Associate Director, Regulatory Affairs at Centessa Pharmaceuticals
Interview Preparation Plan
As an Associate Director of Regulatory Affairs at Centessa Pharmaceuticals, you will be instrumental in managing and executing key regulatory activities in compliance with US, ex-US, and company standards. Reporting to the Executive Director, Regulatory Affairs, this role acts as the primary regulatory lead on project teams, providing strategic guidance and oversight. You will also contribute to the continuous improvement of internal regulatory affairs standards and systems, ensuring the company's drug development programs meet all necessary regulatory requirements. This position requires a proactive and detail-oriented individual who can navigate complex regulatory landscapes and foster strong collaborations. You will be responsible for risk assessment, leading global regulatory submissions, and serving as the main liaison between Centessa and regulatory agencies. The role involves staying abreast of evolving regulations and contributing to the development of departmental processes and policies in a fast-growing environment.
Key Responsibilities
- Act as the primary regulatory representative and provide strategic regulatory guidance to project teams.
- Lead the planning and preparation of global regulatory submissions (e.g., INDs, CTAs, meeting requests, responses to health authorities).
- Serve as the liaison between Centessa Pharmaceuticals and regulatory agencies for assigned projects.
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