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description de la société
You will be responsible for managing regulatory Clinical Trial Applications submission activities for assigned clinical trials (Phase 1 - Phase 4 spanning five therapeutic areas Oncology, Neuroscience, Cardiovascular and Metabolism, Immunology, and Infectious Disease).
Do you believe in affordable healthcare? Are quality & safety your priority number 1? Then you'll feel comfortable in this company, who's one of the biggest pharmaceutical companies in the world.
We're looking for an Clinical trial regulatory leader with experience in clinical trials.
Just apply here for this challenging opportunity: email@example.com or 03 369 19 80.
description de la fonction
Do you have experience in regulatory and clinical trails? Then this is the function for you!
You will 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.).
You are responsible for interactions with Health Authorities, and will be the primary contact point with regulatory authorities for communications relating to direct submissions of CTAs.
You manage the Output Protection Process for assigned trials and ensures that key events related to the regulatory aspects of clinical trials are tracked in the company-own tracking system.
Identifies and proactively responds to issues, problems, or opportunities as it relates to the leading the CTA workgroup.
Makes decisions independently for day-to-day activities of CTA workgroup.
You have a science degree (bachelor/ master/ PhD)
You have knowledge of scientific terminology and drug development
You have experience of regulatory affairs within the pharmaceutical industry
You have strong communication skills and project management skills.
As an answer to your high performance & flexibility, Ausy offers you an interesting salary package, with some interesting extra's like:
Meal vouchers of €7
Net representation cost of €50
Car + unlimited fuel card OR home-work compensation
Opportunities to follow trainings
And on top of this you'll improve your administrative skills and become an even bigger expert!