Regulatory Affairs Planning Expert

1 day ago


Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time
Strategic Regulatory Planning Role
We are seeking an experienced Strategic Regulatory Planning Specialist to join our Regulatory Affairs (RA) CMC & Device team in Denmark. This pivotal role is instrumental in driving governance for the prioritization of regulatory plans, ensuring strategic long-term planning, partnering with stakeholders, and driving improvement initiatives.

Main Responsibilities:
- Driving governance setup for prioritizing RA activities across affiliates and Product Supply.
- Ensuring strategic long-term planning for life cycle management variations to optimize supply chain efficiency.
- Leading RA Planning improvement initiatives and maintaining a comprehensive overview of all planning activities.
- Acting as a project manager to create simulations and scenarios for long-term planning of LCM projects in RA.
- Ensuring information flow and alignment across projects and therapeutic areas.

Key Qualifications:
- Master's degree in life sciences or a PhD required.
- Minimum 5 years of experience in regulatory planning, global regulatory requirements, or supply planning.
- Expertise in handling RA variations in life cycle management of pharmaceutical products.
- Strong communication skills with ability to present complex data to senior stakeholders.
- Fluency in English, both spoken and written.

About the Role:
This role drives governance setup for the prioritization of LCM activities, ensures strategic long-term planning, and manages improvement initiatives within RA Planning. The successful candidate will demonstrate subject matter expertise and act as a mentor to colleagues.

About the Department:
The primary responsibility of the team is to manage planning of all regulatory LCM submissions worldwide and ensure efficient processes across areas in RA CMC & Device.

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