Regulatory Affairs Specialist

Job title:

Regulatory Affairs Specialist

Company:

Novo Nordisk

Job description

Would you like to dive into the dynamic world of Regulatory Affairs in Novo Nordisk? Do you want to be part of a team that is devoted to gaining global approvals for our innovative medicines?

If yes, apply now for this great opportunity!

We are currently looking for a Regulatory Affairs (RA) Specialist with a strong scientific background and a genuine interest in contributing to future developments within cardiometabolic and renal disease.

The position
As a Regulatory Affairs Specialist, you will be responsible for driving several regulatory tasks with challenging and often overlapping timelines for our Semaglutide Cardiovascular Outcomes Trial (CVOT). Moreover, you will interact with multiple stakeholders such as project management, medical and non-clinical specialists, statisticians, and medical writers.

Your main responsibilities will be focused on:

• Collaborating closely with the Global Regulatory Lead to facilitate worldwide submissions and ensure successful approval
• Engaging with cross-functional teams to develop strategies and address inquiries from major Health Authorities, driving regulatory approval progress
• Participating in strategic project discussions, actively contributing to regulatory strategies, challenging discussions, and influencing critical business decisions
• Contributing to initiatives aimed at optimising regulatory processes across the organisation
• Mentoring junior colleagues, sharing your expertise to support their professional development

Qualifications
To be a competitive candidate, you should have:

• A master’s degree and/or a Ph.D. within Life Science, Health Science, or a related field and extensive experience working within Regulatory Affairs
• Solid practice with handling regulatory documentation for pharmaceutical development within the quality, non-clinical or clinical areas
• 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 SEMA is responsible for defining and driving regulatory strategies for our semaglutide & cagrisema projects in all phases of development. We are dedicated and highly engaged employees 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 and cagrisema 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 +45 3075 0291.

Deadline
17 March 2024.

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.

Expected salary

Location

Søborg, Hovedstaden

Job date

Sat, 02 Mar 2024 23:32:18 GMT

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