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.
Vice President of Regulatory Affairs
They are seeking a Vice President of Regulatory Affairs to oversee all regulatory activities including serving as the primary contact with FDA and other regulatory agencies. Build, lead, and manage the Regulatory Affairs function to ensure adherence to regulatory standards and requirements for the c...
Vice President, Regulatory Affairs and Quality Assurance
The Vice President, Regulatory Affairs and Quality Assurance, will lead the regulatory and quality functions for all development-stage programs. Vice President, Regulatory Affairs and Quality Assurance. As a member of the Senior Leadership Team, the VP will work closely with internal teams and exter...
Associate Vice President, Clinical Affairs And Chief Health Officer
University of California Health (UC Health) and the Office of the President (UCOP) seek a collaborative, innovative, clinical leader to serve as the health system's next Associate Vice President, Clinical Affairs and Chief Health Officer (CHO). ASSOCIATE VICE PRESIDENT, CLINICAL AFFAIRS AND CHIEF HE...
Senior Manager, Regulatory Affairs III*
Liaise with colleagues in Regulatory Affairs therapeutics teams, Clients local Affiliates, Regulatory Operations, Regulatory Project Management and third-party local agents to develop filing plans and deliver submissions to agreed priorities and timelines. Job Title: Senior Manager, CMC Regulatory A...
Vice/Senior Vice President of Chemistry
The expected starting salary range for this position based in San Francisco, California is $240,000-$360,000 for Vice President and $270,000-$400,000 for Senior Vice President. We are seeking a strong and motivated Vice or Senior Vice President of Chemistry. Provide leadership for peer-reviewed scie...
Public Relations Senior Vice President, Enterprise
Senior vice presidents (SVP) are senior-level managers who provide leadership in all aspects of Method’s business across client work, business development and agency initiatives. Senior Vice President (San Francisco, California). As an SVP, you will report to a senior member of the Executive Team an...
Public Relations Senior Vice President, Enterprise
Senior vice presidents (SVP) are senior-level managers who provide leadership in all aspects of Method’s business across client work, business development and agency initiatives. Senior Vice President (San Francisco, California). As an SVP, you will report to a senior member of the Executive Team an...
Director/Senior Director, Regulatory Affairs, Therapeutics
Director, Regulatory Affairs, Therapeutics, to lead the regulatory activities of our growing CRISPR-based therapeutic programs as we bring them from concept to market. Collaborate with various regulatory consultants, clinical advisory board members, and board members to maintain regulatory knowledge...
Senior Regulatory Affairs Specialist
Senior Regulatory Affairs Specialist. Must have experience composing submissions for IVD devices. IVD) and medical device licenses for various governmental agencies. Draft, edit, and compile technical documentation and design dossiers to support CE mark/UKCA mark regulatory filings. ...
Senior Vice President of Engineering
Role: Senior Vice President of Engineering. We are seeking a visionary and dynamic Senior Vice President of Engineering to lead our engineering team into the next phase of growth and innovation. The Senior Vice President of Engineering will be a key member of the executive leadership team, responsib...