Regulatory Specialist

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Job description

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 supporting product lifecycle management at all stages through to the generation of commercially valuable product licences? Then this could be the opportunity for you!

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*

This position is based from our head office in Gatwick, with flexibility to work part of the week from home.

You will be a strategic business partner by supporting the UK affiliate in all aspects of regulatory affairs, providing accurate and relevant internal advice together with being the point of contact to the local health authority for allocated product or project responsibility.

In addition, you will be responsible for ensuring submissions and approvals for the Medicines Healthcare products Regulatory Agent (MHRA) for all national licences and maintaining our product licences, including labelling coordination for both national and centralised licences in the UK.

There will be close collaboration with both internal and external stakeholders including our global regulatory portfolio team, publishing, global labelling, local marketing and market access and you will also be required to represent Novo Nordisk Regulatory at external industry meetings and provide internal training to the business.

Additionally, as part of the role you will be required to lead or participate in projects, such as new product launches, as identified by the Head of Regulatory, Safety & Medical Information.

*Qualifications*

You should be a Science graduate (or equivalent) with a proven successful track record within the pharmaceutical industry and regulatory environment; including 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 innovative biologics as opposed to only generics.

The successful candidate for this opportunity will be a 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.

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*

Please submit your application via the Novo Nordisk website. We are unable to accept direct CVs.

*Deadline*

19th November 2021