Head of Global Regulatory Affairs - Biopharm, VP level position

Novo Nordisk A/S





Søborg, Capital Region of Denmark, DK

Expanding our biopharmaceutical business is a key strategic initiative at Novo Nordisk - do you want to be part of driving it? In this unique opportunity, you will lead the Global Regulatory Affairs Biopharm organisation and deliver best in class regulatory strategies and support the organisation to optimise our assets within the biopharmaceutical portfolio.

About the department
The department is part of Global Regulatory Affairs (GRA). GRA is accountable for regulatory licenses for current and future products responsive to the worldwide business needs of Novo Nordisk. GRA is a headquarter function located in Copenhagen (Denmark) and Bangalore (India) and we work in close collaboration with regulatory colleagues in the affiliates. The GRA Biopharm team is based in Copenhagen (Denmark).

The position
You will head up the biopharmaceutical business within GRA with direct report to the Corporate Vice President of GRA and you will be responsible for driving the development and execution of the global RA strategies. For our biopharmaceutical business products within haemophilia, growth hormone disorders and hormone replacement therapy, you will be accountable for maintaining and updating marketing authorisations with focus on maximising pipeline value including negotiating with authorities to obtain approvals. As part of heading up the GRA Biopharm organisation, you set direction, supervise and develop Global Regulatory Leads and teams with first class RA competencies and ensure that high regulatory science standards are observed throughout the assigned portfolio.

You will be member of the GRA management team but will also join our biopharmaceutical senior leadership team headed up by the Executive Vice President of Biopharm. In addition, you will be involved in due diligence acting as RA anchor for Biopharm assets and become member of ad-hoc groups responsible for driving product development and commercialisation with therapeutic areas of responsibility, including agency/GCP inspections, FDA Advisory Committee preparation etc.

You have significant experience within Regulatory Affairs with plus 15 years’ experience from pharma industry, hold a Master of Science degree and you already have a proven track record of developing and executing RA strategies for biopharmaceutical products in development and on the market.

You have a strong interest in developing people and teams with a proven track record of driving change. You have great communication skills and you are known as a leader that exceeds in driving change and innovation. As a person you are ambitious and strive to become a future leader on the next level after this position.

You either hold a global strategic RA position in a big pharmaceutical company, is head of RA in a biotech company with leadership experience from a big pharmaceutical company or hold a senior position at a regulatory agency with pharma experience. You have experience in managing key stakeholders like senior R&D management, production, commercial, affiliates and executive management.

Since this is a global position it is important that you are fluent in written and spoken English. As head of GRA Biopharm travel activity can be expected with around 50 days per year.

For further information please contact Jacob Dahl Nielsen at +45 3075 5486.

4 August 2019.

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.

Ansøgningsfrist d. 04.08.2019

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Novo Nordisk A/S - hurtigt overblik

Novo Nordisk A/S
Novo Nordisk A/S
Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders and obesity.

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