RemoteLeaf Logo
Log in Sign up

Regulatory and Start Up Specialist

1 hour, 55 minutes ago
Italy
Full-time
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 71

Description

  • Prepare Clinical Trial Application forms and submission dossiers for Competent Authorities, Ethics Committees, and other local bodies.
  • Manage submissions, amendments, notifications, and responses to CA/EC within required timelines.
  • Provide regular status updates on regulatory and ethics submissions to study leadership and project teams.
  • Maintain project plans, trackers, and regulatory intelligence tools related to assigned studies.
  • Support development of study start-up plans, IMP release requirements, and essential document review criteria.
  • Partner with site CRAs to coordinate communication and secure site activation readiness.
  • Review and manage essential documents needed for site activation and IMP release.
  • Customize patient information sheets and informed consent forms for country/site requirements.
  • Coordinate translations for study documents and related materials.
  • Communicate with feasibility, clinical operations, project management, regulatory, and site contracts teams on country start-up status and deliverables.
  • Act as a subject matter expert on critical path data points for site activation, including authority timelines, contracts, budgets, and required reviews.
  • Support budget negotiation and investigator contract execution when needed.
  • Support feasibility outreach to assess investigator interest in potential studies.
  • Keep current on local clinical trial laws and regulations and help share that knowledge internally.
  • Maintain audit and inspection readiness and file documents in the TMF according to study plans.
  • Support pre-study site visits when required.

Requirements

  • Experience working as a Regulatory and Start Up specialist in a CRO or pharmaceutical/biotech environment.
  • Experience customizing informed consent forms for Italy.
  • Bachelor’s degree in life sciences or a related field, preferably in a scientific or healthcare discipline, or Registered Nurse (RN), or equivalent education, training, and experience.
  • Experience in contracts and budgeting negotiation is desirable.
  • Strong communication and organizational skills.
  • Experience using computerized information systems, electronic spreadsheets, word processing, and email.
  • Fluency in English and the local language.
  • Ability to prioritize workload and meet deadlines.
  • Knowledge of local clinical trial laws and regulations is preferred.
  • #LI-Remote designation indicates the role is remote.

Benefits

  • Remote work arrangement.
  • Equal Opportunity Employer status.
  • Reasonable accommodation support for candidates with disabilities during the application process.
  • Privacy and applicant data protection policies provided.
  • Formal interview process before any job offer is made.

Interested in this position?

Apply directly on the company website

Apply Now

Similar Roles

ABC Legal Services

Data Entry Specialist, Remote

ABC Legal Services 251-1K Specialized Consumer Services

ABC Legal Services is seeking a remote e-File Specialist based in Indiana to review and file legal documents through online systems while supporting the e-Fulfillment and e-Filing team.

United States Full-time Entry Level Operations Specialist
$31k-$31k
10 minutes ago
Ylopo

Data Entry Support Specialist

Ylopo 51-250 Professional Services

Ylopo, LLC is hiring a Data Entry Support Specialist to support client onboarding and offboarding by accurately maintaining data across websites, databases, and internal support systems.

Philippines Full-time Entry Level Customer Support Operations Specialist
$7k-$7k
10 minutes ago
P

Business Development Coordinator

Precision AQ 1001-5000 Business Consulting and Services

Business Development Coordinator at Evidence Solutions, supporting the company’s business development operations by maintaining sales materials, coordinating internal workflows, and managing proposal-related processes.

United States Full-time Junior Business Development Operations Specialist
$70k-$90k
Salesforce
10 minutes ago
Pearce Services

Generator Refuel and Deployment Technician

Pearce Services 1K-5K Construction & Engineering

Pearce is hiring a field-based Generator Refuel and Deployment Technician to support cooling and power operations by keeping generators fueled, deployed, and ready to reduce downtime and maintain reliable service across customer sites.

United States Full-time Junior Operations Specialist
$42k-$52k
10 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