Head of RA CMC Semaglutide Injectables
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Søborg
- Regulatory
- Søborg
Join a fast-changing environment where engaged people do their best every day to get Novo Nordisk medicine and devices approved globally. Our people have a unique combination of scientific insight and the ability to navigate many agendas and stakeholders. This makes Regulatory Affairs a truly interesting place to work – but also quite challenging. Are you up for this challenge?
About the department
You will head up the RA CMC Semaglutide Injectables team consisting of 9 colleagues and be part of the RA CMC Diabetes and Obesity area where 22 colleagues are working in two departments. You will report to the Director of RA CMC Diabetes and Obesity and become member of the VP area, RA CMC & Device, leadership team.
Our primary responsibility is to provide regulatory input to drug projects and products globally. This is achieved by developing and implementing regulatory strategies based on current legislation and regulations. We are responsible for compiling and maintaining regulatory files, including evaluation of the regulatory implications of changes and necessary actions in close collaboration with a wide range of stakeholders from e.g. Product supply, CMC, clinical RA areas, RA affiliates, QA and Marketing.
The job
As Head of RA CMC Semaglutide Injectables, you will lead the people and set direction to ensure that we as a team provide best in class RA strategies to the projects we support, thereby ensuring fast submissions and approvals globally. You will be part of submitting new drug applications and follow life cycle management projects and build strategies with the team, provide input and communicate regulatory requirements to stakeholders to ensure the best regulatory strategy.
Our organisation is dynamic and there is focus on optimising work processes both in relation to implementation of new regulations and in relation to thinking “out of the box” and setting bold regulatory strategies enabling us to go above and beyond to the benefit of the business and the patients. You will be involved in cross functional projects with our stakeholders and get a unique opportunity to establish a global network with our affiliates.
Qualifications
You hold a master’s degree in Science, Engineering, Pharmacy or other relevant education and have extensive experience from the pharmaceutical industry, preferably from Regulatory Affairs. You have demonstrated your ability to lead collaborative teams and have experience with setting directions and motivating people to be ambitious in their work and interaction with stakeholders.
As a person you have a proactive mindset – you take the lead on overcoming challenges and show your team the way forward. You demonstrate a sound business understanding when you develop regulatory strategies. You believe in empowering people around you, offering them constructive feedback and guidance to improve their performance. You are well-organised and have a good strategic focus. You are a skilled communicator and can cooperate at any organisational level.
At Novo Nordisk, your skills, dedication and ambition help us change lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development.
Contact
For further information please contact Sabine Tarp +45 3075 5404
Deadline
April 19th 2020
Millions rely on us
To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronical diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.
Information og data
Denne ledige stilling har jobtypen "Afdelingsleder", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 3.4.2020, 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.
- Afdelingsleder
- Søborg
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