Director of Regulatory Affairs for CMC Biologics

2 weeks ago

Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time
Director of Regulatory Affairs for CMC Biologics & Rare Diseases

Category: Project Management & Agile

Location: Søborg, Capital Region of Denmark, DK

Are you an experienced purpose-driven and business-minded second line leader with extensive expertise in drug regulatory affairs? Do you excel in a dynamic environment and want to be part of a rapidly growing organisation dedicated to improving the lives of people living with serious chronic diseases? If so, read on and apply today for a life-changing career.

The position
The RA CMC organization is growing, and we are strengthening our leadership team with a new Director with strong experience and interest in Regulatory Life Cycle Management. As the Director for RA CMC Biologics & Rare Diseases, you will play a pivotal role in shaping the future of RA CMC. We are looking for a dynamic and visionary leader to spearhead our team as the Director of a newly established area. This is your chance to significantly impact and develop an area responsible for regulatory CMC strategies, driving excellence in our pipeline, and delivering regulatory approvals in close collaboration with key stakeholders in Product Supply/CMC and Regulatory Affairs functions. You will report to the Vice President of RA CMC & Device and be part of the leadership team in RA CMC Biologics & Rare Diseases and the extended leadership team in RA CMC & Device. In this position, you will be able to influence the future way of working in the Novo Nordisk Regulatory CMC and Device function.

In this role you will:

  • Be accountable for the overall development and execution of regulatory CMC strategies and global approvals for the Biologics & Rare Diseases product portfolio.
  • Inspire, empower, and develop leaders and employees with a focus on optimising the way we work and stakeholder collaboration.
  • Set strategic direction and drive performance leveraging your leadership expertise and business understanding.
  • Build and maintain strong relationships with key stakeholders, influence across levels, and value diverse perspectives.
  • Connect with peers in the industry and ensure engagement with relevant industry/pharma associations while keeping up with changing regulatory requirements.

You will be working in a multicultural and global setting and must expect some travelling days per year.

Qualifications
To thrive and succeed in this role we would expect you to have:

  • A Master of Science degree in natural sciences such as engineering, pharmacy, chemistry or similar.
  • 10+ years of experience as a leader and minimum 5 years as second line leadership is required.
  • 10+ years of experience from the pharmaceutical industry within Regulatory Affairs.
  • Experience from working in a global function with manufacturing or CMC, QA or a function collaborating closely with regulatory CMC is an advantage.
  • Experience interacting with key stakeholders at senior management level in production, CMC and production development, R&D, and affiliates globally.
  • Strong negotiating skills, clear communication, and comfort engaging with senior management.

Overall, this position is right for you if you are known as a leader who excels in driving change and innovation. You inspire your surroundings to exceed their best, and you find the right balance between progress and quality. You can set direction in business-critical processes and navigate in an environment where decisions are often quick and ever-changing. You are ambitious, possess strong personal drive and exhibit a high level of integrity.

About the department
The newly established RA CMC BRD Development Projects & LCM is one of three areas in RA CMC Biologics & Rare Diseases, which is a VP area organized in the RA CMC & Device organization with 270 employees. As Director, you will lead and develop leaders and specialists organized in three departments with more than 30 colleagues in Søborg, with a wide range of expertise and experience. The area is responsible for regulatory CMC development activities within the Novo Nordisk Biologics and Rare Diseases pipeline and early LCM of marketed products.

RA CMC & Device has an increasingly important function in Novo Nordisk due to the corporate ambition of bringing new products and innovation progressively faster to market by shortening development timelines and optimise and expand production capacities to help many more patients. The function is represented across the value chain in governance and project teams (matrix teams) and acts as an important business partner by soliciting tough decisions based on regulatory requirements, business needs, and patient safety.

Working at Novo Nordisk
Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 69,000 employees around the world. We recognise the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we're working toward something bigger than ourselves, and it's a collective effort. Join us Together, we go further. Together, we're life changing.

Contact
For further information, please contact Thomas Ravn, Regulatory Vice President RA CMC Biologics & Rare Diseases, at +45-30799542.

Deadline
17. February 2025

You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or 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.

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