18 days ago on career012.successfactors.eu

Manager, CMC Biotech Regulatory Affairs

Merck Gruppe

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 Please refer to JobSuchmaschine in your application

Manager, CMC Biotech Regulatory Affairs

Merck is a leading science and technology company in healthcare, life science and performance materials. Around 50,000 employees in 67 countries work to further develop technologies that improve and enhance life – from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions.


You role:Support regional Health Authority interactions. Accountable to support the preparation of the Briefing Books and develop the strategic outline. Ensure that development project strategy incorporates the outcome of consultations with regulatory authorities. Ensure understanding of the external regulatory competitive and intelligence environment to adapt the global regulatory strategy for the quality sections accordingly in projects/products. Develop and drive the execution of activities required to meet regional Health Authority expectations in target regions in line with the Global Regulatory Strategy and the international Development Plan (iDP) in collaboration with CMC Development. Manage, plan, write and update documents for the quality section which form the basis of worldwide submissions such as IND/IMPDs, new marketing applications. Plan, author, coordinate review of answers to questions from the Health Authorities regarding the Quality section.


Who you are


  •  Degree in a Life Science or related discipline (minimum MSc or equivalent degree), higher degree preferable (e.g. PhD in a scientific discipline)
  • Minimum of 6 years of pharmaceutical industry experience, with at least 3 years of global CMC regulatory experience
  • Knowledge of clinical trial development phases, IND/IMPD requirements
  • Ability to support development and implement  regulatory strategies and quality sections of regulatory documentation
  • Experience in preparation and management of regulatory documentation, normally a full international submission (new product application or large variation)
  • Knowledge and practical experience with New Biological Entities
  • Practical experience in process and product development in at least one of the following area : manufacturing process development, scale-up, comparability and validation or analytical development and validation or quality management
  • In-depth knowledge of global pharmaceutical legislation
  • Experience of interactions with Health Agencies would be an asset


What we offer:Your possibilities to develop in our growing company are just as manifold as our product portfolio. We offer a modern and international working environment to unleash your innovative potential in diverse teams, and take responsibility for our employees, products, the environment and society.


Curious? Apply and find more information at come2merck.com