Senior Regulatory Professional

Department: RA CMC & Medical Devices  

About the department

Regulatory Affairs CMC play an important role in ensuring that all new Novo Nordisk treatments and devices are developed with compliance and the patients in mind. Liaising between relevant authorities and Novo Nordisk stakeholders, Regulatory Affairs CMC are involved throughout all phases of product development and roll-out. Our people in Regulatory Affairs come from many different academic and professional backgrounds, bringing valuable insights and expertise to the team and the company to ensure minimum time to market. This makes Regulatory Affairs a truly multi-disciplinary place to work with high professional standards, excellent opportunities for fast-paced professional development and career opportunities.

The Position

As a Senior Regulatory Professional, the candidate will be responsible for providing strategic input to RA CMC activities. One should have demonstrated ability to identify better practice and create improvements in methods, techniques, approaches etc. The professional will be required to handle most situations independently but will seek advice and guidance on complex issues. Further responsibilities include handling the change requests, query responses and provide strategic input at various forum representing RA CMC.

• Support preparation and submission of regulatory files, response to questions from health authorities and maintenance of marketing authorization globally.
• Negotiate with the regional affiliates on HA requirements and timelines.
• Manage stakeholders from across the organization including product supply.
• Hands on experience with Veeva vault and RIMS.

The candidate will play a key role in stakeholder management and will be responsible for ensuring appropriate use of communication channels to strengthen relationships with the stakeholders. 

Experience

• 9+ years of experience within Regulatory affairs CMC with Graduate / Postgraduate degree in science/ pharmacy/ medicine etc. 
• Experience of working in a Biologics company is preferred.
• Good understanding of end to end regulatory processes and life cycle management. 
• Strategic mindset with proven negotiation skills. 
• Should be able to convince and put forward the facts confidently. 
• Highly proactive and able to take initiatives & manage multiple priorities. Self-managed, strong personal drive and ability to engage with colleagues and peers towards delivering excellent performance and results.
• High cultural sensitivity and comfortable working with different countries and cultures across multiple time-zones.
• Excellent written/spoken communication skills.

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 72,000 employees around the world. We recognize 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 

If you believe you are a match for the above requirements and are willing to take up the role, please apply here with our online application tool.

Deadline 

Apply on or before: 3rd April 2025.

Disclaimer 
It has been brought to our attention that there have recently been instances of fraudulent job offers, purporting to be from Novo Nordisk and/or its affiliate companies. The individuals or organizations sending these false employment offers may pose as a Novo Nordisk recruiter or representative and request personal information, purchasing of equipment or funds to further the recruitment process or offer paid trainings. Be advised that Novo Nordisk does not extend unsolicited employment offers. Furthermore, Novo Nordisk does not charge prospective employees with fees or make requests for funding as a part of the recruitment process.

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.