Role DescriptionJanssen Research & Development develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.
ResponsibilitiesAs Global Regulatory Affairs specialist you contribute to the development of global Chemistry, Manufacturing and Control (CMC) regulatory strategies and content plans. Your primary responsibility is to support the regulatory activities related to vaccines in Europe and US, and specifically to support the preparation of a MAA and BLA. You will support CMC Teams and provide direction on the interpretation and application of CMC regulations and guidances related to vaccines. Additional responsibilities include: contribute to the preparation and editing of clinical trial applications that include vaccines
Requirements- MSc degree in biological, pharmaceutical, or chemical sciences - 5-8 years of experience inclusive of post graduate education and/or pharmaceutical or health care industry experience. - At least 5 years of experience in CMC-Regulatory Affairs is required - Knowledge of vaccines required - Strong knowledge of EU and FDA regulations is required. - Demonstrated ability to manage multiple tasks/projects/priorities and complex systems simultaneously is required. - Direct and significant regulatory experience with vaccines and in CMC documentation preparation for late phase INDs and IMPDs, BLAs and MAAs for vaccines highly preferred. - Experience in supporting Health Authority meetings (FDA, EMA and national agencies) preferred.
Other informationLocation flexible, however must be in Leiden 1x per week minimal, and flexible to come 3-4 days in first 2~ months during training.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Cees Roffelsen.