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Centessa Pharmaceuticals · 4 hours ago

Associate Director, Regulatory Affairs

United States

Full-time

Remote

Senior Level, Lead/Staff, Director/Executive

$170K/yr - $225K/yr

6+ years exp

Centessa Pharmaceuticals is a new kind of pharmaceutical company with a focus on data-driven decision making in a unique R&D environment. The Associate Director, Regulatory Affairs will manage key regulatory activities, provide guidance on project teams, and contribute to initiatives aimed at improving regulatory standards and systems.

BiotechnologyPharmaceutical

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

Qualification

Regulatory AffairsGlobal regulatory submissionsBiotech experienceNeuroscience therapeutic areasVerbal communicationWritten communicationOrganizational skillsAttention to detail

Required

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