CK QLS are recruiting for an Associate Director, Global Regulatory Affairs to join a successful biopharmaceutical company at their site based in Lausanne in the Canton of Vaud on a permanent basis.
This company is an expanding biopharmaceutical company with a global presence.
This Associate Director, Global Regulatory Affairs, role will be based at our client's site in Lausanne.
Responsibilities of the successful Associate Director, Global Regulatory Affairs will include:
Defining the Global RA strategy (FDA, EMA, China, Japan, etc.) for assigned projects and lead its implementation.
Leading and coordinating submissions, including INDs/CTAs, Briefing Documents to support meetings with Health Authorities in several jurisdictions, Orphan Drug Applications, PIP/PSP, Fast Track/Breakthrough Designation/PRIME, etc.
Managing regulatory CROs in charge of publishing and performing local submissions.
Serving as the primary interface for FDA/EMA on assigned projects and prepare the team for meetings with FDA/EMA and other Regulatory Agencies.
Bachelor's degree in Health/Life-Sciences, higher qualification would be advantageous.
Previous experience within a Regulatory Affairs role is essential. Global experience desired.
Thorough knowledge of the drug development process with demonstrated experience in multiple development phases.
Experience working with antibacterial or oncology drug development is preferred.
Excellent written and communication skills in English. Knowledge of French is beneficial.
For more information or to apply for this Associate Director, Global Regulatory Affairs, please contact Jocelyn on 0041 (0) (phone number removed) or email [...], quoting job ref 48037.
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.