Global Regulatory Affairs Senior Manager

  • Salary: Competitive
  • REF Number: 00048038
  • Consultant: Jocelyn Blackham
  • Contact: 0041 (0) 782 516 595
  • Date Published: 07.04.2020
  • Sector: Oncology, Anti-Infectives
  • Location: Lausanne Region
  • Discipline: Clinical - Regulatory Affairs

CK QLS are recruiting for a Senior Manager with Global Regulatory Affairs to join a successful biopharmaceutical company at their site based in Lausanne in the Canton of Vaud on a permanent basis.

Company: This company is an expanding biopharmaceutical company with a global presence.

Location: This Global Regulatory Affairs, Senior Manager role will be based at our client's site in Lausanne.

The Role: Responsibilities of the successful Global Regulatory Affairs, Senior Manager will include:

  • Implementing regulatory strategies spanning from first-in-human studies up to registration, including support to out-licensing activities.
  • Leading and/or supporting the Regulatory Affairs core-team representative in coordinating the timely preparation of several submissions, providing guidance to the teams in defining the best strategy for each submission.
  • Managing regulatory CROs in charge of publishing and performing local submissions.
  • Reviewing and contributing to the approval of Clinical Study Protocols, Clinical Study Reports, Statistical Analysis Plans, DSURs, and other documents of regulatory relevance.

Your Background:

  • Bachelor's degree in Health/life-sciences, higher qualification would be advantageous.· Previous experience within a Regulatory Affairs role is essential. Global experience desired.
  • Demonstrated regulatory knowledge and experience in early phases of development is essential. Experience in Phase III-IV development, would be beneficial.
  • Experience working with antibacterial or oncology drug development is preferred.
  • Excellent written and communication skills in English. Knowledge of French is beneficial.

Apply: For more information or to apply for this Global Regulatory Affairs, Senior Manager, please contact Jocelyn on 0041 (0) 782 516 595 or email, quoting job ref 48038.

Please send all of your correspondence in English.

It is essential that applicants hold entitlement to work in the country where the services will be delivered.

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