id: NTAyMjM5NCA3

reference: 5022394

documentId: 5022394

connectionPointId: 7

lastModificationDate: 1564057826530

stillingsbetegnelse:
Senior Regulatory Professional with strong collaboration skills for Established Products

jobbeskrivelse:

Novo Nordisk Regulatory Affairs makes medicine available to patients all over the world by ensuring rapid regulatory approval in all of our markets. Regulatory Affairs is a fast-changing field, and the dedicated employees in our unit need both keen negotiating skills and scientific insight to serve as Novo Nordisk’s advocates around the world – and make a meaningful difference to our business.

 

About the department

The RA CMC Established department is situated in the Novo Nordisk project house together with other regulatory affairs functions in Søborg. We are a group of 14 highly skilled product leads, project managers and RA CMC specialist responsible for the handling regulatory strategies of business critical and complex projects for established products within our Diabetes and Biopharm portfolio. 

We have a close collaboration with our RA CMC colleagues in Bangalore India who is responsible for the daily task of LCM support to stakeholders within Novo Nordisk global manufacturing sites, our affiliated offices and health authorities around the world. 

Our primary stakeholders are Product & Process Development, the global manufacturing sites together with Novo Nordisk Supply Chain planning. We are engaged in high potential projects in order to support the demand of increasing capacity and flexibility in our global manufacturing network and implement newest technology.

 

The job

As a regulatory professional, you are responsible for supporting cross functional projects and support our RA CMC colleagues in Bangalore. You will support our primary stakeholders with regulatory pre-assessment and contribute with regulatory input and strategies to the potential project plan. The job involves a high degree of planning, coordinating and submitting variation applications. 

The job requires some travel activities to Bangalore, but also that you continue your individual development and that you keep being updated within relevant regulatory and biotech disciplines.

You will work in a fast-paced environment with tight deadlines, cross-departmental collaboration and deal with the challenge of international communication. The atmosphere is informal and good humour is always welcome.

 

Qualifications

You have a university degree in science and documented professional experience from a regulatory affairs position and/or the pharma industry.

You are organised, a good planner and exhibit driver. You show a winning attitude and keep your spirits high even when under pressure. You are a strong team player and can also work independently. You are fluent in speaking and writing in English.

 

Contact

For further information, please call Manager Jacob Larsen +45 3079 1441.

 

Deadline

8 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/C2421

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