Director, Commercial Regulatory Affairs

Recruiter
Ipsen
Location
Cambridge, UK
Salary
Competitive
Posted
09 Oct 2019
Closes
19 Oct 2019
Ref
1271055269
Sector
Legal
Contract Type
Permanent
Hours
Full Time
Title:Director, Commercial Regulatory AffairsCompany:Ipsen Biopharmaceuticals Inc.Job Description:The Director, Commercial Regulatory Affairs will have accountability for review of promotion and medical communications for assigned brands, Ipsen products first use submissions and reports on postmarket requirements made to FDA. This individual is responsible for leading interactions pertinent to assigned brands with the FDA Office of Product and Drug Promotion. The incumbent's responsibility includes contributing in a leadership capacity to the evolution of the Promotional Review Committee process to ensure business needs are met efficiently and effectively and Ipsen communications are compliant. The position requires interaction with Global Regulatory Affairs, US Medical Affairs, US Legal Affairs, Compliance and Commercial functions for the purpose of providing regulatory insight during promotional plan development and implementation to ensure conformity with FDA requirements.ResponsibilitiesResponsibilities will include, but are not limited to, the following:Serve as the internal subject matter expert on FDA Advertising & Promotion issues and provide internal training as needed on FDA requirementsLiaise with FDA/OPDP as needed for assigned productsLead the Promotional Review Committee (PRC) Process for assigned products providing guidance to maintain compliance with FDA advertising and promotional regulations, pertinent laws and company policyFoster a business partnership environment between Regulatory and PRC partner functions in the review and approval of Ipsen advertising and promotional materialsCollaborate with Global Regulatory Affairs to align strategy to US Commercial Teams' strategic imperativesDevelop SOPs and working instructions to facilitate consistent high performing commercial regulatory operations and efficient promotional review processLead PRC teams in management of: re-review and expiry of approved materials and implementation of revised product labels in promotional materials, revised promotional content, safety information and requisite training materials for repsEducationBS or MS in scientific discipline; advanced scientific degree preferredExperienceAdvanced and/or bachelor's degree in a scientific discipline with a minimum of 10 years of experience in the biotech/pharmaceutical industry and a minimum of 7 years in regulatory affairsExperience in Rare Disease preferred. Endocrinology, Neurology, and Oncology a plus Expert current knowledge of post-marketing regulations with some technical experience in aspects of drug development and labelingSolid experience with promotional review and working with FDA (OPDP, APLB) on advertising and promotion issues for assigned productsOversee OPDP submissions process and author all submissions for assigned productsCore CompetenciesAbility to understand and interpret clinical data. Expert understanding of FDA promotional regulations and reports on postmarketing requirementsExcellent oral and written communication and negotiation skills with strong attention to detail and clarityAbility to interact effectively and influence across relevant functions within Ipsen and with regulatorsDemonstrate understanding of commercial objectives of the company and how outcomes can be delivered while meeting FDA compliance standardsBe an innovator of new ideas and best practicesMust anticipate and solve problemsRecognized as a leader, team player, and possess a cross-functional collaborative skill setAbility to manage multiple activities or projectsIPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.Full time

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