Technical Regulatory Writer (CMC)

Conteúdo do emprego

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.

Job description
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

Responsibilities
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

Profile

• 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.

Benefits

• A balanced salary package based on your capabilities and experience.
• Meal vouchers.

Vacancy number : 18427