Regulatory Affairs Specialist

1 month ago


Cambridge, Cambridgeshire, United Kingdom Vertex Ventures HC Full time

We are seeking an experienced Regulatory Affairs Specialist to join our team at Vertex Ventures HC. In this role, you will play a critical part in ensuring the regulatory compliance of our cancer therapies.

As a key member of our Regulatory Affairs team, you will be responsible for developing and executing global regulatory strategies for assigned programs or projects. You will work closely with cross-functional colleagues to ensure timely execution of regulatory submissions, responses to questions, audits, and inspections.

The ideal candidate will have a bachelor's degree in a scientific field or post-graduate degree, with a minimum of 2 years experience in the pharmaceutical or biotechnology industry. They will possess demonstrable knowledge of the role of Regulatory Affairs within the pharmaceutical or biotechnology industry, as well as working knowledge of FDA, EMA, and ICH regulatory guidance and regulations.

In addition to these qualifications, the successful candidate will have therapeutic experience in oncology, ability to communicate on topics of basic science, and strong organizational and time management skills.

Bicycle Therapeutics is committed to building a diverse workforce that is representative of the communities we serve. We offer a competitive rewards package, including annual company bonus, employee recognition schemes, and comprehensive benefits such as life assurance cover, private medical insurance, and access to company-subsidized gym membership.

Key Responsibilities:
  • Develop and execute global regulatory strategies for assigned programs or projects
  • Maintain regulatory files and tracking databases, including relevant parts of the trial master file
  • Collaborate with internal colleagues and external organizations to support timely execution of regulatory submissions, responses to questions, audits, and inspections
Requirements:
  • Bachelor's degree in a scientific field or post-graduate degree preferred
  • Minimum of 2 years experience in the pharmaceutical or biotechnology industry
  • Demonstrable knowledge of the role of Regulatory Affairs within the pharmaceutical or biotechnology industry desirable

$120,000 - $150,000 per annum, depending on experience. State-of-the-art campus environment with on-campus restaurant and Montessori nursery. Flexible working environment. Annual company bonus.



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