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Senior Regulatory Affairs Manager EU – Biologicals (m/f/d)

any location in Europe or Remote, any location in Europe or Remote · Biotech/Pharmaceutical
Our client is a world's leading animal health company with more than 10,000 employees worldwide. With over 65 years of tradition, they develop products and services to improve the health and well-being of pets and farm animals in over 90 countries.
To strengthen their team remotely or at any location in Europe we are currently looking for a
Senior Regulatory Affairs Manager EU – Biologicals (m/f/d)
Your responsibilities:
  • Provide regulatory expertise for veterinary biologicals
  • Regulatory affairs representation in innovation projects and life cycle management projects
  • Support to R&D project teams in regulatory and clinical aspects of vaccine development
  • Provide global strategic regulatory oversight and assign regulatory accountability
  • Create initial full registration documentation for Region EU and Most of the World (MoW) countries
  • Lead initial registration procedure in Region EU for new biologicals
  • Support Life Cycle Management group (LCM) in updates of clinical registration documentation for Region EU
  • Maintain and extend relationships across disciplines and regulatory agencies, industry groups and academia
Your profile:
  • Academic degree in biological or related sciences
  • 2-5 years of experience in research and development as well as licensure of biologicals internationally
  • Strong understanding of EU regulatory legislation and of veterinary biologicals
  • Knowledge of animal health
  • Excellent interpersonal and communication skills
  • Good scientific writing skills
  • Adequate planning and organisation skills
  • Fluent in English, second language spoken in the EEA preferred
The offer:
  • Permanent role with a top employer
  • Very attractive salary
  • International work environment with challenging tasks
  • Engaging and inspiring culture with “Play to Win” mentality
Please use our online-application form only for applying to advertised positions. Please note that we can´t consider applications that we receive by e-mail.
Andreas Dürr, E-Mail: aduerr@antal.com, Tel. 0911/59059644

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