VP, Regulatory Affairs

Location
Cambridge, MA, United States
Posted
Aug 07, 2018
Ref
477282
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
Title:
VP, Regulatory Affairs

Company:
Ipsen Biopharmaceuticals Inc.

Job Description:

Position Summary

The Vice President, Regulatory Affairs will report into the Chief Executive Officer of Ipsen North America and sit on the North America Leadership Team. The incumbent will lead to ensure efficient and compliant functioning of all promotional review for Ipsen's products, and to insure all regulatory reporting requirements such as post-marketed safety reports, annual and periodic reports for marketed products, are completed and filed on time. S/he will be responsible for managing and evolving the Promotional Review Committee and Medical Review committee processes to ensure that the business needs are met efficiently and effectively. In addition, this individual will be responsible for regulatory support of Phase IV studies being conducted the Ipsen US affiliate. The position requires interaction with Global Regulatory Affairs, Global Product Safety, US Medical Affairs, US Legal Affairs and Compliance and commercial functions for the purpose of providing regulatory insight during promotional plan development and implementation to ensure conformity with FDA expectations and requirements. The position requires interaction with additional external stakeholders, which may include other health authorities globally, Key Opinion Leaders, Advisory Committees, investors, potential partners, CROs, Company's Board of Directors and other contracted service providers.

Responsibilities
Responsibilities will include, but are not limited to, the following:
  • Lead and direct the affiliate regulatory affairs and quality assurance teams
  • Provide expert input into promotional regulatory strategies to ensure compliance with FDA guidance's on advertising and promotion while meeting business needs
  • Participate the development of US affiliate clinical plans to ensure protocol design, endpoint are consistent with US quality and clinical trials requirements
  • Build strong relationship with FDA's Office of Prescription Drug Promotion (OPDP) and act either individually or through a delegate as the primary FDA OPDP regulatory contact on matters related to advertising and promotion
  • Create or develop SOPs or working instructions to ensure consistent high quality regulatory affairs function
  • Develop team members to grow to meet Ipsen's evolving business needs in a best-in-class way
  • Provides regulatory support to the business development activities to review potential licensing candidates
  • Complies with all laws, regulations and policies that govern the conduct of Ipsen U.S. staff

Education
  • Bachelor's degree in scientific or life sciences discipline or related required, Advanced degree in scientific or life sciences discipline or related (e.g., PharmD, PhD, MD) strongly preferred

Experience
  • A minimum of 15 years of experience in the biotech/pharmaceutical industry and a minimum of 10 years in regulatory affairs
  • At least 8 years of experience managing a group in the pharmaceutical industry
  • Experience with peptides or proteins and toxins plus
  • Experience in Endocrinology, Neurology, and Oncology a plus
  • Expert current knowledge of regulations and drug development guidelines with some technical experience in aspects of drug development.
  • Solid experience with promotional review and working with FDA's Office of Prescription Drug Promotion (OPDP)

Core Competencies
  • Candidate must be able to demonstrate strong relationship management, project management, problem-solving, negotiating, interpersonal and communication skills (both written and oral), and strong attention to detail and clarity
  • Ability to interact effectively across all levels of the organizations; integrates functional expertise with regulatory knowledge to solve problems, meet priorities and deadlines in alignment with US/Canada goals and objectives
  • Demonstrated experience leading face-to-face and other formal interactions with senior regulatory agency representatives
  • Poised, knowledgeable verbal scientific presenter with experience in presentations within Pharma industry and externally (medical congresses)
  • The ability to manage multiple activities or projects


Ipsen Biopharmaceuticals, Inc. is an equal opportunity employer. We recruit, employ, train, compensate, and promote without regard to race, religion, creed, national origin, age, gender, sexual orientation, sexual identity, marital status, military or veteran status, disability, genetic information, or any other category protected by applicable federal, state or local law.

Ipsen Biopharmaceuticals, Inc. conducts background screening, reference checks, and drug testing as part of its pre-employment screening process. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned.

All Employees are expected to adhere to all company policies and act as a role model for company values.

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.