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Regulatory and Start Up Specialist

2 hours, 51 minutes ago
Germany
Full-time
Mid Level
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 145

Description

  • Prepare clinical trial application forms and submission dossiers for competent authorities, ethics committees, and other local bodies.
  • Manage initial submissions, amendments, and notifications according to local requirements and required timelines.
  • Interact with competent authorities and ethics committees and handle their responses.
  • Provide regular status updates on submissions to study leadership and project teams.
  • 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 support site activation activities.
  • Review, collect, and manage essential documents required for site activation and IMP release.
  • Customize patient information sheets and informed consent forms for country and site needs.
  • Coordinate document translations and maintain audit- and inspection-ready filing in the TMF.

Requirements

  • Experience working as a Regulatory/Start Up Specialist in a CRO or pharmaceutical/biotech environment.
  • Experience customizing informed consent forms for Germany.
  • Bachelor’s degree in life sciences or a related scientific or healthcare discipline, or Registered Nurse (RN), or equivalent education, training, and experience.
  • Demonstrated experience in contracts and budget negotiation is desirable.
  • Strong communication and organizational skills.
  • Experience using computerized information systems, electronic spreadsheets, word processing, and email.
  • Fluency in English and the local language.
  • Ability to prioritize workload and meet deadlines.

Benefits

  • Remote work option indicated by #LI-Remote.
  • Employment with a global clinical research organization focused on precision medicine, rare diseases, and oncology.
  • Equal Opportunity Employer status.
  • Reasonable accommodation support for candidates with disabilities during the application process.

Interested in this position?

Apply directly on the company website

Apply Now

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