VP of Regulatory Affairs - Cell and Gene

Posted 08 December 2023
LocationUnited States of America
Job type Full Time
Discipline Cell & Gene Therapy
Contact NameNikhil Akkoo

Job description

​Mantell Associates is currently partnered with an exciting Cell & Gene organisation, who are looking to bring in a VP of Regulatory Affairs to take the company to new heights as they continue to grow.

VP of Regulatory Affairs - Responsibilities:

  • Provide leadership and oversight to the Regulatory Affairs team, including hiring, managing, motivating, coaching and mentoring

  • Define and oversee implementation and maintenance of the Regulatory and Quality Management System

  • Spearhead regulatory submissions for clinical trials and product approvals, including interactions with regulatory agencies, consultants, and partners

  • Participate as a core member of the Operations Leadership Team, which is responsible for operational oversight of all operations

  • Participate as a core member of the Executive Team, providing strategic guidance related to regulations within the overall organisation

  • Provide strategic advice to cross-functional teams on regulatory requirements and timelines for product development and commercialisation

  • Ensure that all regulatory compliance documents are prepared in accordance with regulatory guidelines, internal standards and SOPs

VP of Regulatory Affairs - Requirements:

  • Advanced degree in a scientific or related field

  • Proven industry experience within pharma, biopharma and/or biotech companies

  • Direct experience interacting with FDA and other regulatory authorities

  • Leadership experience with direct reports and indirect reports

  • Someone that can be a voice and manage up and down

  • Excellent communication and interpersonal skills, with the ability to interact effectively with internal and external stakeholders

Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at +1 (786) 485 1298.