Expert in Regulatory Affairs
5 days ago
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Expert in Regulatory Affairs - Primary PackagingCategory: Reg Affairs & Safety Pharmacovigilance
Location:
Søborg, Capital Region of Denmark, DK
Are you ready to take on new challenges in primary packaging development across emerging therapeutic areas and innovative products? Would you like to use your project management skills to drive primary packaging submission activities in different projects across our portfolio? Novo Nordisk is seeking an Expert in regulatory affairs related to primary packaging to join our Regulatory Affairs (RA) Device and Digital Health (DH) department. This role offers a multi-disciplinary environment with excellent career growth opportunities, and room to shape the role according to your interests and specialization.
The positionNovo Nordisk is evolving its portfolio in medical device and drug-device combination products across an exciting array of innovative products, including biopharmaceuticals and new delivery systems. We are therefore looking for a Regulatory Affairs Expert in our area to drive the primary packaging submission activities. In this role you will have the opportunity to:
- Drive submission activities related to primary packaging in cross-functional RA matrix teams and device project teams.
- Collaborate closely with colleagues across the organisation and lead key activities from early development through to clinical trials and up to marketing applications.
- Ensure alignment of planning and strategy across areas for primary packaging, represent Novo Nordisk internally and externally, and coach and mentor junior colleagues.
- Establish a global network and enhance your knowledge by participating in innovative medical device and drug-device combination product projects involving highly skilled people – all experts within their field.
- Shape your role according to your interests and specialization.
- Work in a fast-paced environment with tight deadlines and deal with the challenging reality of international communication across different time zones, cultures, and circumstances. The atmosphere is informal, and good humour is always welcome.
Our commitment to innovation also applies to the way we work: We embrace a hybrid workplace, with a blend of in-office and remote work.
QualificationsTo succeed in this role, we expect you to have:
- An academic degree such as a Master's degree within engineering, pharmacy, or a relevant field, along with substantial global work experience involving primary packaging materials regulations.
- Knowledge of international legislation and standards, experience in the pharmaceutical industry, and a track record of working with NDA, BLA, or MAA submissions are advantageous.
- Strong project management skills, outstanding communication abilities, and a proactive, solution-oriented mindset are essential.
- Fluent in written and spoken English.
About the department
Regulatory Affairs Device & Digital Health is part of the Regulatory Affairs CMC & Device Area in Novo Nordisk. In Regulatory Affairs Device & Digital Health, we are responsible for submission planning including applying intelligence and developing regulatory strategy for the device constituent of drug-device combination projects, medical devices and primary packaging, to ensure minimum time to market and thus patients. This includes evaluating applicable guidelines, requirements and using external relations and network in your day-to-day work, as well as planning and conduct of regulatory interactions with health authorities.
Working at Novo NordiskAt 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.
ContactFor further information please contact associate Director, Lykke Forchhammer at +45 3075 1356.
Deadline2nd April 2025
To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. We conduct a thorough manual review of each CV, with a particular focus on the tasks you were engaged in during your tenure at various workplaces. Therefore, please ensure that you provide comprehensive and detailed information. This will enable us to gain a clearer understanding of your roles and responsibilities.
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.
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