Associate Director, Regulatory Affairs, Advertising and Promotion - Job ID : 1690

Overview

At Ascendis, we strive to make meaningful improvements in patients’ lives. We make business decisions on patients’ 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 Associate Director 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 Associate Director Regulatory Affairs, Advertising and Promotion is responsible for providing commercial regulatory strategy 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. This position will work out of our Princeton, NJ and will primarily support stakeholders working East Coast hours.

Key Responsibilities

• Independently 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 appropriate 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.
• Advise cross-functional stakeholders on the commercial regulatory impact of new campaign concepts, target, or product labeling, and providing 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.
• Provides commercial regulatory support to high-volume brands or therapeutic areas and projects without managerial oversight, as appropriate.
• Operates independently, with recognition of when to consult departmental senior leadership to identify and escalate risks.
• Design and deliver targeted trainings for cross-functional brand teams and senior leaders on U.S. ad promo regulations (e.g., OPDP expectations), emerging guidances, and enforcement trends; proactively identify and close knowledge gaps.

Qualifications

The estimated salary range for this position is $185-200k / year. Actual salary determination is dependent on a variety of factors some of which include : experience, qualifications, and geographic location. This position may be eligible for a discretionary annual bonus or an incentive compensation plan (eligibility varies based on role and position level), discretionary stock-based long-term incentives, paid time off, and a comprehensive benefits package.

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