CMC Manager (4499)

☞ CTC Resourcing Solutions

Ver: 136

Dia de atualização: 24-04-2024

Localização: Zürich Zürich ZH

Categoria: Farmacêutico / Químico / Biotecnologia

Indústria:

Tipo de empregos: Durée indeterminée

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Conteúdo do emprego

Our Client is a leading Medical Technology company for Class III Medical Devices. It is headquartered in Germany and has a global network of production sites, subsidiaries and commercial partners. For our client, we are looking for a CMC Manager for Switzerland

Purpose: You will be responsible for regulatory support for new and change projects, supporting the approval process, creating drug quality-related documents for CE marking submissions and worldwide registrations.


Responsibilities:

  • Write and update the Modules "Quality Overall Summary" and "Quality" of the CTD in collaboration with the units responsible for Formulation, Pharmaceutical and Process development, Production

engineering and Analytical Quality Control

  • Generate other modules of the CTD or summaries as required for specific submissions in collaboration with the applicable Groups and Departments
  • Prepare answers to the questions raised by authorities for high effort registration countries (e.g. USA, Australia, Canada, Japan) related to the medical substance
  • Act as a team member responsible for CMC related aspects in combination product development projects
  • Prepare answers to the questions raised by the Health Authorities and Notified Bodies following the submission of Clinical Trial Applications or CE marking submissions in collaboration with the

Regulatory Affairs Manager

  • Ensure consistency between raw data and registration documents contents
  • Interact with external suppliers of drug substances and excipients
  • Manage the regulatory assessment and the submission of drug-related changes to combination products and other changes

Qualification:

  • Experience with the submission of drugs and/or combination devices and associated regulatory assessment of variation/changes
  • At least + 3 years of experience in a similar position in the pharmaceutical industry or in medical device industry working with combination products
  • University degree in Pharmacy, Chemistry, Biology or comparable education
  • Excellent knowledge of the applicable regulations and ICH Guidelines
  • Documented training and experience in writing and updating the relevant sections of the CTD
  • Proficiency in the English language is required, good German is an asset
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Data limite: 08-06-2024

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