Clinical Trial Regulatory Leader

14-10-2019 beerse
company profile

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: anais.bosmans@cx.ausy.be or 03 369 19 80.

job description

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. 



your contribution

  • 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.

 

what do we offer?

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
  • Hospitalization insurance
  • Car + unlimited fuel card OR home-work compensation
  • 32 holidays
  • End-of-year bonus
  • Pension plan
  • ECO vouchers
  • Opportunities to follow trainings

And on top of this you'll improve your administrative skills and become an even bigger expert!

summary
function
project manager (m/f)
employment type
full time, freelance
contract type
immediate permanent employments
reference
CXRSP-85926
your Randstad contact
Anaïs Bosmans
Anais_Bosmans@cx.ausy.be 03 200 28 01
03 200 28 01