Regulatory Affairs CMC Professional - 12 months maternity cover

you, if you are passionate about drug development and want to be a subject matter expert in a leading international organization as you will have the opportunity to take the lead and set the strategic direction in a project of great importance to Novo Nordisk’s growth on a global level.
 
The position 
As a Regulatory Affairs CMC Professional, you will have the opportunity to work on a late-stage project, supporting the preparation for upcoming BLA/MAA/NDA submissions.  You will be in the center of project planning and execution in close collaboration with your RA CMC team – Responsible for planning and coordinating regulatory documentation related to the submission the drug. You are expected to demonstrate drive and eagerness to learn. Other re-sponsibilities may include:

• Execute the strategies developed by experienced colleagues in accordance with CMC de-velopment activities 
• Help turn scientific progress into regulatory pathways.
• Apply CMC regulatory intelligence to develop robust regulatory strategies
• Identifying as well as improving regulatory CMC practices, processes and approaches re-lated to regulatory CMC documentation and strategies
• Act as a point of contact for assigned activities, drive discussions, and ensure that rele-vant information is conveyed to the rest of your RA CMC team

Our commitment to innovation also applies to the way we work. We therefore embrace the hy-brid workplace, blending home office and on-site work, preferably in Søborg, Denmark, where the global RA CMC & Device department is based.

Qualifications
To succeed in the role, we expect you to have:

• An academic degree in science, pharmacy, biology, or similar 
• At least, 1-2 years of relevant experience in the pharmaceutical industry, particularly with-in a CMC-related area.
• A good scientific and technical mindset, along with a thorough understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytics, and quality assurance)
• The ability to communicate topics related to protein chemistry, analytical chemistry, manufacturing of drug substances, and drug products scientifically and professionally with your colleagues
• Excellent communication skills, both written and spoken, with fluency in English.

In this role, your collaborative skills will be well-trained and further developed, allowing you to build an extensive internal network.

On a personal level, you are a curious, well-organized, and proactive problem solver who thrives in dynamic environments. With a can-do attitude and strong teamwork skills, you adapt to change effectively while bringing innovation and independence to overcoming.

About the department
Novo Nordisk Regulatory Affairs CMC & Device makes medicine available to patients around the world by ensuring fast regulatory submissions and approvals in all our global markets. The RA CMC Biotech and Rare Disease area consists of approximately 70 highly skilled, dedicated col-leagues with diverse backgrounds and experiences who are involved in every Regulatory CMC aspect concerning products and projects in these areas. As Novo Nordisk’s product portfolio grows, we are developing and implementing highly diverse CMC solutions to complex manufac-turing processes; therefore, we are looking to expand our team of experts within RA CMC.

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 regarding the role, please contact Nermin Ipek at +45 30790261.

Deadline 
12 March 2025.
 
Please note that applications will be reviewed continuously, and interviews will be planned as soon as a suitable candidate is identified.

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.