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Regulatory and Start Up Specialist (Portuguese speaker)

6 hours, 25 minutes ago
Spain
Mid Level
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 75

Description

  • Coordinate timely, high-quality site activation readiness and mitigate country or site-level risks.
  • Prepare and submit clinical trial applications, submission dossiers, amendments, and notifications to Competent Authorities, Ethics Committees, and other local bodies.
  • Interact with regulatory authorities and ethics committees and manage responses.
  • Track submissions, approvals, project plans, milestones, essential documents, and regulatory intelligence.
  • Develop or support study-specific start-up plans, IMP release requirements, and essential document review criteria.
  • Coordinate collection and review of essential documents required for site activation and IMP release.
  • Customize patient information sheets and informed consent forms and coordinate document translations.
  • Collaborate with CRAs, feasibility, clinical operations, project management, regulatory, and site contracts teams.
  • Support site budget negotiations and investigator contract execution when required.
  • Maintain knowledge of local clinical trial regulations, audit and inspection readiness, and applicable TMF filing requirements.

Requirements

  • Bachelor’s degree in life sciences or a related field, or Registered Nurse qualification, or equivalent education, training, and experience.
  • Experience as a Regulatory or Start Up Specialist in a CRO, pharmaceutical, or biotechnology company, or equivalent relevant experience.
  • Demonstrated experience with regulatory submissions, contracts, and budget negotiations in Spain.
  • Fluency in English and Portuguese.
  • Strong communication, organizational, and prioritization skills.
  • Experience with computerized information systems, spreadsheets, word processing, and email.
  • Experience with regulatory and site start-up activities, including feasibility, contract negotiations, and CA/EC/IRB submissions.
  • Experience using milestone tracking tools or systems.
  • Pharmacy qualification or pharmacist experience is highly beneficial.
  • Advanced medical or life sciences degree, RAC certification, or Master’s in Regulatory Science is preferred.

Benefits

  • Remote work opportunity.
  • Equal opportunity employment and reasonable accommodation support for applicants with disabilities.

Interested in this position?

Apply directly on the company website

Apply Now

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