Global Regulatory Affairs Senior Manager
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.
