Vice President for Regulatory Affairs Device

Location:

Søborg – Denmark

Salary:

Competitive

Type:

Permanent

Main Industry:

Search Finance, Banking & Insurance Jobs

Other Industries & Skills: 

Legal

Job ID:

131367322

Posted On: 

28 November 2024

Are you deeply passionate about leadership and Regulatory Affairs (RA) in medical device solutions on a global scale? Do you possess the experience and vision needed to guide a top professional team in a multinational environment? This is your chance to harness your ambition, passion, and expertise to drive strategic direction across the value chain within a complex global stakeholder landscape as our new Vice President Regulatory Affairs Device.

The position
As our business and product portfolio continues to expand and diversify, there is an increasing need to drive the strategic agenda for all regulatory medical device activities within the Novo Nordisk development pipeline and recently marketed products. A newly established position as Vice President for Regulatory Affairs Device is open for an experienced, purpose driven and business minded leader with solid understanding of Medical Device regulations.

In this role, you will:

-Spearhead the strategy for RA Device globally in Novo Nordisk.
-Be accountable for the development and execution of regulatory strategies for medical devices and device constituents of the Novo Nordisk combination products in the development pipeline as well as the life cycle management of already approved drugs.
-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.
-Build and maintain strong relationships with key stakeholders and influence across levels, valuing diverse perspectives.
-Connect with peers in the industry and ensure engagement with relevant industry/pharma associations while keeping up with changing regulatory requirements.
 
In this position you will have an opportunity to influence the future way of working in the Novo Nordisk Regulatory CMC and Device function. You will be part of the Leadership Team of RA CMC & Device and the location of the job will be in Søborg, close to Copenhagen, Denmark. You will be working in a multicultural and global setting and must expect about 10-20 travelling day´s per year. You will report to the Corporate Vice President (CVP) for RA CMC & Device. 

 
Qualifications
To thrive and succeed in this role, we expect you to have:

-A Master of Science degree in natural sciences such as engineering, pharmacy, chemistry or similar. 
-15+ years of experience from the pharmaceutical industry, working in a global regulatory function, manufacturing or a function collaborating closely with regulatory affairs. 
-10+ years of robust leadership cultivated within a diverse, international setting and a seasoned leader of leaders with ability to lead and create followership both directly and in a matrix organization. 
-Experience interacting with key stakeholders at senior leadership level in production, production development, R&D, commercial and affiliates globally.
 

Overall, this position is right for you if you have a strong interest in developing people and teams and you are known as a leader that excels in driving change and innovation. You inspire your surroundings to exceed their best, and you will never compromise on the quality of the work you do. You bring an enterprise mindset, business acumen as well as analytical skillset. You set direction in business-critical processes and navigate in an environment where decisions are often quick and ever changing. You act with impact, have strong negotiating skills and are clear in your communication and comfortable engaging with senior management level. You possess strong personal drive and exhibit high level of integrity.

About the area
The area is one of four areas in the RA CMC & Device organisation and as head of the area you will lead more than 50 colleagues with a wide range of expertise and experience, organized in three departments. The area is responsible for all regulatory medical device activities within the Novo Nordisk development pipeline and recently marketed products.
 
RA CMC & Device has an increasingly important function in Novo Nordisk due to the corporate ambition of bringing new products and innovation progressively faster to market by shortening development timelines and optimize and expand production capacities.
 
The function is represented across the value chain in governance and project teams and act as important business partners by soliciting tough decisions based on regulatory requirements, business needs and patient safety.

RA CMC & Device is accountable for all regulatory activities related to CMC and medical devices for both development projects and marketed products. We are a global function of more 270 colleagues located primarily in Søborg, Denmark and Bangalore, India, as well as colleagues in US, UK and France. We strive to be the best in the industry, delivering safe and innovative products to patients by strategic business partnering, proactive collaboration with health authorities and efficient operations. 

Working at Novo Nordisk
Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 69,000 employees around the world. We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we’re working toward something bigger than ourselves, and it’s a collective effort. Join us! Together, we go further. Together, we’re life changing.

Contact
For further information, Jens Bjørn Nielsen, Corporate Vice President RA CMC & Device, at +45-30756120.
 
Deadline
9 December 2024.

You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV.

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.

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