Regulatory Affairs Professional

The position

As a Regulatory Affairs Professional, you will have the opportunity to work within late-stage development, preparing for upcoming MAA/NDA/BLA submissions and roll out in the whole world. You will be the voice of Regulatory Affairs CMC and you will be responsible for providing scientific and strategic input to the projects you work with to obtain the regulatory approvals. You will turn your knowledge within pharmaceutical operations into regulatory pathways and develop global regulatory CMC strategies based on current legislation and regulations. You will be in the center of project planning and execution – responsible for planning, coordinating, and reviewing regulatory documentation related to the drug e.g., supporting preparation of applicable sections of submission packages, responses to agency questions for global markets and Agency Meeting Packages. More specifically, you will be accountable for: Planning, executing and driving strategic regulatory CMC activities Apply CMC regulatory intelligence to develop robust regulatory strategies Identifying as well as improving regulatory CMC practices, processes and approaches related to regulatory CMC documentation and strategies. Our commitment to innovation also applies to the way we work. We therefore embrace the hybrid workplace – with a blend of home office and on-site work preferably in Søborg, Denmark where the global RA CMC & Device department is based. Qualifications You come with a strong scientific and technical background and mindset, which you have acquired through your experience with RA and/or pharmaceutical operations – manufacturing, product supply, process development, CMC development, analytics, quality assurance and other related areas. The ideal candidate should have: Master’s degree and/or PhD in a relevant field Relevant experience within RA and/or pharmaceutical industry High proficiency in English - written as well as spoken Great communication skills as all work takes place in multidisciplinary project groups. You are a dedicated team player, find it easy to build working relationships, and gain recognition amongst stakeholders with your proactiveness, flexibility and integrity. Furthermore, you thrive in the challenging reality of international communication across time zones and cultures. About the department Novo Nordisk Regulatory Affairs CMC & Device makes medicine available to patients around the world by ensuring fast regulatory submissions and approvals in all our global markets. The RA CMC Diabetes and Obesity consist of just over forty-six highly skilled dedicated colleagues with very diverse backgrounds and experience, who are involved in every Regulatory CMC aspect concerning products and projects in these areas. As Novo Nordisk’s product portfolio is growing, we are developing and implementing highly diverse CMC solutions to the complex manufacturing processes, therefore we are looking to expand our team. Working at Novo Nordisk At Novo Nordisk, we do not wait for change. We drive it. We are a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing, and sales – we are all working to move the needle on patient care.