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Regulatory and Start Up Specialist

4 days, 8 hours ago
South Korea
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 148

Description

  • Deliver site activation readiness on time and at high quality while identifying and mitigating risks.
  • Prepare Clinical Trial Application forms and submission dossiers for competent authorities, ethics committees, and other local bodies.
  • Manage interactions with competent authorities and ethics committees and respond to questions or requests.
  • Provide regular status updates on submissions and startup progress to study leadership and project teams.
  • Maintain project plans, trackers, and regulatory intelligence tools for assigned responsibilities.
  • Support development of study-specific startup plans, IMP release requirements, and essential document review criteria.
  • Partner with site CRAs and other stakeholders to coordinate communication and secure site activation.
  • Collect, review, and manage essential documents required for site activation and IMP release.
  • Customize patient information sheets and informed consent forms for country or site requirements.
  • Coordinate document translations and maintain awareness of local clinical trial laws, regulations, and timelines.

Requirements

  • Bachelor’s degree in life sciences or a related scientific or healthcare field, or RN, or equivalent education, training, and experience.
  • Pharmacy qualification or pharmacist experience is highly beneficial.
  • 1+ year of experience as a Regulatory or Start-Up Specialist, or in a comparable role, within a CRO, pharmaceutical, or biotech environment.
  • Strong communication and organizational skills.
  • Experience with computerized information systems, electronic spreadsheets, word processing, and email.
  • Fluency in English.
  • Relevant experience in regulatory and site start-up activities, including feasibility, contract negotiations, and CA/EC/IRB submissions, is preferred.
  • Experience using milestone tracking tools or systems is preferred.
  • Ability to prioritize workload and 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.

Benefits

  • Opportunity to work for a growing organization focused on groundbreaking cancer therapies.
  • Input and ideas are valued, nurtured, and used to help drive positive change.
  • Equal Opportunity Employer status.
  • Reasonable accommodation available for candidates with disabilities during the application process.
  • Privacy protections for applicant data, including a separate notice for California applicants.

Interested in this position?

Apply directly on the company website

Apply Now

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