Regulatory Policy Professional

2 weeks ago


Søborg, Denmark Novo Nordisk AS Full time

Join a fast-changing environment where people do their best to get Novo Nordisk products approved across the globe. In Global Regulatory Affairs, o ur people have a unique combination of scientific insight and ability to navigate many external requirements and stakeholders.

Are you our new colleague?

About the Department


You will be part of Global Regulatory Affairs Policy & Intelligence . RP&I ensures compliance with regulatory requirements and influences external regulatory frameworks . We combine scientific insights with the ability to navigate external agendas and stakeholders. Together with the Novo Nordisk Global Regulatory Affairs organisation and our network of RA colleagues in Novo Nordisk affiliates, we monitor new and developing regulations and identify and assess emerging regulatory trends and issues. On that basis, we support Novo Nordisk’s product development and life cycle management strategies, promoting overall regulatory excellence both internally and externally. We support the company’s activities in a number of prioritised industry associations and other external fora where future requirements or implementation of current requirements are being discussed with regulators. We are a hybrid team with members based in Søborg - Denmark, Istanbul - Turkey, Bangalore - India, Tianjin - China, and Washington DC - US.

The Position


You will be expected to make an impact by striving for improvement of the external regulatory frameworks that regulate our business. The job is a unique opportunity to demonstrate your capacity for analysing, responding to, and influencing new regulatory requirements. As an RA Policy Professional, you will conduct impact assessments around new and draft requirements that impact Novo Nordisk regulatory procedures, and you will drive the development of Novo Nordisk responses to these when relevant.

You will support the planning and execution of strategic advocacy initiatives around prioritised themes including working with Novo Nordisk representatives in external for a and participating in external working groups yourself. The work will take place in collaboration with colleagues in RP&I and the rest of the Regulatory Affairs through frequent sparring.

You will report to the Head of RA Policy & Intelligence and be based in Søborg, Denmark.

Qualifications


You have an academic degree in Pharmacy or similar and have 3-5 years relevant job experience working in Regulatory Affairs e.g. as part of an RA product development team. The role requires knowledge of regulatory requirements and practices primarily in the European Union, while other markets will be a plus.


You have a strategic mind-set and great stakeholder management skills. You are independent, result-oriented, and like to be challenged. You will be expected to have the ability to present complex issues in a clear manner. Excellent communication and presentation skills are required. You must be fluent in written and spoken English.
 



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