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Regulatory and Start Up Specialist

20 hours, 28 minutes ago
Romania
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 80

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 local regulatory requirements.
  • 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.
  • 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 review and document collection for activation.
  • Customize patient information sheets and informed consent forms for country/site requirements.
  • Coordinate document translations and maintain audit/inspection readiness and TMF filing.
  • Support budget negotiations, investigator contracts, site feasibility outreach, and pre-study site visits as needed.

Requirements

  • Bachelor’s degree in life sciences or a related scientific/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 or pharmaceutical/biotech environment.
  • Strong communication and organizational skills.
  • Experience using computerized information systems, electronic spreadsheets, word processing, and email.
  • Fluency in English.
  • If applying from Romania, fluency in Romanian, Hungarian, and English is required.
  • Relevant experience in regulatory and site start-up activities, 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 (MD, PhD, PharmD), RAC certification, or a Master’s in Regulatory Science is preferred.

Benefits

  • Remote position (#LI-Remote).
  • 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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