Vice President, Regulatory Affairs
The mission of Centessa Pharmaceuticals plc (Nasdaq: CNTA) is to deliver consequential new medicines to patients. The Centessa family includes ten wholly owned, highly specialized companies, with drug discovery and development programs in diverse therapeutic areas. The company’s organizational structure and approach combine the agility and sense of urgency typical of start-up companies with the scale and diversification typical of larger R&D organizations.
As we continue to grow, we are seeking a seasoned Vice President of Regulatory Affairs leader to drive the regulatory strategy for programs while overseeing and supporting the growing global regulatory clinical development team and all aspects of the clinical development programs in advanced products. This is a fast-paced, highly dynamic work environment within a very employee-centric biotech setting. This role is highly visible and will have internal senior management influence as well as act as the primary liaison with agency interactions, external vendors, corporate partners in the development, operations, and registration initiatives.
- Lead the regulatory function and enable rapid and successful product development, approvals, and life-cycle management.
- Establish the long-term strategy for the regulatory team, activities, and planning in accordance with an established road map, with an expectation to scale-up efficiently and rapidly.
- Provide strong cross-functional leadership for global filings
- Build the regulatory function, build, and maintain strong leadership capabilities at all levels within the regulatory team and support the professional development of regulatory team members.
- Ensure the successful on time delivery of high-quality submissions to global regulatory health authorities in alignment with both Centessa and health authority standards.
- Oversee the development and implementation of innovative systems, tools and streamlined processes to create and maintain high-quality regulatory submissions and manage a state-of-the-art regulatory intelligence and knowledge management approach.
- Responsible for continuous improvement of systems and processes, including internal training, for the regulatory department and cross functional team
- Ensure inspection readiness efforts for regulatory activities and files
- Manage regulatory budgets and vendors
- Maintain current expertise in regulatory trends and operations
- Participate as needed in technical discussions and collaborate with corresponding groups at Health Authorities to advance Regulatory Science
- Bachelor of Science degree in Life Sciences or Biology or equivalent required with at least 15-20 years of relevant regulatory industry experience in a biotech/pharmaceutical setting with 10 years of global regulatory leadership experience managing regulatory teams and led project development teams to successful marketing authorizations.
- Experience driving global regulatory strategy for multiple programs
- Strong understanding of advanced therapy product development within including multidisciplinary experience.
- Extensive and comprehensive knowledge of the drug development process.
- Experience interfacing and responding to relevant global regulatory authorities
- Proven experience in global regulatory submissions (EU, UK, US, and RoW), in particular INDs/CTAs, briefing documents, PIPs/PSPs, orphan designations, and MAA/BLAs.
- Ability to think strategically and critically and evaluate risks to regulatory activities; ability to work effectively within a complex, business-critical, and high-profile development program.
POSITION: Full-Time, Exempt, Flexibility for Remote Work
EEOC Statement: Centessa Pharmaceuticals believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Centessa Pharmaceuticals will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
NO THIRD PARTY RESUMES WILL BE ACCEPTED AT THIS TIME.