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Regulatory and Site Start Up Specialist

3 weeks ago
China
Full-time
Junior
Compliance Manager
Project and Program Management
Apply Now
Precision Medicine Group

Precision Medicine Group

Precision Medicine Group specializes in precision medicine, utilizing targeted expertise and data insights to accelerate drug development and enhance the commercialization of next-generation medical products for the pharmaceutical and life sciences ind...

Pharmaceuticals
251-1K
Founded 2012
View All Jobs 83

Description

  • Prepare clinical trial application forms and submission dossiers for Competent Authorities, Ethics Committees, IRBs, and other local bodies.
  • Manage initial and amendment submissions, responses, and follow-up communication with regulatory authorities and ethics committees.
  • Support site activation readiness by collecting, reviewing, and maintaining essential documents and site-level critical path data.
  • Customize patient information sheets and informed consent forms for country- and site-specific requirements.
  • Coordinate document translations and submission materials needed for regulatory and site start-up activities.
  • Maintain project plans, trackers, and regulatory intelligence tools, and provide status updates to study leadership and project teams.
  • Partner with CRAs, feasibility, clinical operations, project management, and site contracts teams to support start-up execution.
  • Support budget and investigator contract negotiations when required.
  • Act as a subject matter expert on local clinical trial regulations, timelines, and site start-up processes.
  • Maintain audit and inspection readiness and ensure filing compliance with TMF and study plans.

Requirements

  • Bachelor’s degree in life sciences or a related scientific or healthcare field, or RN, or equivalent education/training/experience.
  • 1+ year of experience as a Regulatory or Site Start-Up specialist, or in a comparable CRO, pharmaceutical, or biotech role.
  • Strong communication and organizational skills.
  • Experience with computerized information systems, electronic spreadsheets, word processing, and email.
  • Fluency in English and, for non-English speaking countries, the local language of the country where the position is based.
  • Preferred: relevant country-specific experience with feasibility, contract negotiations, and CA/EC/IRB submissions.
  • Preferred: experience using milestone tracking tools or systems.
  • Preferred: ability to prioritize workload and meet deadlines.
  • Preferred: advanced degree in medical or life sciences (MD, PhD, PharmD), RAC certification, or a Master’s in Regulatory Science.

Benefits

  • Equal opportunity employer.
  • Reasonable accommodation available for applicants with disabilities.
  • Privacy policy and CA privacy notice provided for applicant data protection.

Interested in this position?

Apply directly on the company website

Apply Now

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