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Responsibilities
- Review and approve promotional, corporate, and non-promotional materials
- Represent commercial regulatory perspective at meetings and provide training
- Review and interpret enforcement letters and industry changes
- Provide strategic regulatory guidance on corporate and pre-approval communications
- Serve as liaison to FDA’s Office of Prescription Drug Promotion
- Ensure timely submission of materials to FDA
- Perform other duties as assigned
Requirements
- Bachelor’s Degree in related discipline; advanced degree preferred
- 9 years of regulatory affairs experience in pharma or biotech
- 5 years in regulatory affairs Ad/Promo preferred
- Experience in oncology, rare disease, or relevant therapeutic areas
- Direct experience with FDA’s Office of Prescription Drug Promotion preferred
- Proven ability to lead and influence data-driven strategy
- Strong leadership, communication, and interpersonal skills
- Ability to travel occasionally for business needs
Benefits
- Salary range: $167,375 – $220,000; actual pay based on experience and qualifications
- Discretionary annual bonus based on individual and Company performance
- Competitive compensation with equity grants
- 401K matching
- Fully covered medical, dental, and vision plans
- Full week of holiday break at year end
- Comprehensive benefits package for team members and families
