Senior Regulatory Affairs Professional (Denmark, Søborg)

Jobbeskrivelse
Placering
Søborg, Denmark

Jobkategori
Reg Affairs & Safety Pharmacovigilance

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Do you want to play a key role in accelerating the development of our patient-focused products? Are you passionate about regulatory science and executing on regulatory strategies to bring innovative medicines to patients?

If so, we invite you to become a part of our dynamic and forward-looking regulatory organisation. We are expanding our team of highly engaged professionals who play pivotal roles in developing medical solutions and obtaining approvals from regulatory authorities worldwide.

This position is open for placement in either our office in Soberg, Denmark, or Bangalore, India.

Apply now and join us in this exciting journey!

The Position
As a Senior Regulatory Affairs Professional, you will collaborate closely with the Global Regulatory Leads and a team of regulatory professionals, working together to advance late-stage development projects within the Semaglutide Other Serious Chronic Diseases portfolio.

Your key responsibilities will be focused on:

• Become a member of cross functional project teams including clinical study groups and submission teams
• Participate in the development of regulatory documentation for submission to Health Authorities, including briefing packages for meetings with Health Authorities, and regulatory files for marketing authorization, working with affiliates to ensure alignment between local and global regulatory strategies and timely preparation of documentation
• Responsible for clinical trial applications
• Drive, coordinate and actively follow-up on multiple tasks with challenging and often overlapping timelines
• Interact with stakeholders across various departments, including project management, medical and non-medical specialists, statisticians, and medical writers providing regulatory input and contributing to project discussions and decisions

Furthermore, you will work in a dynamic, fast-paced environment with tight deadlines and deal with the challenging reality of international communication across time zones, cultures, and circumstances. We strive for an informal and positive atmosphere.

We embrace the hybrid workplace – with a blend of on-site office-based work in Søborg, Denmark, or Bangalore, India, and a home office in Denmark or India.

You will report to the Associate Director for RA Semaglutide Other Serious Chronic Diseases.

Qualifications
We set ambitious goals and empower the employees to achieve them. We are therefore looking for a person who is strong in driving their own activities, though still values working in a team environment and actively contributes to the team’s success. We are looking for a person who is well-organized, comfortable speaking their mind, and enjoys a challenging problem. A positive, can-do attitude is crucial, as is the ability to keep your spirits high and maintain a healthy sense of humor under pressure. You have a professional and personal impact that is reflected in your desire to take initiative and finally, you must have a willingness to take responsibility for your own learning.

We expect an ideal candidate to have the following:

• Master and/or PhD in science, pharmaceutical, or health science or relative field with typically some relevant working experience (3-4 years) within Regulatory Affairs or other relevant area in drug development or Bachelor with 5-7 years relevant experience or equivalent knowledge through relevant practical experience in Regulatory Affairs.
• Experience using MS Office tools; knowledge of Veeva Vault Rim would be an advantage
• Ability to communicate in fluent English (both written and spoken)

About the department
The RA Semaglutide Other Serious Chronic Diseases department is responsible for projects within Alzheimer’s disease and MASH. We are defining, implementing, and executing regulatory strategies and play a key role in the cross-functional project teams. We drive label development, health authority interactions, clinical trial applications, and preparation for global marketing authorisations 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 to manufacturing, marketing, and sales – we’re all working to move the needle on patient care.

Contact
For further information, please contact Pia Lorenzen at +45 30 75 18 98

Deadline
20 May 2024

Applications will be reviewed on an ongoing basis, so we encourage you to apply as soon as possible.

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.

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.