Global global specialty-driven biotech/pharma company, focused on innovation and specialty care. A workplace that recognizes and promotes an entrepreneurial spirit in our employees, and are building a strong legacy of helping patients with difficult-to-treat diseases across many therapeutic diseases areas. Empower teams to deliver effective therapeutic solutions through highly differentiated medicines for patients with unmet needs.

The Vice President, North America Regulatory Affairs will have oversight of all regulatory and quality assurance activities to support company’s marketed products in the US and North America (incl. Canada) and for leading the team involved in such activities.

 

  • 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 company 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 company U.S. staff.
  • 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
  • BS, MS and/or Advanced degree in a scientific discipline
  • Minimum 15 years experience in the biotech/pharmaceutical industry
  • 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 Oncology a plus
  • Expertise 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)
  • Recognized as leader, yet team player, with cross-functional collaborative skill sets.
  • The ability to manage multiple activities or projects

Salary:

up to $380K+ plus Annual Bonus + LTI (Long Term Incentive)

Location:

Greater Boston, MA Area

Relocation:

Yes, full package

Code:

CF- 7790