id: NDkzNzg0MyA3

reference: 4937843

documentId: 4937843

connectionPointId: 7

lastModificationDate: 1548846487600

stillingsbetegnelse:
Senior Regulatory Professional in Regulatory Operations

jobbeskrivelse:

To support our world-wide regulatory submissions, we are seeking a Senior Regulatory Professional to join the Regulatory Affiliate Support department.

 

About the department

Regulatory Affiliate Support is part of the Submission Management area in Regulatory Operations, located in Søborg, Denmark. We work closely with stakeholders across the organisation both within headquarters in Denmark and India as well as affiliates worldwide. We are a team of 8 highly motivated and engaged employees who are responsible for the additional regulatory documents process supporting global submissions.

 

The position

Your main responsibility as a Senior Regulatory Professional is to be central point of contact for affiliates and provide them with additional registration file documentation such as export certificates and statements as well as product samples for submissions to health authorities worldwide. You will be interacting with many stakeholders in the company and with health authorities in order to provide responses and documentation to support the submissions.

 

You will be planning, coordinating and prioritising incoming requests as well as assessing regulatory requirements and finding solution to these.

 

In addition, you will be responsible for running optimisation activities and projects related to the additional regulatory documents process. You will thereby together with stakeholders identify solutions to new regulatory requirements as well as continuously optimise our process.

 

Qualifications

You hold a Master’s Degree in e.g. business/science/pharmacy/medicine combined with a strong business and process orientation. You have experience from the pharmaceutical industry and preferably within regulatory affairs.

 

We expect that you are able to drive activities and tasks independently and systematically and that you enjoy working in a dynamic environment. You are able to stay on target, work with tight deadlines and manage multiple assignments at the same time without losing track. You have very good analytical skills and problem solving abilities and address your responsibilities with decisiveness and a positive mind set.

 

You have advanced communication skills as well as experience with presenting in large forums as stakeholder management and communication are essential for succeeding in the job. Furthermore, we expect that you possess strong cross-cultural skills and are used to working with international business partners. Finally, full professional proficiency in oral and written English is a must.

 

In Novo Nordisk A/S it is your skills, your commitment and your ambitions which help us to improve many people’s lives. In return we offer you the opportunity to work with talented colleagues, and we offer you a wide range of opportunities for professional and personal development.

 

Contact

For further information, please contact Tina Lindquist at +45 3075 9652.

 

Deadline 10. February 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/C2631

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