Regulatory and Start Up Specialist

1 hour, 49 minutes ago
Full-time
Mid Level
Operations
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

Description

  • Coordinate timely, high-quality site activation activities and mitigate country or site-level risks.
  • Prepare clinical trial applications and submission dossiers for Competent Authorities, Ethics Committees, and other local bodies.
  • Interact with regulatory and ethics authorities and manage responses and submission updates.
  • Maintain project plans, trackers, regulatory intelligence tools, and site activation critical-path data.
  • 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 execution of investigator contracts under the direction of Site Contract Management.
  • Maintain knowledge of local clinical trial regulations, audit and inspection readiness, and TMF filing requirements.

Requirements

  • Bachelor’s degree in life sciences or a related scientific or healthcare field, or RN/equivalent education, training, and experience.
  • Demonstrated experience negotiating contracts and study budgets in Spain.
  • Previous experience as a Regulatory or Start Up Specialist in a CRO, pharmaceutical, or biotechnology company, or equivalent relevant experience.
  • Experience with regulatory and site start-up activities, including feasibility, contract negotiations, and CA/EC/IRB submissions.
  • Fluency in English and Spanish; Portuguese fluency is strongly preferred.
  • Strong communication, organizational, prioritization, and deadline-management skills.
  • Proficiency with computerized information systems, electronic spreadsheets, word processing, and email.
  • Experience with milestone tracking tools or systems is preferred.
  • Pharmacy qualification or pharmacist experience is beneficial.
  • Advanced degree in medical or life sciences, RAC certification, or a Master’s in Regulatory Science is preferred.

Interested in this position?

Apply directly on the company website

Apply Now

Similar Roles

Operations Associate

Cision 5K-10K Professional Services

Cision is seeking a content distribution and editorial professional to process, proofread, and distribute client communications through PR Newswire channels while ensuring accurate, timely delivery and high-quality client service.

1 hour, 34 minutes ago

Senior Payment Operations Specialist

Nomi Health 251-1K Insurance

Nomi Health is seeking a Senior Payment Operations Specialist to oversee accurate, compliant payment processing and partner with Product and Technology teams to improve healthcare payment platform reliability.

HIPAA JIRA SQL
1 hour, 49 minutes ago

Financial Services Onboarding Specialist

Nomi Health 251-1K Insurance

Nomi Health is hiring a Financial Services Onboarding Specialist to guide providers, TPAs, and employer groups through compliant onboarding onto its payment and financial services platforms while ensuring accurate documentation and smooth activation.

JIRA Salesforce SQL
2 hours, 4 minutes ago

Ad Operations Specialist

Editorialist 51-250 Personal Products

The Ad Operations Specialist will support luxury brand advertising campaigns across multiple platforms, managing execution, monitoring, reporting, and client-facing materials throughout the campaign lifecycle.

Asana Facebook Ads
2 hours, 4 minutes ago

You're on a roll! Sign up now to keep applying.

Sign Up

Already have an account? Log in

Used by 14,729+ remote workers