Belgique 01.10.2020

CMC Writer

Tasks

Key responsabilities

- Participate in cross-functional meetings and discussions with regard to manufacturing and Quality Control changes related to vaccine antigens with the aim to provide regulatory advice (on submission requirements, classification and strategy) on proposed changes
- Provide input into the content of CMC sections of product specific documents for submission to regulatory agencies worldwide and ensure that these documents meet high scientific standards and regulatory requirements.
- Contribute to the writing of CMC sections of regulatory dossiers
- Ensure the planning, dispatch, submission, follow-up and approval of CMC data-packages to Regulatory Authorities
- Provide expert regulatory advice to stakeholders (manufacturing, QC) on technical changes: analyse regulatory impact and propose regulatory strategy in liaison with Company line manager
- Ensure the preparation (input, oversight and potential writing) of high quality CMC sections of regulatory documents for submission to Authorities for the product-line
- Coordinate and interact with the internal stakeholders (manufacturing and qualtiy experts regulatory group) for the preparation of submission documents and data-packages in order to meet the submission timelines

Requirements

Education : Pharmacist or Master Degree or Ph.D. in the area of Pharmacy, Chemistry, Biology or Medicine with an experience

 

  • 1-2 years RA experience in the pharmaceutical industry
  • Knowledge and understanding of regulatory legislation and guidelines related to CMC, procedural and administrative aspects.
  • Previous experience in writing scientific / regulatory documents.
  • Experience in preparation of cover letters, application forms, letters of intent and involvement in CTD Module 1 would be a plus
  • Team working skills, including optimal reporting and alerting capabilities
  • Skills in the management of IT Tools ( Regulatory databasis, Documentum like tool) , Working English
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