Job Description and Duties
For 17 years, the largest laboratories have renewed their trust in us. Specialized in pharmaceuticals, biotechnology and medical devices, we support our customers from research to the marketing of their products.
A company on a human scale, we are committed to supporting and personally advancing nearly 600 employees recognized for their technical and scientific expertise. Through our regional subsidiaries, we guarantee everyone geographic stability, with no mobility clauses in the main areas of activity in France, Belgium, Switzerland and Canada.
At Consultys, we prove that it is possible to match Human and Performance.
Much more than concepts, our 3 values ”Respect, Recognition and Transparency” guide us and are the foundation of our history, the heart of our group’s success.
As part of the expansion of regulatory activities, CONSULTYS is recruiting on a permanent contract a Chemistry, Manufacturing and Controls (CMC) (F/H) Regulatory Affairs Officer for one of its clients. You will be responsible for the following activities:
Preparation and submission of technical files (module 3) in CTD format (CMC regulatory requirements): registration files, variation files,
Preparation of MA renewal files,
The management of the files of answers to the questions of the authorities,
Participation in FDA, ANSM audits, etc.
The position is to be filled as soon as possible in the Lyon region.
Desired profile: * You are an engineer or university graduate (Bac + 5) and you have 2 years of experience in regulatory affairs in the pharmaceutical industry, * You know the associated standards (BPF, GMP), * Are you fluent in spoken and written English? * Mastery of regulations (CEP, DMF, JDMF, …) regarding marketing authorization files, * You demonstrate good organizational and relational capacity and good rigor, — Want to to integrate the universe of the council within a company with human size valuing the individual and the performance? To invest in innovative projects for the long term? To share your skills within a close-knit team where experiences are shared freely? So Join Us! CONSULTYS is open to all talents and is committed to diversity and the inclusion of people with disabilities.
