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Sanofi-Aventis Deutschland GmbH
6d ago

Regulatory Site Officer(m/w/x)

Frankfurt am Main
Full-timeWith Home OfficeExperienced
AI/ML

Description

In this transversal role, you will bridge the gap between manufacturing and global health authorities to ensure life-saving biological drugs reach the market while maintaining strict regulatory compliance.

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Requirements

  • •Desirable technical pharmaceutical CMC experience
  • •Preferred 1-5 years direct Regulatory CMC experience
  • •Knowledge of global regulations and guidelines
  • •Strategic thinking for technical and regulatory issues
  • •Initiative, independent thinking, and anticipatory foresight
  • •Effective communication to internal and external audiences
  • •Ability to make decisions in moving environments
  • •Knowledge of Chemical and Biological products
  • •Skills for internal data management systems
  • •Ph.D, Master in science/health, or equivalent
  • •Fluency in German and English language

Education

Doctoral / PhD
OR
Master's degree

Tasks

  • •Assess manufacturing and control procedures for regulatory compliance
  • •Evaluate and decide on the regulatory impact of product changes
  • •Organize site meetings to manage regulatory activities
  • •Participate in global meetings regarding regulatory changes
  • •Communicate regulatory timelines and approval statuses to QA functions
  • •Provide regulatory expertise for new product introductions and technologies
  • •Advise on change management for transfer projects
  • •Write submission-ready CMC documents using optimized terminology
  • •Support worldwide marketing authorizations and site registrations
  • •Collect GMP-related documents from manufacturing sites
  • •Coordinate regulatory requests following dossier variations
  • •Prepare answers for Health Authority inquiries with site experts
  • •Act as the interface between Global Regulatory Affairs and manufacturing
  • •Collaborate on standard operating procedures with regulatory context
  • •Support continuous improvement of regulatory working processes
  • •Prepare for and participate in inspections as a subject matter expert
  • •Optimize the use of company software for regulatory management

Tools & Technologies

internal data management systemsdocumentation tools

Languages

German – Business Fluent

English – Business Fluent

Benefits

Modern Office

  • •Modern working environment

Flexible Working

  • •Hybrid working models
  • •Flexible working time models
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