Director for Regulatory Process & Process Owner Delegate (POD)

Are you a natural leader who is passionate a bout developing people and teams? Are you ready to play a leading role in driving 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 Global Regulatory Affairs (GRA) and RA CMC & Device.

The Position

As Head of Regulatory Process, you will lead a small team of highly specialised Novo Nordisk (NN) Process Managers (PMs) and act as POD for the “Submission & Registration” and “Labelling” processes on behalf of the CVP in GRA. Striving for process excellence, you will drive innovation and change in a highly regulated global environment to leverage process simplification and digital transformation opportunities across the portfolio and SVP/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 include:

- Setting direction and strategy for the team and inspire a learning culture.

- Ensuring continued employee and team development and aligning team competencies with company values and ambitions.

- Defining and executing the process strategy and direction in alignment with the Process Owner (PO) and leadership across RA and RQ&C.

- Ensuring your process and sub-processes are stable and simple for the users to operate, compliant with external requirements, and continuously improved.

- Introducing new ways of working and tools that have a profound impact on how your process performs across the NN value chain.

Your qualifications:

- Master's Degree in life science, business or similar.

- Strong interest in developing people and teams with a proven track record of building high performing teams and demonstrating enterprise leadership mind-set.

- Exceptional communication skills and recognised as a leader who exceeds in driving change and innovation.

- A proven track record of setting up, driving, and continuously optimizing highly regulated cross-functional processes in a large, complex, and global organisation utilizing digital tools.

- Demonstrated experience solving unique and complex challenges and delivering business results with global impact.

- Willingness and courage to ‘constructively dissent’ and challenge senior management opinions on key issues.

- Ability to reduce complexity despite regulatory environments and adjust quickly to new situations in a continuously developing environment.

- Open-minded to new ways of working and implementing alternative solutions ensuring the right level of compliance.

As a person 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.