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Regulatory Project Manager

Category:  Regulatory
Location: 

Gatwick, West Sussex, GB

   

Are you a Regulatory professional looking to make a career move and would like the opportunity to work for a progressive, expanding Regulatory team in one of our newly created positions as a result of Brexit implications and our exciting therapy area pipeline?

 

Do you have experience of managing, planning and executing Regulatory Projects, either within an affiliate, or global/regional capacity? Then we have permanent and contract opportunities for you right now! 

 

Novo Nordisk is a global healthcare company with almost 100 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people living with obesity, haemophilia, growth disorders and endocrine disorders.

 

Headquartered in Denmark, Novo Nordisk employs approximately 44,000 people in 80 countries and markets its products in more than 170 countries. 
  
The Job
The permanent position is based at our head office in Gatwick and will require on site presence c3 days per week. If you are a contractor we can offer more flexibility on remote working in the short term - we are looking for interim support whilst we recruit for our new permanent team member,

 

In this job you will manage, plan and execute Regulatory projects, including planning resources, budget, strategic input and review, risk analysis and implementation strategy.

Tracking closely to anticipate and address project issues you will work closely with all internal stakeholders across the Regulatory team, the UK affiliate, global and regional colleagues in the business, together with external stakeholders such as the MHRA, ABPI.

 

You will be responsible for proactively mapping the business needs versus planned changes to regulatory files and legislation, ensuring timely, competitive and strategically enhancing submissions and approvals for the MHRA; with a focus on new innovative products and life cycle changes.

 

There will be close collaboration with both internal and external stakeholders including our global regulatory portfolio team; representing the UK Regulatory (UKRA) as Project/Therapy lead and member for innovative pipeline initiatives and you will also be required to represent Novo Nordisk Regulatory at external industry meetings and provide internal training to the business.

 

Qualifications
You should be a Science graduate (or equivalent) with a proven successful track record within the pharmaceutical industry relating to managing projects within the regulatory environment.

 

Essentially you will demonstrate full knowledge of regulatory legislation and processes (national and EU) and the ability to understand and decipher new legislation to assess business impact.

 

Previous experience of compiling, submitting, and gaining approval for Marketing Authorisation Applications (MAA) is essential. In addition, your experience will have been gained within biologics as opposed to only generics.

 

The successful candidate for this opportunity will be a highly organised, proactive, extremely adaptable individual who can work independently but is also an enthusiastic team player who can contribute to effective team performance with excellent communication and influencing skills and the ability to build relationships at all levels. 

 

The ability to lead complex operational and strategic projects is essential, with clear evidence of successful cross functional working and problem solving. A high level of concern for quality and detail is necessary along with good IT skills. 

 

About the team
The Regulatory, Safety & Medical Information department is part of the Clinical, Medical & Regulatory business unit within the UK Affiliate. In this position you will be part of an expanding Regulatory team, reporting to the Head of Regulatory, Safety & Medical Information.

 

The Regulatory Affairs Officer will work with the team to support lifecycle management and clinical development activities ensuring regulatory requirements are adhered to and excellent working relationships are maintained both internally and externally.  


The regulatory activities will enable the implementation of Department and Company business objectives to support the overall Novo Nordisk strategy.


What we offer?
We offer a competitive salary plus bonus, private healthcare, life assurance, income protection and a fantastic pension scheme. You will also be entitled to flexible benefits which include holiday insurance, childcare vouchers, optical insurance, holiday buy and sell, Perkbox and much more! Working at the head office at Gatwick you also have access to even more amazing benefits such as free parking, free breakfast and lunch, lunch time fitness classes, access to our gym and workplace massages!

 

Novo Nordisk offers an excellent inclusive culture with a focus on healthy living, flexible working and corporate social responsibility activities. The Novo Nordisk Way includes our vision, our values and our commitment to ensure we are a great place to work and we want you to be a part of that!

 
Contact
We cannot accept CV’s via email so if you wish to apply please do so via the Novo Nordisk website. For an informal discussion in the first instance please contact the hiring manager Nicola Visage, NCVS@novonordisk.com

 

Deadline
4th December 2021

 

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.