Do you want to be part of a growing organization, contributing to the success of Novo Nordisk’s expanding product portfolio? Are you passionate about regulatory guidelines and committed to ensuring high-quality submissions? Do you thrive in a diverse, collaborative environment where teamwork and structure drive success? Then you might be our new Regulatory Affairs (RA) Professional in RA CMC & Device, handling RA CMC activities for our marketed Oral Products at Novo Nordisk.
Apply today and join us on this exciting journey for a life-changing career!
The Position
As a Regulatory Affairs professional, you provide the key connection between scientists and Health Authority regulators, hence playing a key role in making medicines available to patients around the world by ensuring fast and successful regulatory submissions and approvals in all global markets. You will join an experienced, very knowledgeable, lively and friendly hybrid collaborating team with everyone working with an Oral product. The team is focused on RA CMC life-cycle management activities, and you would be joining a RA CMC product group working out of Soeborg, Denmark and Bangalore, India.
Your main responsibilities will include:
- Plan, coordinate and execute regulatory submissions.
- Create, plan and coordinate (at times – bold) submission timelines in collaboration with CMC subject matter experts (SME), affiliates and other key stakeholder.
- Define and drive needed updates of the Quality (M3) drug product documentation package needed for a submission, including review & approve the M3 documentation, support preparation of regional documentation, drive QnA rounds in close collaboration with SMEs, and (when applicable) drive creation of the CMC part of Health Authority meeting packages.
- Additional aspects of the position include identifying as well as improving RA CMC practices, processes, and approaches related to RA 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.
Qualifications
To succeed in this role, you should have:
- A Master’s degree and/or PhD in a relevant field
- At least 3-4 years of experience within the pharmaceutical industry, preferably in areas such as manufacturing, product supply, process development, CMC development, analytics, or quality assurance
- Strong communication skills, as collaboration in multidisciplinary project teams is essential
- A proactive, positive, and professional approach to challenge
- Enjoy working in diverse teams with colleagues from various backgrounds
- High proficiency in English - written as well as spoken
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 Area and Department
RA CMC & Device consists of four areas with two working specifically with RA CMC. We are skilled, collaborative, friendly, and dedicated colleagues with diverse backgrounds and experience, and you will be part of a dynamic and committed organization handling many projects in different phases of development. Also, as Novo Nordisk’s product portfolio grows, the RA CMC & Device organization is also looking into developing innovative solutions to increasingly complex CMC manufacturing strategies and regulatory requirements.
There is a high focus on individualized onboarding, flexibility, empowerment, and individual development in the area. Well-being and psychological safety are also a major focus and are considered essential for the working environment. We strive for a modern way of working, including friendly colleagues, camaraderie, and 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.
Working at Novo Nordisk
At Novo Nordisk, we do not wait for change. We drive it. We are 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 are all working to move the needle on patient care.
Contact
For more information regarding the role, you are welcome to contact Michala Ebba Victor on emev@novonordisk.com .
Deadline
13 April 2025.
If you are interested in this role, please apply as soon as possible. Applications will be evaluated on an ongoing basis.
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.
Demo
Kalundborg, 51
Full Time