Regulatory Affairs Planning Expert
1 day ago
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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