Director - Regulatory Affairs Advertising & Promotions

The Director, Regulatory Affairs - Advertising & Promotion will provide strategic regulatory advice on advertising and promotion for assigned products in accordance with business goals and objectives, FDA regulations and guidance, and company policies.

Responsibilities:
- Provide strategic guidance for responsible products and disease states based on current regulatory environment and competitive landscape
- Assess risk and advise on mitigation strategies to meet business need while maintaining compliance with US regulatory requirements and company procedures
- Maintain up-to-date knowledge of federal and state laws, regulations, and policies related to advertising and promotion of pharmaceuticals and devices
- Apply regulatory and therapeutic area knowledge to Brand Team objectives to resolve promotional issues while ensuring regulatory compliance and managing business risks
- Advise on development of product messages and materials across functional areas; propose regulatory strategy for challenging promotional concepts
- Provide training in FDA regulations for advertising and promotion to employees and agents
- Collaborate with Regulatory Affairs colleagues on feasibility of promoting potential data/claims (study designs/US labels)
- Assist in US labeling negotiations; ensure changes in US Prescribing Information are reflected in promotion/advertising
- Support pre-launch and launch activities, including development of launch materials/new claims with Commercial, Medical, and Legal
- Advise on strategies to maintain an efficient, compliant Promotional Review Board (PRB) process
- Serve as a primary regulatory advertising and promotion reviewer for assigned products
- Liaison with OPDP; oversee preparation/submission of draft introductory materials for advisory comment
- Ensure FDA compliance, including timely and accurate OPDP submissions with FDA Form 2253

Qualifications:
- Bachelor’s degree in a health- or science-related field and/or an advanced degree
- Minimum 11 years of pharmaceutical/biologics industry experience; 6 years of promotional review experience preferred
- Experience with promotion of a product with conditional approval (Subpart H) highly preferred
- Ability to build sound working relationships across different skill levels/backgrounds
- Excellent communication and leadership skills
- Ability to communicate business issues across all organizational levels, negotiate decisions, evaluate risk, and work toward solutions
- Experience and knowledge of current FDA requirements; experience handling interactions with FDA

Benefits (as stated):
- Medical, dental, and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement; voluntary benefits (e.g., group legal, critical illness, identity theft protection, pet insurance, auto/home insurance); time off (sick time policy, flexible vacation) and parental leave

Application instruction (as stated):
- For accommodation requests only, call 1-855-411-5290.