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Regulatory and Start Up Specialist

2 hours, 35 minutes ago
Spain
Mid Level
Compliance Manager
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 152

Description

  • Ensure timely, high-quality site activation readiness for assigned country sites and identify or mitigate activation risks.
  • Prepare Clinical Trial Application Forms and submission dossiers for Competent Authorities, Ethics Committees, and other local bodies.
  • Manage responses and communications with Competent Authorities and Ethics Committees for study purposes.
  • Provide regular updates on CA and EC submissions to the Start Up Lead, Regulatory Lead, Project Manager, and project team.
  • Maintain project plans, trackers, and regulatory intelligence tools related to 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 activation activities.
  • Review and manage collection of essential documents required for site activation and IMP release.
  • Customize patient information sheets and informed consent forms for country and site requirements.
  • Coordinate translations of study documents and maintain communication with feasibility, clinical operations, project management, regulatory, and site contracts teams.
  • Act as subject matter expert on site-level critical path items, including authority timelines, IRB/EC timelines, and site contract and budget negotiation requirements.
  • Support negotiation of study budgets and execution of investigator contracts when required.
  • Support feasibility activities, including site outreach to assess investigator interest in potential studies.
  • Maintain awareness of local clinical trial laws and regulations and share this knowledge within the organization.
  • Maintain audit and inspection readiness and file documents in the relevant TMF.
  • Support the clinical team with pre-study site visits when needed.

Requirements

  • Bachelor’s degree in life sciences or a related field, ideally in a scientific or healthcare discipline, or Registered Nurse (RN), or equivalent combination of education, training, and experience.
  • Qualification in Pharmacy or experience as a Pharmacist is highly beneficial.
  • Demonstrated experience in contracts and budget negotiation, specifically for Spain.
  • Experience working as a Regulatory or Start Up specialist in a CRO, pharmaceutical, or biotech environment is desirable.
  • Strong communication and organizational skills.
  • Experience using computerized information systems, electronic spreadsheets, word processing, and email.
  • Fluency in English.
  • Relevant regulatory and site start-up experience, 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.
  • Advanced degree in medical or life sciences, such as MD, PhD, or 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 and California privacy notice provided for applicant data protection.

Interested in this position?

Apply directly on the company website

Apply Now

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