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Regulatory and Start Up Specialist - Fluent in Hungarian

2 hours, 23 minutes ago
Poland
Mid Level
Compliance Manager
Operations
Apply Now
Precision For Medicine

Precision For Medicine

Precision for Medicine is a specialized scientific services company that helps pharmaceutical and life sciences clients innovate, develop, and commercialize next-generation medical products. With a diverse team of experts, they offer comprehensive serv...

Pharmaceuticals
1K-5K
Founded 2012
$225M raised
View All Jobs 92

Description

  • Coordinate timely, quality site activation readiness and mitigate activation risks.
  • Prepare clinical trial applications and submission dossiers for Competent Authorities, Ethics Committees, and other local bodies.
  • Interact with regulatory authorities and ethics committees and manage responses.
  • Maintain project plans, trackers, regulatory intelligence tools, and site activation critical paths.
  • Develop or support study-specific start-up plans, IMP release requirements, and essential document review criteria.
  • Collect and manage essential documents required for site activation and IMP release.
  • Customize patient information sheets and informed consent forms and coordinate document translations.
  • Collaborate with CRAs, feasibility, clinical operations, project management, regulatory, and site contracts teams.
  • Support site outreach, feasibility activities, budget negotiations, investigator contracts, and pre-study site visits as needed.
  • Maintain regulatory knowledge, audit and inspection readiness, and accurate filing in the relevant TMF.

Requirements

  • Bachelor’s degree in life sciences or a related scientific or healthcare field, RN qualification, or equivalent education, training, and experience.
  • Demonstrated experience as a Regulatory or Start Up Specialist, or in a comparable CRO, pharmaceutical, or biotechnology role.
  • Fluency in Hungarian and English.
  • Strong communication, organizational, prioritization, and deadline-management skills.
  • Experience with computerized information systems, spreadsheets, word processing, and email.
  • Relevant experience with feasibility, contract negotiations, and Competent Authority, Ethics Committee, or IRB submissions preferred.
  • Experience using milestone tracking tools or systems preferred.
  • Pharmacy qualification or Pharmacist experience preferred.
  • Advanced degree in medical or life sciences, RAC certification, or a Master’s in Regulatory Science preferred.
  • Must be legally authorized to work in the country of employment without employer sponsorship.

Interested in this position?

Apply directly on the company website

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