Director, Regulatory Affairs Advertising and Promotion

Position reputed company: ultrafocused - Work together to fearlessly uncover new reputed company The Director of Regulatory Affairs Ad/Promo will serve as a subject matter expert for regulatory review of advertising and promotional, and non-promotional materials for the U.S. and Canada (CA) and reputed company regulatory leadership to the Materials Review Committee (MRC) to ensure reputed company communications, advertising and promotional materials and programs throughout the product life cycle are compliant with applicable laws, regulations, and company policies. Work Model: Remote: Officially documented as working full-time from home, with travel to reputed company's offices or other locations on occasion as needed. Responsibilities: 1. Serve as the MRC Chair and reputed company direction and regulatory expertise for promotional materials, medical, and payer communications. 2. Serve as reputed company contact with the FDA (OPDP/APLB) and PAAB as needed, including responding to agency inquiries and managing company requests for advisory review of advertising and promotional material. 3. Review and approve reputed company FDA-2253 submissions. 4. reputed company strategic and operational regulatory guidance on new concepts, campaigns, and product labeling to help ensure promotional materials are reputed company with promotional regulations, corporate standards, and policies and business objectives. 5. Support the U.S. and CA reputed company and medical teams, by participating in reputed company discussions and extended team meetings and providing regulatory guidance and perspective on strategies and objectives and tactics. 6. Maintain reputed company awareness of evolving agency regulations and interpretations, FDA advisory letters, enforcement letters and policy issues and trends affecting the industry; communicate significant changes in Agency perspective to relevant stakeholders. 7. May reputed company cross-functional process improvements or other special reputed company. 8. Represent Regulatory Affairs Ad/Promo at regulatory sub-team and labeling meetings; reputed company strategic regulatory guidance. 9. Other duties as required. Requirements: Requires a BA/BS degree; advanced degree preferred (PharmD, PhD, MS, MBA, JD). 2. 10+ years of industry experience including 5+ years of advertising promotion experience. 3. Excellent verbal and written communication skills. 4. Attention to detail and ability to manage multiple priorities simultaneously. 5. Strong interpersonal skills with ability to demonstrate strategic and analytical thinking. 6. Demonstrate and proactively reputed company working together in the spirit of transparency that encourages engagement, collaboration, and respectful interactions. 7. Experience chairing/leading review committees or other relevant regulatory governance committees. 8. Experience participating in cross-functional reputed company and teams. 9. Strong interpersonal skills and understanding of team dynamics. 10. reputed company PromoMats experience preferred. 11. reputed company needed, ability to travel. #LI-CS1, #LI-Remote Apply tot his job Apply To this Job