Regulatory Affairs Manager

London
1 month ago
Applications closed

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Regulatory Affairs Manager

Regulatory Affairs Manager

Regulatory Affairs Manager

Regulatory Affairs Manager

Regulatory Affairs Manager

Regulatory Affairs Manager

Regulatory Affairs Manager

8+ Month FTC | Fully Remote (UK or Sweden)

Are you an experienced Regulatory Affairs professional looking for your next impactful contract role? We are seeking a Regulatory Affairs Manager to support a growing portfolio of clinical development activities. This is an excellent opportunity to join a forward‑thinking team, work fully remotely, and play a key role in shaping regulatory strategies across Europe.

About the Role

As the Regulatory Affairs Manager, you will lead and support the planning, preparation, and submission of Clinical Trial Applications (CTAs) across Europe. You will collaborate closely with internal teams, CRO partners, and regulatory bodies to ensure timely and compliant submissions, while bringing your expertise to a portfolio of innovative clinical programs.

This is an 8‑month+ fixed‑term contract, with strong potential for extension.

Education Requirements

  • Bachelor’s degree required, preferably in a life science discipline or equivalent.

    What We’re Looking For

  • 4+ years’ experience working in a regulatory role within clinical trials in the pharmaceutical or CRO industry.

  • 5+ years’ experience strategically planning, compiling, and submitting European Clinical Trial Applications.

  • Strong, hands‑on experience with CTIS and IRAS, including full CTA preparation and submission.

  • Previous experience working within a CRO environment is highly desirable.

  • Exposure to national regulatory submissions, such as GMO and radiation safety applications, is preferred.

  • Experience preparing County-specific ICFs is also beneficial.

    Location & Working Model

  • Fully remote role

  • Candidates must be based in either the UK or Sweden

  • Occasional travel may be required (minimal)

    Why Join?

  • Opportunity to support meaningful clinical development projects

  • Work with a collaborative, dynamic team

  • Flexible, remote working environment

  • Competitive FTC package and immediate start availability

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