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<ul> <li> 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</li> <li>Collaborate with Medical, Legal, Commercial, and Compliance to execute and approve key Commercial campaigns. Provides appropriate guidance to help evaluate and mitigate potential risk.</li> <li>Present to senior management and cross-functional teams regarding shared learnings from FDA advisory comments, recent enforcement actions, and/or guidance documents.</li> <li>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</li> <li>Serve as the companys 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.</li> <li>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.</li> <li>Provides commercial regulatory support to high-volume brands or therapeutic areas and projects without managerial oversight, as appropriate.</li> <li>Operates independently, with recognition of when to consult departmental senior leadership to identify and escalate risks. </li> <li>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.</li> </ul><ul> <li>Degree in life science or equivalent. Advanced degree (PharmD, PhD, MS, MBA, JD) preferred.</li> <li>Minimum of 8 years’ experience in drug, biologic and/or combination products in Regulatory Affairs or related field.</li> <li>Minimum of 5 years of experience in Regulatory Affairs promotion and advertising working with prescription drug, biologic, and/or combination products.</li> <li>Experience managing major regulatory filing(s) to the FDA Office of Prescription Drug Promotion (e.g., launch advisory comment submission or responses to enforcement letters) or competitor complaints. Launch experience is a plus. </li> <li>Proven experience serving as the independent regulatory reviewer for promotional materials of a drug or biologic with extensive market visibility and a high volume of promotional activity</li> <li>Proven ability to navigate labeling negotiations with the FDA while collaborating closely with internal regulatory colleagues and cross-functional partners to align on strategy and execution</li> <li>Demonstrated skill in evaluating potential regulatory risk within promotional materials and effectively communicating those risks in a clear, actionable manner to PRC stakeholders and cross-functional marketing partners</li> <li>Maintain current knowledge of applicable government regulations, particularly those related to advertising and promotion. Knowledge of historical enforcement actions and can use this when offering recommendations to stakeholders.</li> <li>Demonstrated leadership skills. Ability to manage and bring working teams together for common objectives.</li> <li>Excellent oral and written skills, timeline responsibilities.</li> <li>Prior experience with an EDMS required, preferably Veeva Promomats and RIM.</li> <li>Ability to travel to various meetings including overnight trips. Some international travel may be required.</li> <li>Requires up to 20% travel.</li> </ul>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.

Ascendis Pharma

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

Ascendis Pharma