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Regulatory and Start Up Specialist

2 hours, 7 minutes ago
Poland
Full-time
Mid Level
Compliance Manager
Project and Program Management
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 52

Description

  • Deliver site activation readiness for assigned countries and sites, managing timeliness, quality, and risk mitigation.
  • Prepare Clinical Trial Application forms and submission dossiers for competent authorities, ethics committees, and other local bodies.
  • Manage submissions, amendments, and notifications in line with local requirements, company SOPs, and ICH-GCP principles.
  • Interact with competent authorities and ethics committees and handle their questions and responses.
  • Provide regular status updates on CA/EC submissions to study leadership, project managers, and project teams.
  • 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 site CRAs and other key functions to align communication and support site activation.
  • Review, collect, and file essential documents required for site activation and IMP release in the TMF.
  • Customize patient information sheets and informed consent forms for country/site requirements.
  • Coordinate document translations and support translation-related activities.
  • Act as a subject matter expert for site activation timelines, contracts, budget negotiation requirements, and other critical path data points.
  • Support study budget negotiations and investigator contract execution when required.
  • Support feasibility efforts, including site outreach and pre-study site visits when needed.
  • Maintain up-to-date knowledge of local clinical trial laws and regulations and share that knowledge internally.

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 flexibility indicated by the #LI-Remote designation.
  • Equal Opportunity Employer status with nondiscrimination protections.
  • Reasonable accommodation support for applicants with disabilities during the application process.
  • Privacy policy and CA privacy notice protections for applicant data.

Interested in this position?

Apply directly on the company website

Apply Now

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