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Regulatory Affairs Lead
1 week ago
Category: Reg Affairs & Safety Pharmacovigilance
Location: Søborg, Capital Region of Denmark, DK
In Global Regulatory Affairs engaged people are committed to gaining regulatory approvals of Novo Nordisk’s medicines across the globe. Our people have a unique combination of scientific insight, patient focus, business understanding, and the ability to navigate many agendas and stakeholders. That makes Regulatory Affairs a truly interesting and challenging place to work.
Apply now for a life-changing career
The position
As Regulatory Affairs Lead - late-stage development project in the RA CagriSema T2D & Amplify department, you will be part of a fantastic team of 13 people. You will work closely with GRL’s, Regulatory Leads and Regulatory Professionals within our department and across our portfolio.
Your main responsibilities include:
- Drive regulatory strategies and clinical regulatory activities for the assigned tracks within a large late-stage development project.
- Be a member of cross-functional project and submission teams, interacting with a variety of stakeholders from different departments in Novo Nordisk.
- As Regulatory Affairs Lead, be accountable for bringing regulatory strategic leadership and innovation to the project and proactively contribute to project team decisions.
- Lead the regulatory activities for the assigned tracks to ensure timely and high-quality regulatory deliverables to the global project teams.
- Work closely with other colleagues, ensure knowledge sharing within- and across projects, and provide sparring and mentoring to others.
- Report to the Senior Director of RA CagriSema T2D & Amplify and actively participate in department-related activities, including improvement projects across Global RA.
Our commitment to innovation also applies to the way we work. We therefore embrace the hybrid workplace – with a blend of home office and on-site work in Soeborg, Denmark where the department is based.
Qualifications
Your background covers a master’s degree within life sciences with 7+ years of relevant experience and/or PhD with 5+ years of relevant working experience, preferably within a pharmaceutical company.
To be successful in this role:
- You have solid regulatory experience including health authority interactions and an all-round understanding of regulatory requirements for drug development.
- You are driven by science and innovation, can understand complex scientific issues, and will be able to bring them into a regulatory context.
- You are well organized with solid project management skills and problem-solving capabilities.
- You have strong IT/digital skills and thrive with finding new ways to optimise our work.
- You are a good communicator and are comfortable using your fluent written and spoken English daily.
As a person, you thrive in a busy environment; bring a can-do spirit and a healthy sense of humour to your work – even when the pressure is on. You build effective working relations and are a flexible and change-oriented person who focuses on opportunities rather than limitations in challenging situations.
About the department
In RA CagriSema T2D & Amplify department, we contribute to the Novo Nordisk purpose of driving change to prevent chronic diseases by developing new treatment options for chronic conditions like type 2 diabetes and cardiovascular diseases. We are a team of 13 dedicated and highly engaged GRL’s, regulatory leads and professionals with diverse backgrounds and experiences.
Contact
For further information, please contact Senior Director Eva Lisby Arp-Hansen at +45 3079 0241.
Deadline
Please apply for the position no later than 2nd of February 2025.
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. Together, we’re life changing.
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