Regulatory Affairs Manager (CMC) - Biotech

On Application
08 Jan 2019
08 Feb 2019
Contract Type

Your tasks:

  • Planning and preparation of documents for the approval of biotechnology drugs in USA and Europe with focus on CMC (eg Briefing Books, IND / IMPD, CTD Module 3, answering questions from the regulatory authorities)
  • Coordination and execution of regulatory activities for our development programs with the departments involved (development, quality control and quality management) and in cooperation with our licensing partners
  • Participation in project teams and contacts to external partners and contract manufacturers in regulatory issues
  • Control, processing and approval of the documentation of contract manufacturers as well as internal development reports
  • Development and implementation of regulatory strategies and support for tech transfers of biotechnological active substances
  • Regulatory compliance checks and evaluation of changes
  • Ensuring compliance with relevant regulations and regulations

Your qualification:

  • Natural science degree, preferably biology, biotechnology, pharmacy or chemistry or related field
  • several years of experience in drug approval in the US and Europe
  • Practical experience in creating CMC Drug Substance documents for BLA / MAA submissions
  • Sound knowledge of the requirements for the development and production of biotechnological active ingredients
  • Preferably experience with tech transfer projects
  • Ideally, knowledge of the EMA / FDA guidelines and requirements for the development of biosimilars
  • Enthusiasm and creativity for the design of a biopharmaceutical company
  • Safe German and very good English language skills
  • Independent, careful, structured way of working
  • teamwork

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