UK Regulatory & Start-Up Specialist – Site Contracts

Precision for Medicine

Greater London

On-site

GBP 50,000 - 70,000

Full time

37 hours ago
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Job summary

Precision for Medicine is seeking a Regulatory and Start Up Specialist in the UK to manage regulatory submissions and site activation activities. The role involves preparing submission dossiers, coordinating with authorities, ethics committees and project teams, and supporting budget/contract negotiations with sites.

Ideal candidates have at least 2 years in regulatory/start-up roles, a life sciences degree (RN or PharmD preferred), and strong English communication skills.

Qualifications

  • Bachelor’s degree in life sciences or related field; RN/PharmD is a plus.
  • 2+ years in regulatory/start-up or site contracts roles in CRO/pharma.
  • Experience with regulatory submissions and timelines under ICH-GCP.

Responsibilities

  • Prepare Clinical Trial Application and submission dossiers for authorities and ethics committees.
  • Coordinate with CA/EC, provide timely responses and updates to leads and PM/teams.
  • Maintain regulatory trackers, plans and start-up materials; ensure on-time site activation.
  • Support budget and contract negotiations with sites; align with Site Contracts Management.

Skills

Regulatory submissions
Contract negotiations
Project coordination
English fluency

Education

Bachelor’s degree in life sciences
RN or Pharmacy degree
Advanced regulatory qualification

Tools

Spreadsheets
Document management systems
Word processing
Electronic mail

Job description

Precision for Medicine is seeking a Regulatory and Start Up Specialist in the UK to manage regulatory submissions and site activation activities. The role involves preparing submission dossiers, coordinating with authorities, ethics committees and project teams, and supporting budget/contract negotiations with sites.

Ideal candidates have at least 2 years in regulatory/start-up roles, a life sciences degree (RN or PharmD preferred), and strong English communication skills.

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