DRC/Regulatory Affairs CMC Manager

DRC/Regulatory Affairs CMC Manager

Sandoz

Kundl, Austria

Your Responsibilities:

Your responsibilities include, but not limited to:

  • Contribute as Development Regulatory Center (DRC) Manager Chemistry, Manufacturing and Controls (CMC) expert to technical project teams during product development
  • Ensure alignment across global and local functions with regard to strategy and direction for timely preparation of high quality CMC documentation to support new regulatory submissions for complex new product developments and/or for a portfolio of new product development projects
  • Independently and proactively identify required documentation for submission and coordinate the availability of approved technical source documents in accordance with project timelines
  • Write high-quality CMC documentation according to agreed CMC regulatory strategies, while assuring technical congruency and regulatory compliance, to obtain rapid and advantageous registrations of new products world-wide
  • Manage/lead DRC related projects or global initiatives

Minimum requirements

What you’ll bring to the role:

  • Academic degree in life sciences (Chemistry, Biochemistry or equivalent area)
  • At least 3 years’ experience in Regulatory Affairs (with a focus on knowledge of CMC requirements)
  • Develops and presents strategic regulatory options to internal and external stakeholders
  • Demonstrates strong leadership skills, establishes (cross-functional) teams/relationships and maintains them
  • Very strong communication skills in English

Desirable requirements:

  • German skills would be beneficial
  • Knowledge of project management

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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