Regulatory Affairs Manager M/F

Tasks

Aixial Group, CRO (Clinical Research Organization), specialized in Life Science. We work with laboratories to provide technical support on clinical projects from phases I to IV and post market.

Since 2014, we have been part of the Alten family. We are developing our activities in France, Belgium, Germany, Czech Republic, Denmark, UK, US...with even more prospects for expanding internationally.

We are currently looking for Regulatory Affairs Manager.

Principal Responsibilities:

• Definition of the strategy for the submission of technical (quality) changes
• Liaise with contributing disciplines to define technical file content
• Ensure planning and proper organisation of activities (for technical/CMC and procedural aspects) in line with the overall project plan and Regulatory Affairs milestones
• Compile/write high quality project/product specific regulatory documents to be submitted to authorities (for technical/CMC and procedural sections) and ensure that those documents meet regulatory requirements.
• Ensure coordination of activities related to CMC submission file preparation, including change control assessment, source documents collection from key contributing discipline, initiation and management of CMC submission kick-off meeting, file authoring, review and approval
• Ensure liaison with and coordination between Regulatory Affairs teams, Regulatory Affairs management, Regulatory operations and any other stakeholders involved in the program

Requirements

Desirable Work Experience, Qualifications and Knowledge:

• Bachelors level or above degree in Life Sciences
• At least 3-5 years of experience in CMC Regulatory Affairs and Technical Life Cycle Management
• Experience in project management
• Experience in change control process
• Knowledge of regulatory procedures, systems and guidances
• Knowledge of Technical Regulatory Life Cycle Management
• Knowledge of biological products

Langage skills:

• Fluent in English
• Knowledge of French would be an asset