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Regulatory and Start Up Specialist

1 hour, 51 minutes ago
Italy
Full-time
Mid Level
Operations Specialist
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 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 in line with local requirements and required timelines.
  • Communicate with Competent Authorities and Ethics Committees for study-related matters and handle their responses.
  • Provide regular status updates on submissions to the Start Up Lead, Regulatory Lead, and project team.
  • 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.
  • Work with the assigned site CRA to align communication and secure site activation.
  • Review and manage collection of essential documents needed for site activation and IMP release.
  • Customize patient information sheets and informed consent forms for country and site requirements.
  • Coordinate document translations and maintain audit/inspection readiness and TMF filing.
  • Maintain knowledge of local clinical trial laws and share regulatory updates within the organization.
  • Support budget and contract negotiations, feasibility outreach, and pre-study site visits when required.

Requirements

  • Experience working as a Regulatory/Start Up specialist in a CRO or pharmaceutical/biotech environment.
  • Experience customizing informed consent forms for Italy.
  • Bachelor’s degree in life sciences or a related field, ideally in a scientific or healthcare discipline, or Registered Nurse qualification, or equivalent education/training/experience.
  • Experience with contracts and budgeting 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 arrangement indicated by #LI-Remote.
  • Employment with a global clinical research organization focused on precision medicine and rare diseases/oncology.
  • Equal opportunity employment with non-discrimination protections.
  • Reasonable accommodation support for candidates with disabilities.
  • Access to formal application privacy and applicant privacy notices.

Interested in this position?

Apply directly on the company website

Apply Now

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