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stillingsbetegnelse: Regulatory Professional in Regulatory Operations

jobbeskrivelse:

To support our world-wide regulatory submissions as well as our change handling process, we are seeking a Regulatory Professional to join the RIMS Management Department.

 

About the department

RIMS Management 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 7 highly motivated and engaged employees who are responsible for the Regulatory Information Management System (RIMS) supporting our global product submission, approval and post approval processes.

 

The position

Your main responsibility as a Regulatory Professional is to coordinate the activities around the RIM system and processes and provide expert process guidance to relevant stakeholders across the global Novo Nordisk organisation. The RIM system contains information about all marketed products and devices at Novo Nordisk and in close collaboration with stakeholders from the Regulatory Products Groups and Therapeutic Areas you will ensure that data is correct, up to date and available in the system at all times.   

The RIM system and process support order generation, batch allocation and correct batch releases. Therefore, you will also be central point of contact for many stakeholders outside Regulatory Affairs such as Product Supply, Quality and Logistics globally, whom you will be collaborating with to support that the right product variants reach the market and thereby the patients. 

We are currently very focused on optimising and simplifying the full change handling process, and therefore you will also drive optimisation activities and participate in major process transformation projects. Together with stakeholders, you will therefore work on identifying simple solutions that both comply with (new) regulatory requirements and ensure best in class processes.

 

Qualifications

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

We expect that you can drive activities and tasks independently and systematically and that you enjoy working in a dynamic environment. You have a quality mind-set, you can 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 Pil Arnild Mortensen at +45 3079 0635.

 

Deadline

11. juni 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/C2423

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