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Centessa Pharmaceuticals · 1 day ago

Associate Director, Regulatory Operations

United States

Full-time

Remote

Lead/Staff, Director/Executive

$170K/yr - $225K/yr

8+ years exp

Centessa Pharmaceuticals is a new kind of pharmaceutical company with a focus on data-driven decision making and a unique R&D model. The Associate Director, Regulatory Operations will oversee daily operational activities within Regulatory Affairs to ensure timely and high-quality submissions to regulatory health authorities, while managing regulatory systems and processes for compliance.

BiotechnologyPharmaceutical

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

Qualification

Regulatory operations experienceECTD format submissionsDocument management systemMS Word proficiencyGlobal regulatory knowledgeVendor management experienceProject management skillsDetail orientedTeam-oriented leadershipIndependent work ability