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Boehringer Ingelheim
9d ago

(Senior) Manager RA(m/w/x)

Ingelheim am Rhein
Part-timeOn-siteExperienced

Description

You will drive the global lifecycle of veterinary medicines by defining CMC strategies and managing regulatory dossiers while acting as a key liaison between the organization and international authorities.

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Requirements

  • Master’s or university degree in Life Sciences
  • Initial experience in Regulatory Affairs or development
  • Understanding of pharmaceutical veterinary regulatory requirements
  • Excellent communication, negotiation and interpersonal skills
  • Excellent command of English
  • Experience in Regulatory Affairs or comparable roles
  • Knowledge of veterinary medicinal product requirements
  • Awareness of industry trends and competitors
  • High initiative and strong organizational skills

Education

Master's degree
OR
Bachelor's degree

Tasks

  • Define CMC regulatory requirements for assigned initiatives
  • Represent the RA CMC function in cross-functional teams
  • Serve as the central contact for technical and regulatory stakeholders
  • Oversee geographical expansion activities for veterinary products
  • Manage regulatory activities from submission to procedure completion
  • Liaise with the EMA and national competent authorities
  • Prepare and review quality-related documentation for dossiers
  • Support regional and local teams with product registrations
  • Develop and implement global regulatory strategies
  • Update and maintain regulatory tools and databases
  • Lead or support internal infrastructure projects
  • Engage proactively with regulatory authorities and external partners

Languages

EnglishBusiness Fluent

Benefits

Flexible Working

  • Hybrid work setup

Informal Culture

  • International and crossfunctional environment
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