in this role will be responsible for reviewing marketing materials, collaborating with cross-functional teams, and providing regulatory guidance to minimize risk, and ensure accurate product messaging. Essential Duties & Responsibilities: Conducts regulatory review of advertising and promotional materials for assigned products and disease states. Serves as the Regulatory Affairs department representative on the Promotional and Medical Review Committees. Provides oversight of submission of promotional materials to the FDA's Office of Prescription Drug Promotion (OPDP) and Advertising and Promotional Labeling Branch (APLB). Serves as the subject matter expert for Regulatory Affairs to the marketing and sales departments. Assists with postmarketing supplements to marketed product applications. Implements labeling changes by preparing Important Safety Information and Brief Summary documents. Performs regulatory intelligence by monitoring OPDP and APLB enforcement, regulation changes and issuance of new guidance documents. Educates and trains cross-functional departments on prescription drug advertising regulations and labeling regulations. Department representative on selected project teams for commercial product launches and completion of post-marketing commitments. Interfaces with licensees regarding ex-US sales and promotion of commercial products. Other duties as assigned. Supernus Pharmaceuticals is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, disability, protected veteran status, age or any other characteristic protected by law.
Supernus Pharmaceuticals is an award-winning biopharmaceutical company with more than 30 years of experience in developing and commercializing products that treat central nervous system (CNS) diseases. At Supernus, we develop innovative products that help treat neurological and psychiatric conditions. We currently have 8 products in the market that are making a real impact on patient outcomes. The Manager of Regulatory Affairs, Advertising and Promotion, is responsible for representing the Regulatory Affairs department at Promotional and Medical Review Committee meetings ensuring alignment with promotional strategies and regulatory expectations. This role functions as the subject matter expert on Food and Drug Administration (FDA) laws and regulations regarding the marketing of Supernus's pharmaceutical and medical products. Incumbents in this role will be responsible for reviewing marketing materials, collaborating with cross-functional teams, and providing regulatory guidance to minimize risk, and ensure accurate product messaging. Essential Duties & Responsibilities: Conducts regulatory review of advertising and promotional materials for assigned products and disease states. Serves as the Regulatory Affairs department representative on the Promotional and Medical Review Committees. Provides oversight of submission of promotional materials to the FDA's Office of Prescription Drug Promotion (OPDP) and Advertising and Promotional Labeling Branch (APLB). Serves as the subject matter expert for Regulatory Affairs to the marketing and sales departments. Assists with postmarketing supplements to marketed product applications. Implements labeling changes by preparing Important Safety Information and Brief Summary documents. Performs regulatory intelligence by monitoring OPDP and APLB enforcement, regulation changes and issuance of new guidance documents. Educates and trains cross-functional departments on prescription drug advertising regulations and labeling regulations. Department representative on selected project teams for commercial product launches and completion of post-marketing commitments. Interfaces with licensees regarding ex-US sales and promotion of commercial products. Other duties as assigned. Supernus Pharmaceuticals is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, disability, protected veteran status, age or any other characteristic protected by law.