​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.

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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

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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

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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.