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Ascendis Pharma · 4 days ago

Regulatory Affairs, Advertising and Promotion Professional - Job ID: 1690

Princeton, NJ

Full-time

Onsite

Mid, Senior Level

$185K/yr - $200K/yr

7+ years exp

Ascendis Pharma is dedicated to improving patients’ lives through innovative products and processes. The Regulatory Affairs, Advertising and Promotion Professional will serve as an internal expert on U.S. FDA regulations and provide commercial regulatory strategy to ensure compliance while meeting business needs.

BiotechnologyClinical TrialsHealth Care

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

Qualification

Regulatory AffairsFDA regulationsPromotional materials reviewLife science degreeEDMS experienceOralLeadership skillsWritten skillsCollaboration skills

Required

Degree in life science or equivalent

7-10+ years' experience in drug, biologic and/or combination products in Regulatory Affairs or related field

Minimum of 5 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

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

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

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

Maintain current knowledge of applicable government regulations, particularly those related to advertising and promotion

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

Requires up to 20% travel