(Senior) Regulatory Affairs Professional, RA Obesity - Maternity cover (Denmark, Søborg)

Jobbeskrivelse
Placering
Søborg, Denmark

Jobkategori
Reg Affairs & Safety Pharmacovigilance

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Do you have a talent for navigating complex regulatory landscapes and driving strategic initiatives? Are you eager to contribute to the rapid development of a high impact program?

If you are passionate about regulatory science and committed to bringing innovative medicines to market, then we invite you to apply and join Novo Nordisk as a (Senior) Regulatory Professional for a 12-month maternity cover.

The position
As a (Senior) Regulatory Professional you will be working within the RA Obesity therapeutic area in one of our key projects that is currently progressing rapidly towards End-of-Phase 2 interactions and initiation of a large phase 3 program in multiple indications within obesity, diabetes and other related conditions. In this role, you will join a large and growing regulatory team and be responsible for driving several regulatory tasks with challenging and often overlapping timelines. Therefore, this role entails interactions with various stakeholders throughout the organization.

Your responsibilities may include:

• Contribute with regulatory expertise to global strategies and tactics
• Develop regulatory documentation for submission to Health Authorities globally, e.g. clinical trial applications, briefing packages, paediatric plans, and responses to health authority questions
• Represent Global Regulatory Affairs in global clinical trial teams and other cross-functional teams
• Collaborate effectively with cross-functional stakeholders such as project managers, medical and non-medical specialists, statisticians, and medical writers

Our commitment to innovation also applies to the way we work. We therefore embrace the hybrid workplace – with a blend of home office in Denmark and on-site office-based work in Søborg, Denmark where our team is based.

Qualifications
To thrive and succeed in this position you should have:

• A master’s degree or PhD within Life Science, Health Science, or a related field
• Solid and hands-on regulatory and/or drug development experience
• Experience from working on clinical development programs from phase 2 to phase 3 is an advantage
• Advanced communication skills in both written and spoken English
• Strong IT/digital skills

Personally, you thrive in fast-paced, collaborative environments and actively contribute to the team's success. You should be well-organised, possess robust problem-solving capabilities, and maintain a strategic focus. A positive, can-do attitude is crucial, as is the ability to keep your spirits high and maintain a healthy sense of humour under pressure.

About the department
RA Obesity is a new and expanding area within Global Regulatory Affairs consisting of 20 dedicated and highly engaged Global Regulatory Leads, Regulatory Specialists and Professionals, organised in two teams. Our department is charged with developing and executing on global regulatory strategies. These strategies are designed to advance projects across multiple indications, from the early stages of development through to worldwide submission and approval of initial Marketing Authorisation applications.

We are responsible for driving label development, facilitating interactions with health authorities, and overseeing regulatory submissions. These submissions include initial marketing authorisation applications, paediatric plans, and clinical trial applications. We maintain strong ties with our affiliates and global stakeholders, fostering a close collaboration that is integral to our operations.

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 to manufacturing, marketing, and sales – we’re all working to move the needle on patient care.

Contact
For further information, please contact Lene Ejstrup Sørensen at [email protected].

Deadline
16 February 2025

You do not need to attach a cover letter to your application, but please include a few lines about your motivation in your resume or CV. Please assist us in maintaining a fair and inclusive selection process by not attaching a photo to your application.

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.