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Technical Regulatory Writer (CMC)

  • Location:

    Wavre

  • Contact:

    Aurélie Petit

  • Job type:

    Permanent

  • Contact phone:

    +32 2 588 16 02

  • Industry:

    Pharmaceutical

  • Contact email:

    aurelie_petit@oxfordcorp.com

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