Description du poste
You will join EXTIA as a regulatory affairs specialist and be part of a team coordinated by yourmanager. Together you will design technical and management solutions for our clients in thepharmaceutical industry.
You will be present on the client’s plant to work on mid and long termprojects. As a regulatory affairs specialist you will be working in a team of consultants who areexperts in the Pharmaceutical industry.
As a regulatory affairs specialist, you will be responsible for :
Activities regarding the review and updating of regulations
Review and classify licensed / restricted regulated materials
Generating & maintenance of applicable regulated material SOPs & programs
Applicable regulations and evaluates their impacts on the business, and propose guidance,procedures, programs & policies
Acting independently and recognizing important regulations & changes involving compliance
Performing other duties as assigned
You have received an engineering degree or equivalent.
You know the legal requirements for pharmaceutical industry (cGMP)
You have proven experiences in one of those above roles
You are proactive, have good communication skills, and are able to change people mind-set in theway of efficient working.
You are proficient in French and English (written, spoken)!