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Regulatory and Site Start Up Specialist

3 hours, 11 minutes ago
China
Full-time
Junior
Compliance Manager
Operations
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 63

Description

  • Prepare clinical trial application forms and submission dossiers for competent authorities, IRB/ethics committees, and other local bodies.
  • Manage initial submissions, amendments, and notifications within required timelines and in accordance with local and international regulations, company SOPs, and ICH-GCP.
  • Interact with competent authorities and ethics committees, and handle their questions and responses.
  • Provide regular updates on submission status, project plans, trackers, and regulatory intelligence tools to regulatory leadership and project teams.
  • Support study-specific start-up plans, IMP release requirements, and essential document review criteria.
  • Prepare, review, and collect essential documents needed for site activation and IMP release.
  • Customize patient information sheets and informed consent forms for country and site requirements.
  • Coordinate translations for submission-related documents.
  • Collaborate with site CRAs, feasibility, clinical operations, project management, regulatory, and site contracts teams to support start-up deliverables.
  • Support budget and investigator contract negotiations when required.
  • Maintain audit and inspection readiness and file documents according to the TMF plan.
  • Support feasibility outreach, pre-study site visits, process improvements, training, and mentoring as needed.

Requirements

  • Bachelor’s degree in life sciences or a related scientific or healthcare field, or Registered Nurse (RN), or an equivalent combination of education, training, and experience.
  • 1+ year of experience in a regulatory or site start-up specialist role, or a comparable role, in a CRO, pharmaceutical, or biotech setting.
  • Strong communication and organizational skills.
  • Experience using 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.
  • Relevant country-specific experience in feasibility, contract negotiations, and CA/EC/IRB submissions is preferred.
  • Experience using milestone tracking tools or systems is preferred.
  • Ability to prioritize workload to meet deadlines is preferred.
  • Advanced degree in medical or life sciences (MD, PhD, PharmD), RAC certification, or a Master’s in Regulatory Science is preferred.

Interested in this position?

Apply directly on the company website

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