Regulatory Affairs Strategist for Global Planning and Optimization
13 hours ago
Unlock your potential as a Regulatory Affairs Specialist in a dynamic role at Novo Nordisk A/S, where you will drive the planning and optimization of global regulatory strategies.
About the Role
We are seeking a highly skilled and experienced professional to join our Regulatory Affairs CMC & Device team in Søborg, Denmark. As a Strategic RA Planning Specialist, you will be responsible for driving governance setup for prioritizing regulatory activities across RA CMC & Device, affiliates, and Product Supply. You will ensure strategic long-term planning for life cycle management variations to optimize supply and lead RA Planning improvement initiatives.
Main Responsibilities
- Drive governance setup for prioritizing regulatory activities across RA CMC & Device, affiliates, and Product Supply
- E nsure strategic long-term planning for life cycle management variations to optimize supply
- Lead RA Planning improvement initiatives
- Maintain a comprehensive overview of all planning activities
- Act as a project manager to create simulations and scenarios for long-term planning of LCM projects in RA
- Ensure information flow and alignment across projects and therapeutic areas
Requirements
We require a minimum of a Master's degree in life sciences or a PhD. For this role, we are seeking candidates with more than 5 years of experience in a relevant field, such as regulatory planning, a strong understanding of global regulatory requirements, and/or experience with supply planning or similar. Expertise in handling RA variations in life cycle management of pharmaceutical products is also essential.
About the Department
You will be part of the RA Planning and Processes department in the Submission Excellence area of RA CMC & Device. Our team currently comprises 9 colleagues who manage planning of all regulatory LCM submissions across the world and ensure efficient processes across areas in RA CMC & Device. Our main stakeholders are Product Supply, Supply Chain, Regulatory functions in global affiliates, and headquarters primarily within RA CMC & Device.
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