Director RA CMC Diabetes and Obesity
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Søborg
- Regulatory
- Søborg
We are seeking a Director to head up RA CMC Diabetes and Obesity. This is an exciting opportunity for an experienced leader to take on responsibility for regulatory CMC activities on our diabetes and obesity development projects.
You will be heading a broad scope of regulatory responsibility from early development to life cycle management, CTAs for different phases, MAAs global roll-out and variation applications.
The portfolio covered is oral semaglutide pipeline as well as 10-15 other projects in early development. Some of the major production facility investments are part of the scope as well.
The area and department
The department is part of the VP area RA CMC & Device, part of Global Regulatory Affairs. We are approximately 90 colleagues in the area which covers all regulatory aspects in regards CMC, devices and digital health. The area supports the business by obtaining fast regulatory approvals through strategic planning of submissions, utilisation of new regulatory pathways and by engaging with regulators. The area is continuously looking for innovative ways to meet regulator expectations while aiming to reduce the regulatory burden for the business.
You will head up the RA CMC Diabetes and Obesity team consisting of 12 direct reports (Specialists, professionals and associates). You will lead the organisation according to Novo Nordisk Way – our foundation that sets the direction for all employees.
You will be part of the RA CMC & Device management team of 8 Department Managers and Directors. As department head, you are also expected to contribute outside the immediate responsibilities of the position by seeking opportunities and providing support across the area, when priorities necessitates it.
Qualifications
You are an experienced leader who have demonstrated an ability to lead in a changing environment. You possess the capabilities to lead a team of highly scientific and experienced colleagues and to make decisions with high business impact. You have in-depth professional experience within the regulatory field and have had direct interactions with agencies and regulators and you bring experience from pharmaceutical manufacturing.
As an individual, you are robust and able to see the big picture. You provide clear direction and set priorities on busy days. You have a strategic mind-set, strong interpersonal skills and are known for building lasting relations with your stakeholders.
Key stakeholders include colleagues from R&D, manufacturing and manufacturing development, colleagues from our international offices and regulators.
The position is located in Søborg, Denmark. Global travel activity is to be expected.
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 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 at +45 3075 6120.
Deadline
9. February 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 "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 28.1.2020, 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.
- Øvrige
- Søborg
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