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.
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
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
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.
