Regulatory Affairs Specialist, RA Obesity
5 days ago
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Regulatory Affairs Specialist, RA ObesityCategory: Reg Affairs & Safety Pharmacovigilance
Location:
Søborg, Capital Region of Denmark, DK
Are you passionate about regulatory science and driving innovative regulatory strategies to bring innovative medicines to patients? Do you have strong scientific background combined with regulatory drug development experience?
If yes, then we encourage you to submit your application to become part of a team of dedicated professionals working on one of our key projects within Regulatory Affairs (RA). We are currently expanding as the project progresses rapidly towards End-of-Phase 2 interactions and initiation of phase 3 development in multiple indications within obesity, diabetes and other related conditions.
The position
We are looking for a Regulatory Affairs Specialist to develop and execute the late-stage regulatory strategy for a key project. This role requires strong scientific knowledge and regulatory expertise to evaluate strategies, manage multiple regulatory tasks with overlapping timelines, and collaborate closely with Global Regulatory Leads and cross-functional stakeholders. It offers a broad scope of responsibility, complexity, and professional growth opportunities.
Your key responsibilities may include:
- Provide strategic regulatory input, assess risks, and develop mitigation strategies.
- Represent Global Regulatory Affairs in various cross-functional teams.
- Plan, prepare, and lead Health Authority interactions.
- Develop regulatory documents, including briefing packages, paediatric plans, clinical trial applications, and labeling documents.
- Ensure compliance with evolving regulatory requirements and industry best practices.
- Mentor junior colleagues and contribute to their professional development.
Qualifications
To succeed in this role, we expect you to have:
- An academic degree such as a Master's degree and/or a Ph.D. within Life Science, Health Science or a related field
- Extensive regulatory experience working on global drug development programs (minimum 6-7 years)
- Proven track record of interacting directly with regulatory authorities on an international scale
- Strong negotiation skills and a sound understanding of business and data
- Fluent in written and spoken English
On a personal level, you thrive in a collaborative team setting and proactively contribute to team achievements. You should exhibit excellent organisational skills, robust problem-solving abilities, and maintain a strategic focus. A positive, can-do attitude is essential, along with the capacity to maintain composure and a sense of humour in high-pressure situations. Proficiency in effective communication to facilitate collaboration across all organisational levels is also highly valued.
About the department
RA Obesity is a new and expanding area within Global Regulatory Affairs and will soon consist 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
Deadline
19 March 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.
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