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Regulatory and Start Up Specialist

1 hour, 42 minutes ago
Hungary
Full-time
Junior
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 32

Description

  • Deliver site activation readiness for assigned countries and sites, ensuring timeliness, quality, and risk mitigation.
  • Prepare Clinical Trial Application forms and submission dossiers for Competent Authorities, Ethics Committees, and other local bodies.
  • Manage initial submissions, amendments, and notifications in line with local requirements, company SOPs, and ICH-GCP principles.
  • Interact with Competent Authorities and Ethics Committees, including handling their responses and follow-up questions.
  • Provide regular status updates on regulatory and ethics submissions to study leadership and project teams.
  • Maintain project plans, trackers, and regulatory intelligence tools for assigned responsibilities.
  • Support development of study-specific start-up plans, IMP release requirements, and essential document review criteria.
  • Partner with site CRAs and other functions to coordinate communication, site activation, and collection of essential documents.
  • Customize patient information sheets and informed consent forms for country and site requirements.
  • Facilitate translation and coordination of translated study documents.
  • Act as a subject matter expert on local timelines, site activation critical path data, contract and budget negotiation requirements, and regulatory reviews.
  • Support study 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-specific plans.

Requirements

  • Bachelor’s degree in life sciences or a related scientific or healthcare field, or Registered Nurse qualification, or equivalent 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.
  • Relevant experience in regulatory and site start-up activities, including feasibility, contract negotiations, and CA/EC/IRB submissions, is preferred.
  • Strong communication skills.
  • Strong organizational skills.
  • Experience using computerized information systems, electronic spreadsheets, word processing, and email.
  • Fluency in English.
  • Ability to use 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

  • Remote work designation (#LI-Remote).
  • Equal Opportunity Employer status.
  • Reasonable accommodation support for candidates with disabilities during the application process.
  • Privacy policy protections for applicant data, including a CA privacy notice for California applicants.

Interested in this position?

Apply directly on the company website

Apply Now

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