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Regulatory and Start Up Specialist

1 hour, 35 minutes ago
Poland
Full-time
Mid Level
Program Manager
Project and Program Management
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 161

Description

  • Prepare clinical trial application forms and submission dossiers for competent authorities, ethics committees, and other local bodies.
  • Manage initial submissions, amendments, and notifications within required timelines to secure trial approvals.
  • Interact with competent authorities and ethics committees and handle their responses.
  • Provide regular status updates to the Start Up Lead, Regulatory Lead, Project Manager, and project team.
  • Maintain project plans, trackers, and regulatory intelligence tools related to assigned work.
  • Support development of study start-up plans, IMP release requirements, and essential document review criteria.
  • Partner with the site CRA to align communication and secure site activation.
  • Review and manage essential documents required for site activation and IMP release.
  • Customize patient information sheets and informed consent forms for country or site-specific requirements.
  • Coordinate document translations and maintain awareness of local clinical trial laws and regulations.
  • Serve as a subject matter expert on site activation critical-path items, including timelines, contracts, budgets, and regulatory reviews.
  • Support budget negotiations, investigator contract execution, feasibility outreach, and pre-study site visits when needed.
  • Maintain audit and inspection readiness and file documents in the TMF according to study plans.

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.
  • Pharmacy qualification or pharmacist work experience is highly beneficial.
  • Demonstrated experience as a Regulatory or Start Up Specialist, or in a comparable role, within a CRO or pharmaceutical/biotech environment.
  • Strong communication and organizational skills.
  • Experience using computerized information systems, electronic spreadsheets, word processing, and email.
  • Fluency in English.
  • Relevant regulatory and site start-up experience, 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, RAC certification, or a Master’s in Regulatory Science is preferred.

Benefits

  • Remote work arrangement indicated by the #LI-Remote tag.
  • Equal Opportunity Employer status.
  • Reasonable accommodation support for applicants with disabilities.
  • Privacy policy and CA privacy notice provided for applicant data protection.

Interested in this position?

Apply directly on the company website

Apply Now

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