SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment...
...management (RIM) system.
What we expect from you:
Experience in publishing of regulatory submissions for Investigational (IND, CTA) or Marketing Applications (NDA, MAA, NDS, MAA, 510k) to Health Authorities in eCTD, NeeS, eSub or paper formats.
...Ideally track record in international regulatory affairs and biotech
products with practical experiences of registration procedures like CTA/IND
* Practical experience with CMC development and handling European and US
...with leading CMC strategic planning, preparation and execution of Agency interactions.
+ Experience leading CMC teams through IND, CTA development, and addressing Agency questions to support the start up of clinical trials.
+ Experience in leading CMC teams through...
...consent form...), together with the Medical Advisors.
+ Actively ensure the obtaining of any study related documentation required for CTA application according to local regulation and Corporate & local SOPs, together with the Support Services Manager.