Senior Vice President Regulatory Affairs

Mantell Associates is currently partnered with a mid-size Biotech focusing on Radiopharmaceuticals and Oncology. They're looking to add a Regulatory lead to take the Regulatory group to the next level and grow it out while being hands on. 

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SVP 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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SVP of Regulatory Affairs - Requirements:

• Advanced degree in a scientific or related field
• Oncology experience
• BLA/NDA experience
• Rare Disease experience is a plus
• Global experience
• 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 +44 (0)20 3854 7700.