Title: Associate Director Regulatory Affairs Advertising and Promotion
Summary:
A leading pharmaceutical company is looking to add an Associate Director of Regulatory Affairs Advertising and Promotion to their growing team! The ideal candidate will be a seasoned Ad Promo professional who will be responsible for providing strategic advice, regulatory review, and working on products from early stages through commercialization.
Responsibilities:
- Act as subject matter expert on FDA regulations and OPDP guidance regarding promotion and prescription drug/ biologic products and disease awareness
- Provides regulatory strategic oversight for complex products or therapeutic space to help ensure regulatory compliance of promotional and non-promotional materials assigned,
- Knowledge and management of Form 2253 submissions
- Maintain understanding on relevant US Prescribing Information (USPI) and ensure all changes are adhered to
- Providing training as need to personnel on promotion, marketing, and labeling regulations
Qualifications:
- 7+ years of Regulatory Advertising & Promotion experience
- Preferred background in rare disease and/or autoimmune space
- Strong interpersonal and communication skills with a team player attitude
