Regulatory Affairs CMC Expert

We have an exciting career opportunity within our Regulatory Affairs CMC team!

If you want to be a part of an area where we have a high focus on work-life balance, an exciting clinical pipeline, professional development, and great career opportunities, then you could be the one we are looking for.

We are rapidly expanding our product and project pipeline and are looking for experienced Regulatory Affairs CMC Experts to join RA CMC & Device, Biotech and Rare Disease, a part of Novo Nordisk's Development organization.

You will have the opportunity to take the lead, make an impact, and set the strategic direction in projects of crucial importance to Novo Nordisk's patients on a global level.

Apply now for a life-changing career!

The position

As a RA CMC Expert, you will have the opportunity to work within early and late-stage development or preparing for upcoming MAA/NDA/BLA submissions and roll out in the whole world.

You will be the voice of RA CMC & Device, Biotech and Rare Disease and you will turn your knowledge and experience into dynamic regulatory strategies based on current regulatory requirements.   

You will also be responsible for and contribute to the success of our area by:

• Strong command of ICH guidelines, health authority guidelines, and regulations toward CMC manufacturing
• Accelerated regulatory submission strategies (e.g., breakthrough therapy designation, PRIME, etc.)
• New industry and regulatory initiatives (e.g., ICH Q12, digital data transfer, etc.)
• Comparability strategies to support process changes, site changes, formulation changes, etc.
• Integrated combination product (drug product + device) control strategies  
• Applying regulatory intelligence to develop robust regulatory strategies
• Drive the preparation and submission of regulatory files and respond to questions from the regulators
• Manage major market submissions as well rest of world submissions with affiliates
• Support the planning and conduct of regulatory authority interactions
• Provide input to the preparation of health authority meeting requests, meeting packages etc.
• Identifying as well as improving regulatory CMC practices, processes and approaches related to regulatory CMC documentation and strategies

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. The position is based in Søborg, and relocation to Denmark is required for candidates from abroad. We offer relocation assistance for the selected candidate.

Qualifications

What we expect from you:

• Master's degree and/or PhD in a relevant field
• At least 5 years of relevant experience including min. 2-3 years regulatory CMC experience either from the pharmaceutical industry or from a medical agency
• A strong scientific and technical mindset as well as a thorough understanding of related pharmaceutical operations (e.g. manufacturing, process development, analytics, and quality assurance)
• High proficiency in English - written as well as spoken
• Great communication skills as all work takes place in multidisciplinary project groups

You are a dedicated team player, you find it easy to build working relationships, and gain recognition amongst stakeholders with your proactiveness and integrity. Furthermore, you thrive in the challenging reality of international communication across time zones and cultures.

About the department and area

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 highly skilled, dedicated colleagues with very diverse backgrounds and experience. As Novo Nordisk’s product portfolio is growing, we are developing and implementing highly diverse regulatory strategies to the complex manufacturing processes.

There is a high focus on individualized onboarding, flexibility, and empowerment in the area. Development and psychological safety are also a major focus and considered essential for the working environment. We strive for a modern way of working, including friendly colleagues, and a space to be proactive, to learn and to take the initiative to improve and make a difference. We want it to be the best place to work – not only in words, but we walk the talk in this area.

Visit our Regulatory Affairs Careers webpages

For more information about job content and qualifications, please visit the Novo Nordisk Regulatory Affairs Careers webpages at  https://www.novonordisk.com/careers/career-areas/research-and-development/regulatory-affairs-careers.html

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, you are welcome to contact Nermin Ipek (+45 30790261) or Dorte Lunøe (+45 30790217).

Deadline for application   

11 August 2024

Please note that applications will be reviewed continuously, kindly submit your application as soon as possible. 

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