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Regulatory Teamleader and Site Partner (Søborg, Denmark)

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Regulatory Teamleader and Site Partner

- Regulatory Affairs
- Denmark - Søborg

Novo Nordisk Regulatory Affairs makes medicine available to patients all over the world by ensuring rapid regulatory approval in all 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 department consists of 28 colleagues and covers both products under development and marketed products in the area of insulin and oral proteins. The department is responsible for maintaining the CMC part of the regulatory files and licenses as well as providing regulatory input during the various phases of drug development.

We work very closely with stakeholders within Novo Nordisk headquarters, manufacturing sites outside Denmark, our affiliated offices and health authorities. The department is organised in two teams. We are currently looking for a Team Leader/Site Partner for the RA Site and Quality Support team. The team consists of 6 colleagues.

The job
In the team you will lead and coordinate activities related to our manufacturing authorisations and ensure maintenance of documentation required for operation of our manufacturing facilities. The responsibilities cover biopharm as well as insulin manufacturing sites, hence the function of the team is shared across the six project/product areas in regulatory affairs.

The team maintains and updates our manufacturing authorisations, Site Master Files and other facility related documentation. In addition, the team has a coordinating role in ensuring regulatory input on proposed manufacturing changes and you will be representing RA in a cross-functional group responsible for approving major changes in production areas as part of Novo Nordisk quality system.

As Site Partner, you will serve as the primary liaisons between the manufacturing sites and regulatory affairs when establishing and carrying out the plans and strategies required for obtaining and maintaining relevant manufacturing authorisations and GMP licenses. You will also be working closely with the company’s inspection office, including in relation to planned health authority inspections.

As a Team Leader you will be responsible for team development, goal setting and prioritisation of tasks. You will report to the Director of the department, be an active member of the department’s management team and contribute to the departments’ strategic direction.

You will work in a fast-paced environment with tight deadlines, cross-departmental collaboration and deal with the challenge of international communication. You will be expected to make an impact and to ask questions and challenge the status quo if needed.

Qualifications
We expect you to have a university degree in science and experience within pharmaceutical production and/or quality assurance. Regulatory affairs experience is an advantage.

You have a proven record of strong people management skills and a sound business understanding. You set direction, lead and motivate your team to work for joint objectives. At the same time, you are the team player who assists your colleagues.

As a person you are well organised and have solid problem-solving capabilities. You show a winning attitude and never lose strategic focus. You can keep your spirits high even when under pressure, and as a skilled communicator you can cooperate at any organisational level.

At Novo Nordisk, we strive for excellence. As a world leader in diabetes care and a major player in haemostasis management, growth hormone therapy and hormone replacement therapy, we offer our employees opportunities for continuous growth.

Contact
For further information, please call Jens Bjørn Nielsen on +45 3075 6120.

Deadline
7 June 2013.

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