Regulatory Affairs Lead

6 days ago

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

Overview

Bicycle Therapeutics is seeking an experienced Regulatory Affairs professional to join our team as an Associate Director, Regulatory Affairs. This role will be responsible for developing and executing regulatory strategy for assigned BicycleTx programs or projects.

Key Responsibilities

  • Regulatory Strategy Development
    • Develop and execute regulatory strategy for assigned BicycleTx programs or projects, including development and maintenance of the Regulatory Plan.
    • Collaborate with cross-functional colleagues to ensure regulatory strategy aligns with business objectives.
  • Regulatory Submissions
    • Oversee the preparation and execution of global regulatory submissions for assigned BicycleTx programs or projects.
    • Collaborate with Regulatory Leads to ensure timely and effective submission of regulatory documents.
  • Regulatory Compliance
    • Maintain regulatory files and tracking databases, including relevant parts of the trial master file.
    • Collaborate with internal colleagues and external regulatory and quality consultants to ensure regulatory compliance.
  • Communication and Collaboration
    • Develop and maintain internal cross-functional relationships to support the development and execution of regulatory strategy.
    • Collaborate with external partners, including health authorities and regulatory agencies.

Qualifications

  • Bachelor's degree in a scientific field or post-graduate degree preferred.
  • Extensive experience in Regulatory Affairs within the pharmaceutical or biotechnology industry.
  • Working knowledge of FDA, EMA, and ICH regulatory guidance and regulations.
  • Experience and knowledge in preparation of INDs, CTAs, NDAs, MAAs, or regional equivalents is required.
  • Experience and knowledge in the supportive interactions with health authorities, including US FDA, EMA, and/or EU Member States, is desirable.
  • An understanding of the drug product lifecycle from discovery to clinical trials to marketing is required.
  • Experience and knowledge of some of the key regulatory pathways for product development, for example, pediatrics plans, orphan drugs, Regulatory Agency advice, expedited development (e.g., Fast Track, Breakthrough Designation, PRIME) is desirable.
  • Therapeutic experience in oncology is desirable.
  • Ability to communicate on topics of basic science is essential; a working knowledge of global drug development, including preclinical and clinical, is required.
  • Ability to proactively identify risks and develop risk mitigation strategies.
  • Adaptable and strategic thinker with the ability to generate creative solutions to complex problems, identifying different and novel ways to find solutions, and adapt to changing priorities and deadlines.
  • 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 BicycleTx programs or projects.
  • Works effectively in a highly complex and fast-paced environment.
  • Strong organizational and time management skills.
  • Position may require some domestic and international travel.

Additional Information

  • Bicycle Therapeutics offers a competitive reward package, including annual company bonus, employee recognition schemes, and a comprehensive benefits package.
  • State-of-the-art campus environment with on-campus restaurant and Montessori nursery.
  • Flexible working environment.
  • 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.

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