Associate Director, Regulatory Affairs Advertising & Promotion Compliance
Skills
- Comprehensive knowledge of FDA regulations and guidance for prescription drug advertising and promotion
- Understanding of clinical study design and statistical analysis for claim assessment
- Ability to interpret and apply regulatory requirements to promotional materials
- Strong interpersonal and communication skills
- Ability to work accurately under tight deadlines and complex situations
- Strategic thinking and leadership capabilities
Responsibilities
- Review, approve, and monitor promotional and advertising labeling to ensure FDA regulatory compliance
- Provide strategic regulatory support and guidance for promotional and non-promotional communications
- Serve as chair of the Promotional Review Committee and primary regulatory reviewer for assigned products
- Collaborate with Legal, Medical, and cross-functional teams on promotional materials and compliance
- Oversee Medical Review Process for assigned products
- Ensure promotional materials reflect current US Prescribing Information changes
- Maintain regulatory records and manage communications with FDA's OPDP
- Monitor regulatory environment and communicate changes internally
- Develop and update policies related to promotional compliance
- Provide regulatory compliance training to staff and partners
Education
- Advanced degree preferred (Pharm.D., PhD, MS, JD)
- Minimum of 8 years’ experience with Bachelor’s degree or 5 years with advanced degree in Advertising and Promotion regulatory review
Benefits
- 401K with company matching
- Discretionary Profit Sharing and Annual Bonus Program
- Generous PTO including Summer and Winter Shut-Downs, Sick and Volunteer Days
- Comprehensive Healthcare Benefits: Medical, Dental, Vision, Prescription Drugs
- HSA & FSA Programs
- Well-being and Work/Life programs
- Long-Term Incentives
- Life & Disability Insurance
- Concierge Service
- Pet Insurance
- Tuition Assistance
- Employee Referral Awards
Average salary estimate
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