Regulatory Lead
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Søborg
Can you take the lead and want to work with a range of projects supporting setting up local manufacturing to both serve local needs and global supply challenges? Are you strategic around regulatory plans, experienced within regulatory CMC (Chemistry, Manufacturing and Controls) and manufacturing site approvals? If yes, then you should continue reading and consider becoming part of Novo Nordisk. We are currently looking for a Regulatory Lead to join our team and becoming responsible for our local manufacturing sites. Apply now! The position Your main responsibility will be to lead the regulatory agenda and plan for ongoing projects involving the expansion of our manufacturing capacity by establishing new manufacturing setups, both at local Novo Nordisk sites and through collaborations with CMOs (Contract Manufacturing Organizations). You will be the point of contact and person responsible for coordination of the regulatory strategy, pathway, and opportunities in accordance with regulatory guidelines and requirements. You will be expected to use your skills to: Lead regulatory agendas, apply intelligence, and develop strategies Execute on submission planning and strategies in close collaboration with all relevant stakeholders (internally in Regulatory Affairs as well as externally) Find new and faster ways of working and obtaining approvals In this position, you are expected to demonstrate leadership by setting strategic regulatory direction for high-impact projects in the area and being the strategic partner to stakeholders in the local manufacturing organisation and towards the global affiliates, while being a strong project manager keeping progress on plans and execution. The role requires the ability to work effectively with people from different functions and organisational levels, calling for high cultural awareness and the necessary skills to encourage and influence colleagues, governance, and key stakeholders. Although we prefer on-site work, we understand that some individuals may require a flexible work arrangement. With the right skills and qualifications, the perfect candidate will have the opportunity to work remotely and contribute to our team from outside of Denmark. Qualifications To be successful in this role, you need the following: Master’s degree in natural science or similar Several years of track record from a similar regulatory position, preferably experienced within CMC Proven track record with stakeholders, project management, planning, relevant health authorities and processes Hands-on experience navigating within an environment of tight timelines, high complexity, non-standards, and diverse tasks in known and new therapy areas Advanced level of written and spoken English is required In addition to the above, you also need excellent analytical skills, a systematic approach to identify root causes and propose innovative ways to solve problems. You need the ability to communicate complex scientific procedures with technical proficiency both orally and in writing, in a simplified and structured way. On a personal level, you are a dedicated team player, can build working relationships, and gain recognition amongst stakeholders with your proactiveness, integrity, and communication skills. About the department Novo Nordisk Regulatory Affairs makes medicine available to patients all over the world by ensuring fast regulatory submissions and approvals in all our global markets. You will be part of a relatively new department responsible for project management, scientific and regulatory strategic input to capacity and manufacturing projects, as well as being responsible for enabling fast approvals for world-wide roll-out and return on investment for the growing manufacturing network. We are engaged in high potential projects to support the demand of increasing capacity and flexibility in our global manufacturing network and implement newest technology. 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 to manufacturing, marketing, and sales – we’re all working to move the needle on patient care. Contact For more information, please contact Malene Østergaard Jørgensen at +45 3079 5844. Deadline 11 April 2023. Applications will be evaluated continuously when received and candidates may be called for interview before the deadline. We are looking for several Regulatory Affairs profiles at Novo Nordisk now. Therefore, hiring managers from different teams might also look at your application. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. #LI-AMS1 We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 20.3.2023, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Øvrige
- Søborg
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