Head of Regulatory Operations

1 week ago

Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time
Job Title: Head of Regulatory Operations

Bicycle Therapeutics is a clinical-stage biopharmaceutical company developing innovative medicines for underserved diseases. We are seeking a highly skilled Head of Regulatory Operations to support the development and implementation of our regulatory systems and operational processes.

Key Responsibilities:
  • Lead the planning, compilation, and publishing of global regulatory submissions in eCTD and non-eCTD formats
  • Support the implementation of our Document Management and Regulatory Information Management System
  • Develop and execute training for all users of our regulatory systems
  • Maintain regulatory information within our RIM System
  • Collaborate with internal and external regulatory affairs and cross-functional colleagues to ensure the execution of regulatory submissions and robust management of regulatory information
Requirements:
  • Demonstrable experience in Regulatory Operations within the pharmaceutical or biotechnology industry
  • Working knowledge of FDA, EMA, and ICH regulatory guidance and regulations
  • Experience in the implementation of regulatory systems, processes, and procedures, and in the development and delivery of associated training
  • Adaptable and strategic thinker with strong relationship-building skills and a high level of integrity
What We Offer:
  • State-of-the-art campus environment with on-campus restaurant and Montessori nursery
  • Flexible working environment
  • Competitive rewards, including annual company bonus and employee recognition schemes
  • 28 days annual leave, plus option to buy up to 5 additional days annually
  • Employer contribution to pension and life assurance cover
  • Private medical insurance, including optical and dental cover
  • Employee assistance program and health cash plan
  • Access to company-subsidized gym membership and cycle-to-work scheme

Bicycle Therapeutics is committed to building a diverse workforce that is representative of the communities we serve. We are an equal opportunities employer and welcome applications from all qualified candidates.

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