Director, Commercial Regulatory Affairs

Location
Cambridge, MA, United States
Posted
Sep 20, 2019
Ref
R-03890
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
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 Committeeprocess 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.

Responsibilities

Responsibilities 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 requirements
  • Liaise with FDA/OPDP as needed for assigned products
  • Lead the Promotional Review Committee (PRC) Process for assigned products providing guidance to maintain compliance with FDA advertising and promotional regulations, pertinent laws and company policy
  • Foster a business partnership environment between Regulatory and PRC partner functions in the review and approval of Ipsen advertising and promotional materials
  • Collaborate with Global Regulatory Affairs to align strategy to US Commercial Teams' strategic imperatives
  • Develop SOPs and working instructions to facilitate consistent high performing commercial regulatory operations and efficient promotional review process
  • Lead 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 reps


Education

BS or MS in scientific discipline; advanced scientific degree preferred

Experience
  • Advanced 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 affairs
  • Experience 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 labeling
  • Solid experience with promotional review and working with FDA (OPDP, APLB) on advertising and promotion issues for assigned products
  • Oversee OPDP submissions process and author all submissions for assigned products


Core Competencies
  • Ability to understand and interpret clinical data. Expert understanding of FDA promotional regulations and reports on postmarketing requirements
  • Excellent oral and written communication and negotiation skills with strong attention to detail and clarity
  • Ability to interact effectively and influence across relevant functions within Ipsen and with regulators
  • Demonstrate understanding of commercial objectives of the company and how outcomes can be delivered while meeting FDA compliance standards
  • Be an innovator of new ideas and best practices
  • Must anticipate and solve problems
  • Recognized as a leader, team player, and possess a cross-functional collaborative skill set
  • Ability to manage multiple activities or projects


IPSEN 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.