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Senior Regulatory Affairs Manager

Company

Elanco

Location

Utrecht, Netherlands

Type

Full time

Responsibilities:

  • Lead the design and development of regulatory strategy and technical documents in support of global development projects.
  • Manage resources and provide technical leadership to ensure timely delivery of regulatory activities and compliance.
  • Represent the regulatory viewpoint on development teams and lead engagements with regulatory agencies in the EU or the USA.
  • Develop and maintain effective relationships with global regulatory authorities and influence industry associations.
  • Proactively identify and communicate project-specific risks and opportunities to internal stakeholders.
  • What You Need to Succeed (minimum qualifications):

  • Master’s degree or higher in veterinary medicine, biologic, infectious diseases, immunology, or a related field.
  • A minimum of 10 years of experience in the animal health industry, with direct Regulatory Affairs experience with biologics/large molecule products.<...
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