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 jblackham@ckqls.ch, 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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