Senior Regulatory CMC Professional for Late-stage Project
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Søborg
Do you dream of a career with a global pharmaceutical company built on life-changing innovations? Does working with incredibly talented and engaged colleagues from many different professional backgrounds and cultures inspire you? Do you have a flair for setting and executing RA strategies for product manufacturing process optimisations? Then you could be our new colleague in Regulatory Affairs. 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. In RA CMC Biotech & Rare Disease we are a group of ~40 highly skilled and dedicated regulatory professionals divided into three departments and involved in every Regulatory CMC aspect concerning our Rare and Other Serious Chronic Disease products. The late-stage project portfolio is growing; therefore, we are looking for an experienced profile to join us and work in projects within protein-based biologics. The position We are looking for a colleague with scientific and technical mindset to work on late-stage development and life cycle management of our antibody projects. As a Senior RA CMC professional, you are expected to the set strategic regulatory direction for global product roll out to markets and for manufacturing optimisation projects. Your key responsibility is to ensure that scientific progress is turned into regulatory pathways. Working closely together with decision-makers across multiple functions in a global environment, you thrive with the challenging reality of international communication across time zones, cultures, and circumstances. In addition, you will also be responsible for and contribute to the success of RA CMC Biotech and Rare Disease by: Applying regulatory intelligence and develop global regulatory strategy into marketing applications in major markets Drive preparation of regulatory CMC files for rest of the world Drive submission of regulatory files, response to questions from health authorities Support the planning and conduct of regulatory authority interactions. Provide input to the preparation of health authority meeting requests, meeting packages etc. Contribute to improvement projects 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. You will work in a fast-paced environment with informal atmosphere and where good humour is always welcome. This is an opportunity for you to continue your individual development and stay updated within relevant regulatory and biotech disciplines and you can expect to build an extensive internal network. Our commitment to innovation also applies to the way we work: We embrace remote work and the hybrid workplace. Whether you prefer to work from home, at the office or to blend the two to your liking. Qualifications What we expect from you: 5-7 years of relevant experience from the pharmaceutical industry preferably including min. 2-3 years regulatory CMC experience either from the pharmaceutical industry or from a medical agency A strong scientific and technical mindset, as well as a thorough understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytics, and quality assurance) Ability to communicate topics related to CMC of drug substances and drug products scientifically and professionally in your contact with colleagues and health authorities High proficiency in English As all work takes place in multidisciplinary project groups, we expect you to be a dedicated team player, find it easy to build working relationships, and gain recognition amongst stakeholders with your proactiveness, integrity, and communication skills. 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. Contact For more information, please contact Dorte Lunøe +45 3079 0217 Deadline for application 19 February 2023 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 22.12.2022, 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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