Associate Director, Regulatory Affairs
About The Position
Centessa Pharmaceuticals plc (Nasdaq: CNTA) new kind of pharmaceutical company with a deconstructed R&D environment that prioritizes data driven decision making led by subject matter experts. Centessa is advancing a portfolio of high conviction programs with strong biological validation. Our asset-centric model offers a unique R&D logic that has been applied by single asset companies to improve productivity. This operating model has minimal centralized infrastructure, reduced hierarchy, and exclusive focus on data driven capital allocation. Our teams are uniquely incentivized to expeditiously interrogate key scientific hypotheses. We believe the asset-centric model can lead to improved success rates for programs with greater speed and modest costs. Description of Role Our Associate Director, Regulatory Affairs Reporting will be responsible for performing and managing key regulatory activities that are compliant with US, ex-US, and company standards. Reporting to the Executive Director, Regulatory Affairs, you will act as the regulatory lead on project teams, providing regulatory guidance and oversight. You will also contribute to regulatory affairs initiatives aimed at improving internal standards and systems.
Requirements
- Minimum of 6+ years' experience in a biotech and/or pharmaceutical environment, including 4+ years in Regulatory Affairs
- Minimum requirement of a bachelor's degree in a scientific discipline or equivalent
- Team player that can handle multiple tasks simultaneously in a fast-growing company
- Possess outstanding verbal and written communication skills
- Requires a highly motivated, resourceful, creative individual who can set goals, shift priorities, work independently and collaborate effectively with project teams
- Excellent organizational skills and attention to detail
Nice To Haves
- Experience in neuroscience therapeutic areas preferred
Responsibilities
- Act as the primary regulatory representative on and provide strategic regulatory guidance to project teams and sub-teams. Proactively define and assess regulatory risks associated with product development for assigned products
- Lead the planning and preparation of global regulatory submissions (eg, INDs, CTAs, meeting requests, investigation plans, responses to health authorities)
- Serve as the liaison between the company and regulatory agencies for assigned projects
- Prepare regulatory development plans for assigned projects
- Maintain active INDs/CTAs (amendments and annual reports)
- Develop and maintain regulatory knowledge of US, EU and ROW regulations
- Perform literature searches, prepare special reports and assemble documentation to support project teams
- Interface with CMC, nonclinical research and clinical research personnel and help keep them apprised of new regulations, standards, policies, and guidance issued by regulatory authorities that may impact the company
- Assist in the development and maintenance of departmental processes, policies, SOPs and associated documents
- Participate in initiatives aimed at improving internal departmental standards and systems
Benefits
- In addition to base pay, this role is eligible for a discretionary annual bonus and participation in our equity program, allowing you to share in Centessa's long-term success.
- Centessa also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Industry
Professional, Scientific, and Technical Services
Number of Employees
51-100 employees
