Regulatory Affairs Specialist

3 days ago


Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time
Company Overview
Bicycle Therapeutics is a pioneering pharmaceutical company pushing the boundaries of innovation in drug development. Our mission is to create life-changing therapies for underserved diseases.

About the Role
We are seeking a skilled Senior Associate, Regulatory Affairs to join our team. As a key member of our regulatory department, you will be responsible for developing and executing global regulatory strategies for assigned programs or projects. Your expertise will ensure seamless compliance with regulatory requirements, enabling us to bring innovative treatments to market quickly and efficiently.

Responsibilities
* Develop, execute, and track global regulatory submissions for assigned BicycleTx 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
* Prepare, draft, and review submissions for assigned BicycleTx programs or projects
* Monitor the regulatory landscape to anticipate and adapt to changes that may impact assigned BicycleTx programs or projects
* Develop and maintain internal cross-functional relationships to support regulatory submissions for assigned BicycleTx programs or projects

Qualifications
* Bachelor's degree in a scientific field or post-graduate degree preferred
* Minimum 2 years experience in the pharmaceutical or biotechnology industry
* Demonstrable knowledge of the role of Regulatory Affairs within the pharmaceutical or biotechnology industry is desirable
* Working knowledge of FDA, EMA, and ICH regulatory guidance and regulations is desirable
* Experience and knowledge in preparation of INDs, CTAs, or regional equivalents is desirable

Salary and Benefits
We offer a competitive salary range of $120,000 - $180,000 per annum, depending on experience, plus benefits including annual company bonus, employee recognition schemes, 28 days annual leave, employer contribution to pension, life assurance cover, private medical insurance, group income protection, employee assistance program, health cash plan, and access to company subsidized gym membership.

Additional Information
Bicycle Therapeutics is committed to building a diverse workforce representative of the communities we serve. We do not discriminate based on race, religion, color, gender, sexual orientation, age, disability status, marital status, or veteran status.

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