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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
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