Vice President of Regulatory Affairs

Xemplar Workforce Solutions - Salt Lake City, UT

This is a senior Quality Leadership role within an emerging company that is revolutionizing the treatment of serious and debilitating diseases through the commercialization of novel drug and cellular therapeutics leveraged by proprietary gene-based companion diagnostics.

The primary purpose of the Vice President of Regulatory Affairs position is to ensure worldwide regulatory strategies are clearly delineated, supported and implemented in the development, commercialization and life cycle management of the business’s Human Cell and Tissue Products (HCT/Ps).

The successful candidate will lead the development of global regulatory strategies and timelines for HCT/P product development projects, working through cross-functional teams to ensure that various pathways are examined early in the process. An assessment of the business risks associated with the preferred regulatory strategies, along with the mitigation plans must be presented to the project team and management in order to keep commercialization progress on track. You will also contribute to the preparation and submission of domestic 510(k), Instructional Review Board (IRB), Investigational New Drug Application (IND) and international regulatory filings for the business group in accordance with policies and procedures established by the company and regulatory agencies.

Qualification for the Vice President of Regulatory Affairs position include:

Education

  • A minimum of a Bachelor’s degree is required.

Experience

  • Demonstrated track record in leading all areas of regulatory affairs for a company that manufacturers OrthoBiologic or other HCT/P products.
  • Extensive knowledge and experience in designing regulatory & clinical strategies and submissions of product registrations HCT/P or Drug companies.
  • Minimum of 10 years of experience in a position that requires broad experience surrounding regulatory affairs.
  • A proven track record of building an effective regulatory affairs team.
  • Excellent analytical, interpersonal, and communication skills.
  • Ability to work well with senior management.

Preferred Experience

  • Extensive knowledge and experience in designing regulatory & clinical strategies along with submissions of product registrations for HCT/P or 351 Products.
  • Minimum of five years of experience in a role of Director of Regulatory Affairs or higher.
  • Bachelor’s or advanced degree in the physical sciences, biomaterials or related area.
  • Significant experience gaining regulatory approvals for HCT/Ps outside of the United States.

Benefits of the Vice President of Regulatory Affairs position include:

  • Salary will commensurate with experience for this senior leadership role.
  • Excellent benefits including: Medical, Dental, Group Term Life, Disability, Pension Plan Plus (401k and Pension Benefits), Flex-Spending, and other miscellaneous value-added benefits.

XEM17



Posted On: Monday, October 29, 2018

Tagged: Professional


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