Regulatory and Site Start Up Specialist

About the role

Precision for Medicine is seeking an experienced Regulatory and Site Start‑Up Specialist to support clinical trial submissions and site activation in China. The role will be based in Shanghai or Beijing and will work closely with internal and external stakeholders to ensure timely and compliant trial start‑up.

Key responsibilities

• Prepare and submit Clinical Trial Application Forms and dossiers (initial and amendments) to Competent Authorities, Ethics Committees and other local bodies.
• Interact with authorities, handle queries and track responses to obtain necessary approvals.
• Collect, review and manage essential site documents, including Informed Consent Forms and Patient Information Sheets, ensuring compliance with ICH‑GCP and local regulations.
• Support sites on IRB/EC submissions and coordinate with the Site Contract Management team on budget and contract negotiations.
• Maintain project plans, trackers and regulatory intelligence tools, providing regular updates to the Start‑Up Lead, Regulatory Lead and Project Team.
• Partner with assigned CRA to align communications and facilitate site collaboration.

Required profile

• Proven experience in regulatory affairs and site start‑up for clinical trials, preferably in oncology or rare disease studies.
• Strong knowledge of local Chinese regulations, ICH‑GCP guidelines and ethics committee processes.
• Excellent written and verbal communication in English; Mandarin proficiency is an advantage.
• Ability to work independently, prioritize tasks and mitigate risks to meet timelines.

Required skills

• ICH‑GCP