Jobbeskrivelse

Placering
Søborg, Denmark

Jobkategori
Regulatory

Dive into the dynamic world of Regulatory Affairs at Novo Nordisk. Our team is devoted to gaining global approvals for our innovative medicines. With a deep scientific understanding, a patient focus, and expertise in managing diverse stakeholder interests, every day with us is both rewarding and intellectually enriching.

We are currently looking for a Semaglutide Cardiovascular Outcomes Trial (CVOT) RA (Regulatory Affairs) Specialist with a strong scientific background and a genuine interest in being part of the future within cardiometabolic and renal disease. Apply now for this life-changing opportunity

The position
As a Semaglutide CVOT RA Specialist you will be responsible for driving several regulatory tasks with challenging and often overlapping timelines. You will be working closely with Global Regulatory Lead during worldwide submissions. Specifically, you will have a critical responsibility in the submission... and approval process, and work with the cross-functional teams toward forming strategies and responding questions to major Health Authorities, and by that, securing progress toward regulatory approvals.

You will be involved in critical CVOT strategic discussions in the project, where you will be expected to contribute to regulatory strategies and tactics, be proactive and bold, challenge the discussions and contribute to business-critical decisions.

Furthermore, your interactions will span across project management, medical and non-clinical specialists, statisticians, and medical writers. Additionally, you may contribute to projects aimed at enhancing and streamlining regulatory procedures throughout the organization.

An integral aspect of your role will be mentoring junior colleagues, thereby sharing your knowledge and expertise to foster their growth. Your commitment to this, along with your contributions, will significantly contribute to the high-performance standards of the regulatory project team.

Qualifications
To succeed in this role, we expect you to have:
• Master of Science degree in pharmaceutical or life sciences with 6-8 years relevant experience and/or Ph.D. with 4-5 years of relevant working experience
• Solid practice of handling regulatory documentation for pharmaceutical development within the quality, non-clinical or clinical area
• Experience interacting directly with regulatory authorities on an international scale
• Strong negotiation skills and a sound understanding of business and data
• Fluent written and spoken English

As a person, you are well-organised and have solid problem-solving capabilities, just as you show a winning attitude and never lose your strategic focus. You can keep your spirits high even when under pressure. Your adept communication skills span across all levels of an organization.

You are proficient in providing guidance, leadership, and motivation, you adeptly steer your team towards shared objectives. Simultaneously, you actively contribute as a collaborative team member, readily assisting your colleagues.

About the department
RA Semaglutide is responsible for defining and driving regulatory strategies for our Semaglutide projects in all phases of development. We are dedicated and highly engaged employees in the department belonging to the RA Semaglutide area. We work as an integrated part of the global development and research projects and play a key role in the cross-functional teams. We are responsible for the Semaglutide regulatory strategy and provide regulatory expertise and tactics to the product development plans. We drive label development, health authority interactions and clinical trial applications. We have a strong collaboration with our affiliates and global stakeholders in the regulatory teams.

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 further information, please contact the Hiring Manager - Helene Nordahl at +45 30750291.

Deadline
10 September 2023.

Please note that applications will be reviewed continuously, and interviews will be planned as soon as a suitable candidate is identified.

You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV.

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
Copenhagen Denmark

Salary Criteria