Senior Director, US Commercial Regulatory Affairs

Location
Cambridge, MA, United States
Posted
Oct 31, 2018
Ref
R-01284
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
Title:
Senior Director, US Commercial Regulatory Affairs

Company:
Ipsen Biopharmaceuticals Inc.

Job Description:

Position Summary

The Senior Director, Commercial Regulatory Affairs will have oversight of all post-marketing regulatory activities to support Ipsen's marketed products in the US and for leading the team involved in such activities. The incumbent's primary responsibility is to ensure efficient and compliant functioning of all promotional review for Ipsen's marketed products, and to ensure all post-marketing regulatory reporting requirements are completed and filed on time. S/he is responsible for managing and evolving the Promotional Review Committee process to ensure that the business needs are met efficiently and effectively. 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. This individual is responsible for leading all interactions with the FDA Office of Product and Drug Promotion. Finally, this role works with cross-functional areas to determine the appropriate strategy for labels for regulatory authority review and approval and, after approval, for maintaining labeling documents (implementing into packaging, promotion and posting on DailyMed).

Responsibilities

Responsibilities will include, but are not limited to, the following:
  • Lead and foster Ipsen's relationship with the FDA's Office of Prescription Drug Promotion (OPDP) and Advertising, Promotion and Labeling Branch (APLB). Liaise with FDA as needed on promotional issues
  • Serve as the internal subject matter expert on FDA Advertising & Promotion issues and provide internal training as needed on FDA requirements
  • Lead the Promotional Review Committee (PRC) Process and compliance with FDA advertising and promotional regulations, including submission of 2253 submissions
  • Foster a business partnership environment between Regulatory and PRC partner functions in the review and approval of Ipsen advertising and promotional materials
  • Lead and manage a team of direct reports. Train, coach, and mentor staff at all levels within the department
  • Collaborate with Global Regulatory Affairs on Regulatory strategies and communicates strategy to US Commercial Teams
  • Manage the Prescription Drug User Fee Act (PDUFA) Product Program Licensing and Establishment fees with FDA
  • In conjunction with Global Regulatory Affairs (GRA), coordinate the compilation and review of all Post-Marketing Annual Reports and ensures all post-marketing FDA requirements are met for all US marketed products
  • Manage the development of Structured Product Labeling (SPL), including Establishment and Drug Listings, and implementation of labeling into packaging, promotion, and posting on DailyMed for all marketed products
  • Develop SOPs or working instructions to ensure consistent high quality regulatory affairs function and efficient promotional review process
  • Manage the department budget, timelines and resources to achieve stated goals
  • Develop team members to grow to meet Ipsen's evolving business needs in a best-in-class way
  • Complies with all laws, regulations and policies that govern the conduct of Ipsen U.S. staff


Qualifications

Education
  • BS or MS in scientific discipline; advanced scientific degree preferred


Experience
  • 10+ years of experience in the biotech/pharmaceutical industry and a minimum of 5 years in promotional regulatory affairs
  • Management experience with at least 5 years in the pharmaceutical industry managing people
  • Proven biologics or specialty pharmaceuticals experience
  • Experience in Rare Diseases, Neurology, and Oncology a plus
  • Expert current knowledge of post-marketing regulations with technical experience in aspects of drug development and development and maintenance of labeling
  • Solid experience with promotional review and working with FDA (OPDP, APLB) on advertising and promotion issues


Core Competencies (Specific knowledge, skills and abilities that enable an individual to effectively perform the job)
  • Ability to understand and interpret clinical data
  • Excellent oral and written communication and negotiation skills with strong attention to detail and clarity
  • Ability to interact effectively and influence across all levels of the organizations and FDA with a mature appreciation of how the commercial objectives of the company 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.