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 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
  • Support the development and execution of training for all users of Bicycle Therapeutics' regulatory systems
  • Responsible for the maintenance of Bicycle Therapeutics' regulatory information within the RIM System
  • Collaborate with internal and external regulatory affairs and cross-functional colleagues to ensure the execution of regulatory submissions, including initial submissions, responses to questions, audits, and inspections
  • Collaborate with internal and external regulatory affairs and cross-functional colleagues to ensure robust management and tracking of regulatory information to support key compliance activities, including change management, audits, and inspections
  • Maintain oversight of current and pending relevant regulatory submissions, providing associated metrics, insights, and dashboards as needed
  • Maintenance of all of Bicycle Therapeutics' regulatory operations data and information, including regulatory requirements such as IDMP, SPOR, etc.
  • Monitor the regulatory operations landscape to anticipate and adapt to changes that may impact assigned Bicycle Therapeutics 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, with in-depth knowledge of requirements for Regulatory Operations, including regulatory systems, publishing, and data
  • Experience and involvement in the implementation of regulatory systems, processes, and procedures; and in the development and delivery of associated training
  • Experience and knowledge in the preparation and publishing of regulatory submissions, such as INDs (in eCTD format), CTAs, or regional equivalents
  • Adaptable and strategic thinker with the ability to generate creative solutions to complex problems, identifying different and novel ways to find solutions
  • Highly collaborative, strong relationship-building skills with internal and external partners, with a high level of integrity; Works proactively using solid communication and influencing skills to effectively execute program goals for assigned Bicycle Therapeutics programs or projects
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 + option to buy up to 5 additional days annually
  • Employer contribution to pension (employee does not have to contribute)
  • 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. Therefore, all qualified applicants will be considered for employment, and we do not discriminate on the basis of race, religion, color, gender, sexual orientation, age, disability status, marital status, or veteran status.

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