For one of our clients, located in Wavre, we our currently looking for 2 "CMC Writers".
The Technical RA manager is responsible for the preparation, authoring and coordination of CMC submissions related to China Compliance remediations program. The person will also be required to interact with regulatory and technical contributing disciplines Teams to ensure File content
definition, submission strategy and preparation coordination.The positions will be initially for a twelve month period and would be based in Waver, Belgium.
- Under supervision of a manager liaise with contributing disciplines to define technical file content and submission strategy related to China compliance remediation dossiers
- Ensure coordination of activities related to CMC submission file preparation, including change control assessment, source documents collection from key contributing discipline (eg GIO,QC, Site Conformance, etc), initiation and management of CMC submission kick-off meeting,file authoring, review and approval.
- Ensure liaison with and coordination between RA teams, RA management, Regulatory operations and any other stakeholders involved in the program
- May provide technical regulatory inputs and advice to technical steering committees related to China compliance program, as appropriate
- Together with Regulatory product responsible, agree on File preparation and submission planning; monitor progresses and take any remediation actions in case of deviations.
- Report significant issues to the management.
Do the above responsibilities fit you like a glove?
Upload your CV and motivation letter via the "apply now" button and you can expect feedback from us soon.
If something is not entirely clear, you can reach out to us by telephone of course.
- Life Sciences background is preferred or equivalent by experience.
- Knowledge of regulatory procedures / systems / guidance's
- Knowledge & experience of Technical Life Cycle Management and Change Control process
- Knowledge of biological products
- Good level of spoken and written English. Knowledge of French is an asset Experience (ar. 10 y)
- Experience in Project Management
- Experience in CMC authoring of technical file
- Experience working with Biologics (if possible preferred over Pharmaceuticals)
- Experience in China legislation would be a plus Skills
- Manages own time to meet agreed short-term targets. Ability to clearly identify priorities and manage multiple tasks
- Good communication skills
- Analytical skills, creative and critical mind
- Team player
- A balanced salary package based on your capabilities and experience, including mealvouchers.
Existing right to work in Europe required ( please read job spec in full before applying ).
Vacancy number: 16695