Director for Regulatory Process
4 weeks ago
Do you have a process mindset and enjoy and have a proven record of working across a +1000 people organisation streamlining, managing, and improving processes? Are you ready to play a leading role in driving change and innovation of the regulatory processes for approval of new drugs, devices, and digital solutions, and expand availability of existing products?
If yes, we encourage you to apply for this new exiting position as Director for Regulatory Process & POD representing the Global Regulatory Organisation.
The position
As Director for Regulatory Process & POD, you will lead a small team of highly specialised Process Managers and act as POD for the “Submission & Registration” and “Labelling” processes on behalf of the appointed process owner (Corporate Vice President, CVP of GRA). Striving for process excellence, you will, together with the regulatory Process Managers, drive high-level innovation and change in a highly regulated global environment to leverage process simplification and digital transformation opportunities across the portfolio and Senior Vice President (SVP)/ Executive Vice President (EVP) areas.
You will be setting and fulfilling the global process strategy, delivering global process improvements, mitigating risks, and driving change together with stakeholders across the NN value chain from early development until product discontinuation. This is a unique opportunity to implement regulatory strategies and priorities to ensure that the aspired process mindset is embedded in behaviours and practices globally.
Your main responsibilities will be focused on:
Qualifications
To be a competitive candidate, you should have: A master’s degree in life science, business, or any other related field
As a person you are open-minded to new ways of working and you are curious and visionary with a holistic and pragmatic approach acknowledging that details may be important to reach a solid solution. You can balance and change from a detailed to a broader helicopter-like perspective. Team-oriented, with a high degree of flexibility and cross-cultural awareness. You find it natural to listen, lead, and create followship, and you do that in an assertive and diplomatic way that builds trust in your team and with your stakeholders across levels.
About the department
You will head up a team of two highly experienced NN Process Managers and have a direct reporting line to the VP in RA Submission & Compliance. In Regulatory Affairs we manage submission, registration and labelling to obtain authority approval for all NN products and thus work across the value chain from early development until product discontinuation. We prepare and execute regulatory strategies, ensure approval of new drugs, devices, and digital solutions, and expand availability of existing products by label expansions and by ensuring approval of Novo Nordisk manufacturing network. We develop and do life cycle management of labelling text, instruction for use, colour and graphics and output final artwork for printed packaging material for the whole marketed portfolio.
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