Senior Regulatory Affairs Associate
The European Center for Cardiovascular Research (CERC) is a CRO specialized in the design and management of international clinical trials dedicated to cardiovascular diseases.
Chaired by four interventional cardiologists, actors of clinical research for over 20 years, the CERC conducted clinical studies directly in line with the issues of cardiologists practicing in private or public hospitals.
CERC is currently supporting thirty studies for industrial promotions but also manages more than 10 “investigators initiated trials” whose purpose is the treatment of conditions / comorbidities for which there is no satisfactory therapeutic strategy.
CERC is currently looking for a Senior Regulatory Affairs Associate.
You will be in charge of th Management of worldwide regulatory aspects of the CERC clinical studies and contribution to the maintenance of the CERC Quality and Process Management System, including:
- Ensuring that clinical studies applications are conducted according to local and international requirements/procedures
- Coordination and performance of the submission packages to CA and EC until approval
- Providing technical and regulatory expertise for the preparation of documents to be submitted
- Performance of regulatory intelligence, in collaboration with the Clinical Operations Manager
- Contribution to the maintenance of the CERC Quality and Process Management System
- Degree in Scientific/Healthcare discipline
- Significant regulatory submission experience
- Professional English
- Good computer skill
The position is available immediately and is based in Massy, Essonne (91), France
12 reasons for joining us👉 https://www.cerc-europe.org/12-reasons/