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- Develops and implementss global regulatory strategies for obesity projects from early development to worldwide submission and approvals of initial marketing authorisation applications
- Together with the RA Matrix team, provide the regulatory strategy to global project teams, facilitating gateway passages, contributing to protocols, clinical trial applications, pediatric planning, labeling, health authority interactions, and managing submissions of applications, variations, and amendments
- Supports due diligence and integration in business development opportunities with expertise within the obesity area
- A MSc and / or PhD in Life Science or any other related field
- Extensive knowledge of the drug development and life cycle management process from direct participation in project teams through substantial parts of the product development life cycle
- Solid clinical regulatory affairs experience from early development to worldwide submission and approvals of initial MAAs
- Proven track record of line management and matrix leadership. Experience operating in large multi-functional and multi-national environment. Ability to coach and develop high performing teams with an inclusive and collaborative leadership style
- A strong organisational leadership toolbox, including business planning, ability to navigate complex matrix environment, manage conflicting priorities and operate in a quickly changing environment
Senior Director, RA Obesity - Søborg, Danmark - Novo Nordisk
Beskrivelse
Senior Director, RA Obesity
Are you passionate about leadership and bringing the best out of people? Do you have a growth and innovative mindset to drive change in a future-ready environment? Do you enjoy building excellence within processes to render them effective and agile? Do you like working with a lot of engaged and competent colleagues? Do you also like having fun at work?
If yes, you may be the right fit to become our new Senior Director for the Regulatory Affairs Obesity department in Global Regulatory Affairs (GRA) in Søborg/Copenhagen.
Apply now for a life-changing career
The position
Reporting to Vice President, RA Diabetes & Obesity, you will be an active member of the RA Diabetes & Obesity leadership team.
You will lead an organisation of approximately 20 employees (Managers, Global Regulatory Leads and RA professionals). Coaching your direct reports, fostering talent development, and ensuring the development of your area is an important part of the role. You will enable knowledge sharing and drive collaboration across the teams and with stakeholders across the value chain including regional representatives.
You will be responsible for all regulatory activities for the obesity portfolio to ensure approval of clinical trials, marketing authorisation applications (MAA) and ultimately marketing authorisation licenses in an expedited manner and with the most competitive labels worldwide.
As part of that you will ensure RA Obesity:
Qualifications
To succeed in this role, you will have:
About the department
You will join the expanding department of RA Obesity situated in Søborg, Denmark. We work on development projects ranging from early research entailing candidate selection through to late-stage development and filing of Marketing Authorisation applications globally. We have a broad and expanding obesity portfolio; an indication that severely affect millions of people globally.
Our department consists of 2 teams each headed up by a RA manager and we are in total around 20 dedicated and highly engaged employees with diverse background and experience. We work in a flexible set-up where trust and openness, sparring, challenge, and knowledge sharing foster an inclusive and innovative culture we all enjoy being part of. The atmosphere is informal and good humor is always welcome.
Working at Novo Nordisk
At Novo Nordisk, we do not wait for change. We drive it. We are 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 further information, please contact the Vice President, RA Obesity & Diabetes, Betina Østergaard Eriksen
Deadline
18 August 2024.
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.