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Regulatory and Start Up Specialist

1 hour, 51 minutes ago
Hungary
Full-time
Junior
Compliance 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 152

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 and in line with local requirements, company SOPs, and ICH-GCP principles.
  • Interact with Competent Authorities and Ethics Committees and handle their responses.
  • Provide regular updates on CA and EC submissions to study leadership, project management, 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 secure site review and essential document collection for site activation and IMP release.
  • Customize country- and site-specific Patient Information Sheets and Informed Consent Forms.
  • Coordinate translations for required documents.
  • Track site activation critical path items such as authority timelines, ethics timelines, contracts, and budget negotiation requirements.
  • Support negotiation of study budgets and execution of investigator contracts when needed.
  • Support feasibility activities, including site outreach to assess investigator interest in potential studies.
  • Maintain audit and inspection readiness and file documents in the TMF according to study plans.
  • Support pre-study site visits when required.

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.
  • Demonstrated experience as a Regulatory or Start Up specialist, or in a comparable role, in a CRO, pharmaceutical, or biotech environment.
  • Relevant regulatory and site start-up experience, including feasibility, contract negotiations, and CA/EC/IRB submissions, preferred.
  • Strong communication and organizational skills.
  • Experience using computerized information systems, electronic spreadsheets, word processing, and email.
  • Fluency in English.
  • Experience using milestone tracking tools or systems preferred.
  • Ability to prioritize workload and meet deadlines preferred.
  • Advanced degree in medical or life sciences (MD, PhD, PharmD), RAC certification, or a Master’s in Regulatory Science preferred.

Benefits

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

Interested in this position?

Apply directly on the company website

Apply Now

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