For a pharmaceutical industry active in the field of vaccines, we are looking for an English speaking consultant with at least 3 years of experience in CMC writing.
The mission involves
- Definition of the strategy for the submission of technical (quality) changes
- Preparation, authoring and coordination of CMC submissions related the life-cycle maintenance of Vaccines (CMC variations, commitments, market expansions, answers to questions from world-wide regulatory authorities).
- Maintenance of regulatory dossiers.
- Interactions with regulatory and technical contributing disciplines Teams (QC, QA, Production, Supply) to ensure File content definition,
- Use of regulatory information management systems such as Documentum, Liquent, and Veeva Vault
Under supervision of a CMC manager, liaise with contributing disciplines to define technical file content
- Ensure planning and proper organization of activities (for technical/CMC and procedural aspects) in line with the overall project plan and RA 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
- Provide support to the supervisor via critical review of the technical section of regulatory documents
- Ensure liaison with and coordination between RA teams, RA management, Regulatory operations and any other stakeholders involved in the program
- Report significant issues to the management
- Life Sciences background (bachelor or master degree) or equivalent by experience.
- 2-5 years' experience in CMC RA/Technical Life Cycle Management (especially in writing CMC technical variations - Module 3)
- Experience in Vaccines is preferred
- Knowledge of systems like documentum, Viva
- Project Management skills
- English mandatory - French is an asset
- Existing right to work in Europe required.
- A balanced salary package based on your capabilities and experience.
- Meal vouchers.
Vacancy number : 18427