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 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.
Key Responsibilities: 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. Minimum Qualifications: Degree in life science or equivalent. Advanced degree (PharmD, PhD, MS, MBA, JD) preferred. You have a minimum of 8 years of experience in drug, biologic and/or combination products in Regulatory Affairs or related field. Minimum of 8 years of experience in Regulatory Affairs promotion and advertising working with prescription drug, biologic, and/or combination products; 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. Understand the phases, processes and techniques used within a clinical development environment, can contribute to clinical study design discussions. 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. Extensive experience within relevant Therapeutic Area. Extensive experience in managing complex negotiations with internal as well as external stakeholders. Demonstrated leadership skills. Ability to manage and bring working teams together for common objectives. Excellent oral and written skills, timeline responsibilities. Prior experience with an EDMS required, preferably Veeva Promomats and RIM. Ability to travel to various meetings including overnight trips. Some international travel may be required. Requires up to 20% travel. Benefits: 401(k) plan with company match. Medical, dental, and vision plans. Company-offered Life and Accidental Death & Dismemberment (AD&D) insurance. Company-provided short and long-term disability benefits. Unique offerings of Pet Insurance and Legal Insurance. Employee Assistance Program. Employee Discounts. Professional Development. Health Saving Account (HSA). Flexible Spending Accounts. Various incentive compensation plans. Accident, Critical Illness, and Hospital Indemnity Insurance. Mental Health resources. Paid leave benefits for new parents.
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