Description

Are you passionate about ensuring fast and successful regulatory submissions and approvals for life-saving medicines? Do you possess a natural interest and flair for regulatory guidelines combined with ? extensive experience in Regulatory Affairs (RA), Chemistry, Manufacturing, and Controls (CMC), Quality Assurance (QA), Quality Control (QC) or other relevant areas? We are looking for a Senior Regulatory Affairs CMC Professional to join our successful team in Regulatory Affairs CMC & Device and support our work across different stages of projects in different indications. If you are ready for a challenging and rewarding career in the field of RA and quality, read on! And apply now today for a life-changing career! The Position As a Senior Regulatory Affairs CMC professional, you will provide the key connection between scientists and regulators to make medicines available to patients around the world by ensuring fast and successful regulatory submissions and approvals in all global markets. You will join an organization where your long-term opportunities are vast, and there are possibilities to gain experience and hands-on knowledge with various phases of product development. For this specific position, you will be joining a team of highly skilled and motivated colleagues working on different work streams centered on the roll-out phase. This phase involves the careful implementation of regulatory strategies, ensuring compliance with relevant guidelines and standards. Effective communication with stakeholders, as well as monitoring and addressing any emerging issues, is essential for a successful roll-out. Operating as a senior RA CMC professional you will be in the center of project planning and execution – responsible for participating in establishing realistic – and at times bold – RA strategies. You will be responsible for handling national submissions and following Questions and Answers, substantial variations, and potentially also play a part in submitting new marketing authorization applications. You will be a member of the RA CMC project team and work closely together with the RA CMC Product Lead. In the team, you will participate in the planning and ensure timelines are met for your focus areas. In addition, you will also be part of an project core team, where you will be responsible for giving input from the RA CMC perspective and participating in establishing submission timelines and support decisions and discussions on what is needed for a filing to receive Healthcare Administration approval. Additional aspects of the role include identifying as well as improving regulatory RA CMC practices, processes, ensure the team works compliantly (e.g., participate in the GxP work within the RA CMC project team) and approaches related to regulatory CMC documentation and strategies. Qualifications You come with a scientific background and mindset, which you have acquired through your extensive experience in 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 Substantial work experience within the pharmaceutical industry High proficiency in English – written as well as spoken Great communication skills as all work takes place in multidisciplinary project groups A pro-active, positive, and friendly professional style combined with ability to thrive being part of a diverse team You are a dedicated team player; you find it easy to build working relationships and gain recognition amongst stakeholders with your proactiveness and integrity. Furthermore, you thrive in the challenging reality of international communication across time zones and cultures. About the Area and Department RA CMC & Device consists of six areas with three working specifically with RA CMC functionality. We are skilled, collaborative, friendly, and dedicated colleagues with diverse backgrounds and experience, and you will be part of a dynamic and committed organization handling many projects in different phases of development. Also, as Novo Nordisk’s product portfolio grows, RA CMC & Device is also looking into developing innovative solutions to increasingly complex CMC manufacturing strategies and regulatory requirements. There is focus on supportive onboarding, flexibility, empowerment, and individual development in the area. Well-being and psychological safety are also a major focus and are considered essential for the working environment. We strive for a modern way of working, including friendly colleagues, camaraderie, and space to be proactive, to learn, and to take the initiative to improve and make a difference. We want it to be the best place to work – not only in words, but we walk the talk in this area. 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. Working at Novo Nordisk At Novo Nordisk, we don’t wait for change. We drive it. We’re 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’re all working to move the needle on patient care.