RemoteLeaf Logo
Log in Sign up

Regulatory and Start Up Specialist

1 hour, 56 minutes ago
Germany
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 49

Description

  • Prepare clinical trial application forms and submission dossiers for Competent Authorities, Ethics Committees, and other local bodies.
  • Manage initial submissions, amendments, and notifications within required timelines and local regulatory requirements.
  • Interact with Competent Authorities and Ethics Committees and coordinate responses to their questions or requests.
  • Provide regular status updates on submissions and deliverables to the Start Up Lead, Regulatory Lead, 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 assigned site CRA and other key functions to ensure alignment, document collection, and site activation readiness.
  • Customize and coordinate translation of country- and site-specific Patient Information Sheets and Informed Consent Forms.
  • Track critical path data for site activation, including authority timelines, site contracts, and budget negotiation requirements.
  • Maintain audit and inspection readiness and file documents in the TMF according to study plans.

Requirements

  • Experience working as a Regulatory/Start Up Specialist in a CRO or pharmaceutical/biotech environment.
  • Experience customizing informed consent forms for Germany.
  • Bachelor’s degree in life sciences or a related field, ideally in a scientific or healthcare discipline, or RN/equivalent experience.
  • Experience in contracts and budget 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.

Benefits

  • Remote work indicated by the #LI-Remote designation.
  • Opportunity to join a growing global clinical research organization.
  • Work on precision medicine studies across rare diseases, oncology, and other therapeutic areas.
  • Equal opportunity employer status.
  • Reasonable accommodation support for candidates with disabilities.

Interested in this position?

Apply directly on the company website

Apply Now

Similar Roles

Relativity Space

Senior Manufacturing Engineer, Turbomachinery

Relativity Space 251-1K Aerospace & Defense

Relativity Space is hiring a Turbomachinery/Propulsion Manufacturing Engineer to help develop, manufacture, test, and deliver Aeon-R engine turbopump hardware for the Terran R launch vehicle.

United States Full-time Senior Operations Specialist
$130k-$166k
11 minutes ago
Anduril Industries

Lead Production Technician

Anduril Industries 1K-5K Aerospace & Defense

Anduril Industries is hiring a Lead Production Technician to oversee the fabrication, assembly, integration, and testing of complex electro-mechanical and avionics systems for its Fury defense product.

United States Full-time Lead Operations Specialist
$52k-$69k
11 minutes ago
Versaterm

Document Imaging Technician

Versaterm 51-250 Internet Software & Services

Versaterm is seeking a Document Imaging Technician to convert physical documents into accurate digital records for public safety and related organizations under close supervision.

United States Full-time Entry Level Operations Specialist
11 minutes ago
Alphasense

Compliance Analyst

Alphasense 51-250 Industrial Conglomerates

AlphaSense is hiring a Compliance Analyst for its India Compliance Review team to help review expert call transcripts and maintain compliance across global operations.

India Full-time Junior Compliance Manager
26 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