Associate Director, Regulatory Operations
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 The Associate Director, Regulatory Operations role will be responsible for daily operational activities within Regulatory Affairs to ensure delivery of timely, accurate, and high-quality submissions to regulatory health authorities. Reporting to the Senior Director, Regulatory Operations, this role is also responsible for the implementation and management of regulatory systems and processes to ensure compliance.
Requirements
- Bachelor’s degree in a scientific or related field.
- Minimum 8 years' experience in a biotech or pharmaceutical company with at least 5 years of experience in regulatory operations.
- Hands-on experience formatting, publishing, compiling, and dispatching regulatory submissions in eCTD format.
- Direct experience supporting or administering a validated, document management system (Veeva Vault RIM strongly preferred).
- Highly proficient in MS Word document formatting with and without the use of third-party authoring templates.
- Knowledge of global regulatory submission regulations and submission requirements.
- Strong project management skills, detail oriented, and team-oriented leadership skills are essential.
- Ability to work independently, within a multi-disciplinary team, as well as with external partners and vendors.
Nice To Haves
- Direct experience with compiling major submission applications (e.g., Original NDA/BLA/MAA) is preferred.
- Experience managing external publishing vendors is preferred.
Responsibilities
- Responsible for forward planning of publishing resources; provide operational oversight of external publishing vendors for the coordination, delivery, and dispatching of regulatory submissions.
- Maintain electronic regulatory systems necessary to carry out functional activities; work with solution providers to identify, validate, and implement system enhancements.
- Train and support cross-functional contributors on the use of regulatory systems to support submission planning and execution.
- Maintain accurate, accessible records of submission filings, health authority correspondences, and regulatory milestones.
- Perform document formatting and publishing to generate submission-ready documents in accordance with regional specifications and requirements.
- Work closely with the other members of the Regulatory Affairs team to provide submission and publishing strategy support as needed.
- Lead the development and maintenance of SOPs and work instructions related to electronic submissions, records management, and regulatory systems.
- Drive continued evolution of reporting and analytics capabilities using systems and tools to provide a robust view of regulatory activities.
- Evaluate and communicate emerging technology changes and regulatory submission requirements to inform decision making and long-range planning.
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
Number of Employees
51-100 employees
