Job Responsibilities
- Provide commercial regulatory support for multiple high-volume brands/therapeutic areas and projects (as appropriate).
- Review and approve promotional materials; chair Promotional Review Committee (PRC) for complex/high-volume brands/therapeutic areas.
- Maintain awareness of FDA regulations, guidance, and enforcement for advertising/promotion.
- Serve as regulatory liaison to FDA/CDER/OPDP or FDA/CBER/APLB for assigned products.
- Lead (or support) local/global cross-functional process improvements or special projects.
- Provide regulatory guidance on new marketing concepts, messaging, campaigns, and product labeling.
- Advise stakeholders on regulatory impact of new campaign concepts and labeling, including pre-approval communications.
- Represent RA Ad/Promo at Regulatory Project Team meetings and labeling meetings.
- Ensure work complies with established practices, policies, processes, and regulatory requirements.
Basic Qualifications
- PharmD/PhD with 6+ years relevant experience.
OR
- MA/MS/MBA with 10+ years relevant experience.
OR
- BA/BS with 12+ years relevant experience, including 4+ years regulatory review of promotional materials for prescription drug or biologic products.
Preferred Qualifications
- Experience leading commercial regulatory/related strategy across multiple products; chairing promotional/regulatory governance committees.
- Track record directing strategy to successful conclusion; negotiation with regulatory authorities.
- Experience authoring/implementing processes; cross-functional leadership; managing large, complex, time-sensitive projects.
- Expert knowledge of U.S. regulatory requirements; regulatory/business analytical skills.
- Ability to rapidly learn therapeutic areas; strong communication, negotiation, conflict resolution, coaching; when needed, travel.
Compensation/Benefits (as stated)
- Salary range: $210,375.00β$272,250.00. May include discretionary bonus/long-term incentives, paid time off, and company-sponsored medical/dental/vision/life insurance.
Application Instructions
- Please apply via the Internal Career Opportunities portal in Workday.