UK-based Regulatory & Start-Up Specialist

Precision Medicine Group (New York, United States)

Greater London

On-site

GBP 40,000 - 68,000

Full time

3 days ago

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Job summary

Precision for Medicine is seeking a Regulatory and Start Up Specialist based in the UK to join our growing team. You will prepare regulatory submissions, liaise with authorities, and support site activation activities across studies in precision medicine and oncology.

Strong regulatory knowledge, 2+ years of experience in CRO/pharma environments, and fluent English are required. A background in pharmacy is a plus.

Qualifications

2+ years of regulatory/start-up experience.
Experience with CRO or pharmaceutical/biotech environments.
Fluency in English.

Responsibilities

Prepare Clinical Trial Application forms and submission dossiers for regulatory authorities and ethics committees.
Interact with regulatory authorities and ethics committees; respond to queries.
Update startup leads on submissions and study status.
Maintain project plans, trackers and regulatory intelligence tools.
Support start-up plans, IMP release requirements and essential document reviews.
Collaborate with sites and CRAs to ensure alignment and site activation readiness.
Coordinate translations of documents and maintain TMF readiness.
Monitor timelines and budgets related to site activation and contracts.