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Global Regulatory Lead for clinical-stage project within new therapeutic area

Category:  Regulatory
Location: 

Søborg, Capital Region of Denmark, DK

   

Join Regulatory Affairs (RA) and become part of an exciting environment where engaged people are committed gaining approval of Novo Nordisk’s medicines by regulatory authorities across the globe. Our people have a unique combination of scientific insight, patient focus, and the ability to navigate many agendas and stakeholders. That makes Regulatory Affairs a truly interesting and challenging place to work.

 

About the department

RA GLP1-1 Diabetes & NASH Projects department is responsible early Life Cycle Management and development projects within Type 2 Diabetes and NASH. We work as an integrated part of the global development and research project teams and cross-functional sub-teams. We are eleven dedicated and highly engaged employees reporting to the Director of RA GLP-1 Diabetes and NASH Projects. 
 

Within Type 2DM, we are working on bringing our treatments to a higher level of innovation to serve the patients. We are focusing on innovative regulatory strategies to allow approval of our drugs for additional benefits helping patients with Type 2DM to manage their disease and its complication and comorbidities. 
 

Within NASH, we work on bringing safe and effective treatments to the patients with currently no approved treatment options. We are focusing on regulatory strategies to accelerate approval and access to the treatments. We support development of internal Novo Nordisk assets and partnership initiatives. We engage in a dialogue with experts and health authorities to extend understanding of the disease and its diagnosis.  

 

The job

We are looking for Global Regulatory Lead for a clinical stage NASH project. This is a strategic position that requires leadership skills, scientific background, and regulatory/ drug development proficiency. As a Global Regulatory Lead/Principal Regulatory Specialist you will become a member of the Global Project Team (GPT) and will be expected to provide the project with ambitious regulatory strategy and tactics but also to influence the overall project strategy. You will be expected to interact with Novo Nordisk senior management, stakeholders within multiple functional areas and be involved in discussions on all aspects of drug development.

 

You will lead matrix regulatory teams to ensure global strategic outlook, timely conduct of Health Authority interactions worldwide, submissions and approvals of regulatory files resulting in best possible approved label.  

 

All in all, you will have a large responsibility and a lot of influence and impact on the way we reach our goals. In this senior role you will also be asked to mentor junior colleagues within the department as well as actively share your knowledge and experience.

 

Qualifications

We expect you to have a university degree in life science preferably complemented by a PhD and have 6-8 years of regulatory and drug development experience. From your career you have solid experience with regulatory strategies and direct interactions with regulatory authorities on an international scale. You have proven strong negotiation skills and a sound business understanding. You also know how to set direction, lead and motivate your team to work for joint objectives. At the same time, you are the team player who assists and mentors your colleagues.

 

As a person you are well organised and have solid problem-solving capabilities, you show a winning attitude and never loose your strategic focus. You can keep your spirits high even when under pressure. You are a skilled communicator who can cooperate at any organisational level. Finally, you are comfortable using your fluent written and spoken English on a daily basis.

 

Working at Novo Nordisk

At Novo Nordisk, we use our skills, dedication and ambition to help people with diabetes. 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.

 

Contact

For further information, please contact Magdalena Jayatissa + 45 30 79 49 42

 

Deadline

31 January 2021

 

To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. 

We commit to an inclusive recruitment process and equality of opportunity for all job applicants.

 

 

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.