Head of Regulatory Operations

1 week ago

Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time
Job Description

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

Key Responsibilities
  • Lead and manage planning, compilation, and publishing of global regulatory submissions in eCTD and non-eCTD formats
  • Publish global regulatory submissions in eCTD and non-eCTD formats
  • Support the implementation of Bicycle Therapeutics' Document Management and Regulatory Information Management System
  • Develop and execute training for all users of Bicycle Therapeutics' regulatory systems
  • Maintain regulatory information within the RIM System
  • Collaborate with internal and external regulatory affairs and cross-functional colleagues to ensure the execution of regulatory submissions
  • Monitor the regulatory operations landscape to anticipate and adapt to changes that may impact assigned programs or projects
Requirements
  • Demonstratable experience in Regulatory Operations within the pharmaceutical or biotechnology industry
  • Working knowledge of FDA, EMA, and ICH regulatory guidance and regulations
  • Experience and involvement in the implementation of regulatory systems, processes, and procedures
  • Experience and knowledge in the preparation and publishing of regulatory submissions
  • Adaptable and strategic thinker with strong relationship building skills
What We Offer
  • State-of-the-art campus environment with on-campus restaurant and Montessori nursery
  • Flexible working environment
  • Competitive reward including annual company bonus
  • Employee recognition schemes
  • 28 days annual leave in addition to bank holidays
  • Employer contribution to pension
  • Life assurance cover 4x basic salary
  • Private Medical Insurance, including optical and dental cover
  • Employee assistance program
  • Health Cash Plan
  • Access to company subsidized gym membership
  • Eligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc
  • 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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