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Global Regulatory New Product Development Manager

  • Job type: Permanent
  • Location: Zürich
  • Salary: Negotiable
  • Job reference: 352513/001_1539181058
  • Sector: Pharmacology, EPM Scientific
  • Date posted: 10/10/2018

A leading global pharmaceutical company is currently looking for a Global Regulatory New Product Development Manager to join their growing Regulatory Affairs team.

They are looking for an experienced regulatory affairs professional with experience in product development as well as a highly consultative approach. In this global role you will be leading different projects and teams in a cross functional environment.

Responsibilities:

  • Understand and evaluate a proposed product concept to provide the best possible product for the customer and increase Probability of Technical Success

  • Collaborate with New Product Value Analysis (NPVA), Research and Development Teams, and Global Marketing to develop and maintain draft launch labels (DLL)

  • Provide regulatory and technical overview of submissions (dossiers / non-CMC technical sections) pertaining to a product's approval

  • Develop and Design a creative Regulatory strategy for the organization

  • Lead the preparation and execution of project meetings (pre and post approval) with regulatory authorities as well as other external partners/customers

Candidate:

  • Minimum 7 years of regulatory and clinical experience ideally within Animal Health

  • Experience with Product Development

  • Experience with non-CMC submissions is highly wanted

  • Excellent English is a must

  • Exceptional influencing and communication skills

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