What are the responsibilities and job description for the Senior Manager, Regulatory Affairs, Advertising and Promotion position at Ascendis Pharma?
At Ascendis, we strive to make meaningful improvements in patients’ lives. We make business decisions on patient’s needs and we do our best every day to realize our products’ benefits for our patients. We are driven by patients, science, and data. We are dedicated to being curious and diligent when innovating, developing, and improving products and processes. We are passionate about realizing our shared vision and goals. We trust each other’s strengths, and when we face challenges, we remain optimistic and committed to working together as one team to achieve extraordinary results.
The Sr. Manager Regulatory Affairs, Advertising and Promotion will be an internal expert on U.S. FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products.
The Sr. Manager Regulatory Affairs, Advertising and Promotion is responsible for providing commercial regulatory strategy and leadership to enable the US business to meet its commercial needs in a compliant manner.
As part of the Regulatory Affairs team, you will report to the Senior Director Regulatory Affairs, Advertising and Promotion. There is a preference for this position to work out of our Princeton, NJ. This position will primarily support stakeholders working East Coast hours.
- Review / approve promotional, medical, payor, corporate, and other non-promotional materials to assess for regulatory compliance with the applicable regulations, guidance documents, and internal policies / best practices
- Collaborate with Medical, Legal, Commercial, and Compliance to execute and approve key Commercial campaigns. Provides expert guidance to help evaluate and mitigate potential risk.
- Present to senior management and cross-functional teams regarding shared learnings from FDA advisory comments, recent enforcement actions, and / or guidance documents.
- Assumes a leadership role in advising cross-functional stakeholders on the commercial regulatory impact of new campaign concepts, target, or product labeling, and to provide strategic regulatory guidance on corporate communications and appropriate pre-approval and / or disease education communications
- Serve as the company's regulatory liaison to the FDA’s Advertising and Promotional Labeling Branch and Office of Prescription Drug Promotion for respective product(s) and will ensure materials are submitted to FDA via 2253.
- Support metrics to measure and track the effectiveness and efficiency of the promotional review process and provide recommendations for process improvements to address potential issues.
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