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Regulatory and Start Up Specialist

2 days ago
Taiwan
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 132

Description

  • Prepare clinical trial application forms and submission dossiers for Competent Authorities, Ethics Committees, and other local bodies.
  • Manage CA/EC interactions and responses to support study approvals.
  • Provide regular updates on submission status to Start Up Leadership, Regulatory Leadership, and the project team.
  • Maintain project plans, trackers, and regulatory intelligence tools for assigned responsibilities.
  • Support development of study start-up plans, IMP release requirements, and essential document review criteria.
  • Partner with site CRAs to align communication and secure site activation.
  • Review and manage essential documents required for site activation and IMP release.
  • Customize country- and site-specific Patient Information Sheets and Informed Consent Forms.
  • Coordinate translations of study documents and related materials.
  • Track country start-up milestones, including local timelines, site contracts, budget negotiations, and other required reviews.
  • Support study budget negotiations and investigator contract execution when required.
  • Assist feasibility teams with site outreach and investigator interest assessments.
  • Maintain awareness of local clinical trial laws and regulations and share that knowledge internally.
  • Maintain audit and inspection readiness and file documents in the TMF according to study plans.
  • Support pre-study site visits when needed.

Requirements

  • Bachelor’s degree in life sciences or a related field, ideally in a scientific or healthcare discipline, or RN/equivalent education and experience.
  • Pharmacy qualification or pharmacist work experience is highly beneficial.
  • At least 1 year of experience as a Regulatory or Start Up Specialist, or in a comparable role, in a CRO, pharmaceutical, or biotech environment.
  • Strong communication and organizational skills.
  • Experience using computerized information systems, electronic spreadsheets, word processing, and email.
  • Fluency in English.
  • Experience in regulatory and site start-up activities, including 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, preferred.

Interested in this position?

Apply directly on the company website

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