Regulatory Affairs CMC Specialist

We are expanding our product and project pipeline in Novo Nordisk and are looking for an engaged Regulatory Affairs Chemistry, Manufacturing and Control (RA CMC) Specialist with expertise in Biologics to join the Early Development department in the RA CMC Biologics & Rare Diseases area within Novo Nordisk. If you are looking for a rewarding career that makes a difference in patients' lives in a fast paced, dynamic environment, where you will lead, set strategic direction in projects and be a regulatory affairs expert in a growing organization, then this might be the job you are looking for.

The position

As a CMC Regulatory Specialist, you will provide strategic, tactical, and operational regulatory input to projects. You will lead the regulatory CMC activities for Biologics projects in early development as well as drive scientific and regulatory discussions across our portfolio. In this role, you will work closely with stakeholders across multiple functions in a global environment.

In addition, you will also be responsible for the following:

• Applying regulatory intelligence and establishing strategy for submission of clinical trial applications (CTAs) as well as marketing authorisations (MAAs) and variations
• Submission of regulatory files and responding to questions from health authorities
• Ensuring the preparation, review and submission of pre-meeting packages for health authority meetings as well as conducting rehearsals and participating in the meetings
• Addressing process challenges by performing analyses and proposing new ways to support projects
• Identifying phase appropriate regulatory risks and developing mitigation strategies
• Performing the regulatory assessment of planned or implemented CMC changes based upon global regulatory guidelines
• Contributing to external publications and advocacy to shape future global regulatory frameworks

Our commitment to innovation also applies to the way we work: We embrace the hybrid workplace where you can balance working from home and the office. 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

A Master and/or Ph.D. degree in life sciences with regulatory CMC experience either from the pharmaceutical industry or from a health authority.

A minimum of 8+ years of experience within biologics is preferred, as well as experience in the following areas:

• In-depth knowledge of regulatory CMC requirements for clinical trial /investigational new drug applications
• In-depth knowledge of regulatory CMC requirements for marketing authorizations in the EU, US and other major countries
• Extensive experience working with Biologics, including process design, analytical methodology, control strategy, process validation and stability/shelf-life
• Understanding of phase appropriate drug development activities and milestones

You have excellent analytical skills, systematic approach to identify root causes and propose innovative ways to solve problems. You also can communicate complex scientific procedures with technical proficiency both orally and in writing. Advanced level written and spoken English is a prerequisite.

As all work takes place in multidisciplinary project groups, we expect you to be a dedicated team player, find it easy to build working relationships, and gain recognition amongst stakeholders with your proactiveness, integrity, and communication skills. The role requires the ability to work effectively with people from different functions and organisational levels, calling for high cultural awareness and the necessary skills to encourage and influence colleagues, governance, and key stakeholders. You also thrive with the challenging reality of international communication across time zones, cultures, and circumstances.

About the department

RA CMC Biologics & Rare Diseases – Early development & Life cycle management is a department comprised of 10 colleagues, working in projects within early to late phases of drug development as well as early LCM. We are responsible for driving the regulatory affairs CMC strategies and submission activities related to the drug projects based on the Biologics regulatory framework.

We strive to be the best in the industry, delivering safe and innovative products to the patients by strategic business partnering, proactive collaboration with health authorities and efficient operations.

Our organisation is dynamic and there is focus on improving work processes both in relation to implementation of new regulations and thinking “out of the box”, setting bold regulatory strategies enabling us to go above and beyond to the benefit of the business and the patients we serve.

Our work is essential to keep bringing innovative, patient-centric, and best-in-class solutions to our patients. That calls for team spirit, collaborative minds, skilled colleagues, and a great focus on knowledge-sharing. So, look forward to being surrounded by talented, cooperative, and embracing teammates in a strong and empowering culture.

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, please contact Dorte Lunøe at +45 30790217

Deadline

20 January 2025.

Candidates will be evaluated on an ongoing basis, so we encourage you to submit your application as soon as possible.

Please submit an English version of your resume and include a few sentences about your motivation towards this position.  To ensure an efficient and fair recruitment process, please refrain from adding a photo in 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.