...regulatory- and health authorities.
This project will take 7 months minimum. Extension is likely.
ResponsibilitiesYou lead your CTA team and make sure that applications will be compiled, published and produced. You keep track of all events regarding all regulatory...
...scientific field, preferably pharmacy related
Relevant and long experience in the regulatory environment
Hands-on experience with CMC, CTA, registrations
Fluent in English, French and Dutch
Good interpersonal and organisational skills Are you interested and do want...
...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
...Providing input into process improvement initiatives
Collaborating with Study Teams in all aspects of trial document management and CTA tasks
Closely cooperates with the Director Clinical Operations on the management of the German CO department
...Ethics Committee/IRB, prepare necessary documentation enclosed to the application according to local requirements in cooperation with CTA and directed by Lead CRA/Project Manager
Participate in contract handling and negotiation directed by Lead CRA/Project Manager...