Regulatory Affairs Planning Specialist

Are you driven by the challenge of ensuring effective planning for regulatory submissions worldwide? Do you seek an exciting opportunity to shape global regulatory Life Cycle Management (LCM) strategies and contribute to reaching more patients?  

If so, this is your opportunity to make a significant impact in a global, patient-centered organization as we are seeking a highly skilled and experienced Regulatory Affairs Planning Specialist to join our team in Søborg, Denmark. Apply today for a life-changing career! 

The Position 

In this pivotal role, you will have a unique opportunity to have a global impact and collaborate with many different stakeholders across the organization, ensuring structured and aligned regulatory plans for complex LCM projects with strategic importance. You will bring your knowledge of  regulatory requirements, RA CMC LCM variations and understanding of planning based on regulatory lead times into the role. 

The position requires analytical skills and the ability to create overviews of regulatory activities.  

In RA Planning we enable high-level reporting of detailed submission information and develop structured summaries to management and stakeholders around the organization. Focus is needed on following up and providing tactical plans with all affiliates across the world for life cycle management changes. 

In the role you will: 

• Create plans with clear priorities, to support the project needs while complying with regulatory processes 
• Partner with the Supply Chain area in Product Supply, supporting mid- and short-term planning, entailing reliable plans for utilization of the manufacturing network. 
• Develop and maintain structured overviews for submissions and approvals of projects with high strategic importance. 
• Ensure development of close collaboration with product leads and teams in RA Chemistry Manufacturing Control (CMC) & Device. 
• Follow up with senior stakeholders in regional offices and affiliates worldwide on submission plans  
• Lead RA Planning improvement initiatives to enhance efficiency. 
• Coordinate activities across RA Planning. 
• Act as a mentor for colleagues  

The RA Planning Specialist role is an onsite role, with 2-3 days of office presence expected.  

Qualifications 

The person who will thrive in the role is an excellent collaborator with strong stakeholder management skills who is able to navigate in complex environments.  

Other qualifications we are looking for are:  

• Master’s degree with more than 8 years of relevant experience 
• Experience in Regulatory Affairs planning.  
• Fluency in written and spoken English. 
• Expertise in handling RA variations in life cycle management of pharmaceutical products. 

About the Department 

The role will be anchored in Regulatory Affairs (RA) Planning and Processes, a department in the area Submission Excellence in Regulatory Affairs, Chemistry, Manufacturing and Control (RA CMC) & Device. RA Planning & Processes currently comprises 9 colleagues. The primary responsibility of the team is to manage planning of all regulatory LCM submissions across the world, and to ensure efficient processes across areas in RA CMC & Device.  

Our main stakeholders are Product Supply, Supply Chain, Regulatory functions in the global affiliates and headquarter, primarily within RA CMC & Device.  

Submission Excellence is an area working across the portfolio, consisting of 3 departments. We have the overall purpose of driving an ambitious Life Cycle Management agenda to ensure flexibility in the supply network and to act as strategic partners to manufacturing and capacity expansion projects. We have a key role in setting the regulatory strategies for expansion projects, streamlining processes, and ensuring fast and efficient global rollout and approvals.  

The RA CMC & Device organization has 2 main hubs in Søborg, Denmark and in Bangalore, India, comprising approximately 300 colleagues.  

Working at Novo Nordisk 

At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care. 

Contact  

For more information, contact Associate Director Julie Brinck Madsen at +45 30796372. 

Deadline  

Please apply before 27th Feb 2025.  

We will review applications on an ongoing basis, so we encourage you to apply early. 

To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. 

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. 

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.