Description
Regulatory affairs Manager - CTA, 6 months contract SwitzerlandWe have a new opportunity for experienced regulatory affairs manager to be responsible for managing regulatory Clinical Trial Applications (CTA) submission activities for
assigned clinical trials.
Responsibilities:
execution of the global CTA submission strategy, as well as the quality and completeness of the CTA regulatory submissions for Clinical Trial Applications, throughout the lifecycle of the trial.
ensure that the required regulatory intelligence is in place to comply with country-specific requirements and will lead a cross-functional team (CTA Working Group that will compile, publish and produce Clinical Trial Authorization Applications and associated CTA lifecycle submissions (e.g., Health Authority responses, amendments, etc.).
submit the CTAs directly to Health Authorities, or facilitate the CTA submission by local personnel in a given country.
responsible for interactions with Health Authorities, and will be the primary contact point with regulatory authorities for communications relating to direct submissions of CTAs.
responsible for liaising with and overseeing CRO staff, as required.
Required experience:
in depth regulatory submission experience and regulatory knowledge in particular in clinical trial applications
project management and leadership skills and strong communication skills.
This is a temporary position for 6 months and could be extended.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.