Manager - Regulatory Affairs Haemostasis New Products

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 250 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.

Heading up the Haemostasis New Products department, you will report to the Vice President, be part of the RA Haemostasis Management Team and manage a staff of seven persons. You will have a key leadership role for development of new projects within the Haemostasis portfolio - one of Novo Nordisk’ strategic priorities. Our main focus is on haemophilia and other coagulation disorders.


Challenges
Your key areas of responsibility include global regulatory plans, input to strategic documents, submissions and approval of INDs, CTAs, PIPs and MAAs worldwide in cooperation with global project teams. Your key focus will be to ensure regulatory learning across projects, and to be updated on current and emerging legislation. Line management responsibilities include resource management, target setting, budget preparation and people development.


Qualifications
The ideal candidate holds a relevant academic degree with at least five+ years of regulatory experience with a proven record of liaising with regulatory authorities, preferably both FDA and EMEA. Experience with early and late development projects, broad disciplines (clinical, non-clinical, CMC/quality) and good business understanding will be an asset. Further, strong people management skills including experience in leading highly specialised academics, and fluency in both spoken and written English are required.


We can offer an exciting job in a culture built on collaboration between people, departments, functions and the surrounding society with an opportunity to acquire further knowledge through supplementary training and participation in our management development programmes.


Contact
For further information, please contact Elisabeth Erhardtsen at +45 3079 1620.

Denmark - Gladsaxe
Date posted: 16 Jun 2009
Deadline: 21 Jun 2009

Please forward your application online
Please mark your application "NN45846 Manager".

Apply now:
http://www.novonordisk.com/jobs/job_section/jobdetails.asp?

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