Regulatory Affairs Lead - Cardiovascular Outcome Trials (Denmark, Søborg)

Jobbeskrivelse
Placering
Søborg, Denmark

Jobkategori
Reg Affairs & Safety Pharmacovigilance

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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 rewarding and intellectually enriching.

We are currently looking for Regulatory Affairs (RA) Specialist with a strong scientific background and a genuine interest in contributing to future developments within cardiometabolic and renal disease. Apply now for this life-changing opportunity!

The position
As a Regulatory Affairs Lead for semaglutide cardiovascular outcome trial, you will be responsible for driving several regulatory tasks with challenging and often overlapping timelines. Moreover, your interactions will span across project management, medical and non-clinical specialists, statisticians, and medical writers, and regional/local regulatory counterparts.

Your key responsibilities will include:
• Collaborating closely with the Global Regulatory Lead to facilitate worldwide submissions and ensure successful approval, with a particular focus on type II variation submissions, Q&As, roll-out activities
• Driving cross-functional teams to develop strategies and address inquiries from major Health Authorities, driving regulatory approval progress
• Actively contributing to strategic project discussions, shaping regulatory strategies, challenging assumptions, and influencing critical business decisions.
• Contributing to initiatives aimed at optimising regulatory processes across the organization
• Mentoring junior colleagues by sharing your expertise to support their professional development

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

Qualifications
To succeed in this role, we expect you to have:
• An academic degree such as master's degree and/or a Ph.D. within Life Science, Health Science or a related field coupled with a substantial and proven track record of relevant working experience
• Solid practice with handling regulatory documentation for pharmaceutical development within the quality, non-clinical or clinical areas
• Experience interacting directly with major health authorities on a global level (including FDA, EMA, PMDA, NMPA)
• Strong negotiation skills and a sound understanding of business and data
• Experience working within the diabetes or obesity areas is an advantage
• 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 cross-functional teams. We are responsible for the Semaglutide regulatory strategy and provide regulatory expertise and tactics to 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 [email protected].

Deadline
9th of February 2025.

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.