Dynamic Global Regulatory Affairs CMC Director to enable innovation in manufacturing
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Søborg
- Regulatory
- Søborg
Are you passionate about developing innovative products, committed to obtain regulatory approvals and driven by setting and negotiating ambitious strategies? Are you a real team-player and is collaboration an ingrained part of your DNA? Do you have a proven track record of leading and developing highly engaged teams and do you have a global mindset? …then this leadership opportunity might be the right one for you!
About the area
Global Regulatory Affairs (GRA) is anchored in the R&D organisation under MARS (Medical Affairs, Regulatory Affairs, and Safety) and plays a vital part in our ambitious drug development programs and in maintaining and improving products on the market. You will head up the RA CMC Established Products department consisting of 12 highly skilled and dedicated employees with a unique combination of scientific and technical understanding, regulatory experience, commercial insight and patient focus.
You will become member of the RA CMC & Device leadership team and report to the Vice President of the area.
The job
As Regulatory CMC Director you will be accountable for global regulatory activities for our late stage marketed products, both within diabetes products as well as other therapy areas. You and your team will be directly responsibility for regulatory execution of manufacturing sites improvements and supply network strategies, - an execution that will be carried out in sync with our Regional RA hubs and the regulatory teams in Bangalore. In this work, it is key to provide stakeholders with risk-based scenarios for fast execution of submission plans and subsequent fast regulatory approvals. This will require bold approaches and keen negotiating skills. You will also use creativity and decisiveness in finding solutions when resources and time are limited. You will set priorities when global submissions cannot be made at the same time, make calculated risks when business benefits justify this, while ensuring the quality is not compromised.
Strong stakeholder management is essential, and you will be RA representative in production project governances at senior management level. You will be responsible for securing the strong performance of and ensure regulatory representation in relevant production project teams, contributing proactively to the project needs.
You will be in close dialog and conduct meetings with health authorities such as FDA, EMA, PMDA and engage externally with peers in industry. As a role model you will pave the way for strong collaboration with our GRA CMC departments in Bangalore as well as our regional and affiliate RA offices.
As a member of the area’s leadership team you will take active part in the transformational journey that the area is on. You will be encouraged to find new ways to create a culture of continuous learning that will enable us to build an organisation to meet our future needs. You will get the opportunity to inspire, empower and develop employees with a focus on optimising the way we work, setting ambitious goals and going above and beyond to the benefit of the business and the patients. Since this is a truly global job, it is critical that you can work with the multiplicity inherent of a global organisation.
Qualifications
We expect you to have a master’s degree in life sciences with a minimum of 8 years of relevant experience from production or regulatory affairs and 5 years of leadership experience. You have experience working with health authorities and working with production sites. You have extensive experience working with life cycle management and have preferably been involved in the phases of drug development leading up to product launch.
You take leadership naturally, set direction, and have high professional expectations for yourself and your colleagues. You have a strong people leadership track record and demonstrated your ability to inspire, empower and develop employees. You have an international mind-set, familiar with cross-organisation and global work and can navigate well in a project-driven matrix organisation where you demonstrate a sound business understanding.
Working at Novo Nordisk
At Novo Nordisk, we use our skills, dedication and ambition to help people with diabetes and other chronic diseases. We offer the chance to be part of a truly global work place, where passion and engagement are met with opportunities for professional and personal development.
Contact
For further information, please contact Jens Bjørn Nielsen +45 3075 6120.
Deadline
23. November 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 chronic 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 "Apoteker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 12.11.2020, 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.
- Apoteker
- Søborg
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