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stillingsbetegnelse:
Senior Regulatory Professional for CMC & Device Semaglutide Injectables

jobbeskrivelse:

Join a fast-changing environment where engaged people do their best every day to obtain and maintain clinical trial applications and market authorisations worldwide for all Novo Nordisk medicinal products across the globe. The employees in Regulatory Affairs (RA) have a unique combination of scientific insight and the ability to navigate many agendas and stakeholders simultaneously. This makes RA a truly interesting place to work but also quite challenging. Are you up for this challenge?

 

About the department

The department RA CMC & Device Semaglutide Injectables is part of RA CMC & Device in Regulatory Affairs and is situated in the Novo Nordisk project house in Søborg together with other regulatory affairs functions. We are a group of 9 highly skilled and dedicated people involved in every CMC aspect concerning our marketed products and development projects. The project portfolio is evolving and to be able to handle the challenges and opportunities within our area of responsibility that this brings we are looking for a new colleague to the department. 

You will work with experienced and engaged colleagues and work closely with many different stakeholders within Novo Nordisk headquarters and affiliates. In this dynamic environment, our dedicated group prepares global regulatory strategies for the CMC part of clinical trial applications, marketing authorisation applications and post approval CMC variations. Furthermore, the department is responsible for interactions with regulatory authorities globally.

 

The position

As Senior Regulatory professional is responsible for providing strategic input in developing global Regulatory CMC strategies, provide support and execution of regulatory submissions for development projects and products throughout life cycle management. You will be responsible for planning, coordinating and reviewing regulatory documentation e.g. supporting preparation of applicable sections of submission packages, responses to agency questions for global markets and Agency Meeting Packages. It is expected that you are proactive, challenge the discussions and contribute to project team decisions for the product you work with. 

The Senior Regulatory professional are expected to develop CMC regulatory strategies demonstrating sound regulatory insight, ensuring a balanced approach to regulatory risk, understanding the impact to the business and utilise regulatory intelligence and incorporating knowledge of the changing regulatory environment. You will be expected to actively represent Novo Nordisk externally and communicate within field of expertise.

 

Qualifications

Your background covers a Master of Science e.g. in Pharmaceutical science or a similar university degree with min 5 years relevant experience from the pharmaceutical industry including some years of regulatory CMC experience either from the pharmaceutical industry or from a medical agency. You have strong technical skills, as well as a thorough understanding of related pharmaceutical operations (e.g. manufacturing, process development, analytical, and quality assurance). 

You are able to communicate scientifically difficult topics related to protein chemistry/analytical chemistry/manufacturing of drug products, so it is easy to understand for health authorities and you find this process very interesting. 

On a personal level you are curious to learn, organised and a proactive problem solver. You enjoy working in a team and in a project-oriented organisation. You are good at communicating and are completely comfortable speaking and writing in English and preferably also in Danish. 

In addition, you thrive in an environment with changing circumstances and bring a can-do attitude and a healthy sense of humour. You keep focus on jointly moving the projects, can work independently and bring an innovation mindset seeking novel solutions to the challenges we face.

 

Working at Novo Nordisk

At Novo Nordisk, your skills, commitment and ambition help us change lives for the better. In exchange, we offer you a chance to work with extraordinary talent and to develop professionally and personally.

 

Contact

For further information, please contact Department Manager Sabine Tarp at +45 3075 5404.

 

Deadline

15 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.

numberOfPosts: 1

jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C3213

abstractJV_contact_0: Please apply using one of the specified channels

positionTypeCode: directhire

contractTypeCodes_0: fulltime

Arbejdsgiver Navn: Novo Nordisk A/S

source: DK-STAR