Senior Regulatory Affairs for Development

Fuldtid

Permanent

Vandtårnsvej 108, 2860 Søborg, Danmark

ID: 2592238

Indrykket for 17 dage siden

Are you able to cut through complexity and drive regulatory strategies for high-impact projects? Would you like to work together with experts across multiple functions in a global environment?

Then join Global Regulatory Affairs in Novo Nordisk and be our new Senior Regulatory Professional for the development project and be part of an exciting environment where engaged people are committed to gain approval of Novo Nordisk’s medicines to bring innovative treatment to patients across the globe. We have a unique combination of scientific insight, patient focus, and the ability to navigate many agendas and stakeholders. That makes RA a truly interesting and dynamic place to work.

Apply now for a life-changing career!

The position

As a Senior Regulatory Professional in our area, you will be part of a fantastic team of 13 people. You will work closely with the Global Regulatory Lead and a team of regulatory professionals and be responsible for driving several clinical regulatory activities within a late-stage development project. You will be a member of cross-functional project and submission teams, and as such, interact with a variety of stakeholders from different departments in Novo Nordisk.

Your tasks will include:

Drive the development and submission of regulatory documentation to Health Authorities e.g. clinical trial protocols, response packages, and briefing packages for meetings with Health Authorities

Contributing regulatory expertise to global strategies, tactics, label scenarios and proactively contributing to project team decisions

Interact with regulatory agencies to ensure timely approval of CTA’s and respond to any questions

Ensure compliance with regulatory requirements and maintain a controlled documentation system

Serve as a regulatory point of contact for affiliates across the globe on CTA’s and represent RA in different cross-functional project teams, including study groups and submission teams

You will report to the Team Leader of RA CagriSema T2D & Amplify and will take an active part in department-related activities, including improvement projects across Global RA.

You will work in a fast-paced environment with tight deadlines where no two days are alike, and you will be supported by friendly colleagues.

Qualifications

As a person, you thrive in a fast-paced working environment with unfamiliar situations and a high degree of complexity. You bring a can-do spirit and are a flexible and change-oriented person who likes to innovate and sees opportunities rather than limitations in challenging situations. You can drive several regulatory tasks simultaneously and still maintain the overview.

We're seeking candidates who fulfil the following prerequisites:

Your background covers a master’s degree in life sciences with 5-6 years of regulatory affairs experience, or other relevant drug development experience from the pharmaceutical industry

You have an all-round understanding of regulatory requirements for drug development including experience with major health authorities such as the FDA and EMA

You are driven by science and innovation and understand complex scientific issues in drug development and will be able to bring them into a regulatory context

You have strong IT/digital skills and thrive in finding new ways to optimise our work

You possess excellent communication skills and are comfortable communicating in both verbal and written English

You build effective working relations in global teams to collaborate as a strategic business partner with our stakeholders

About the department

In RA CagriSema T2D & Amplify department, we contribute to the Novo Nordisk purpose of driving change to prevent chronic diseases by developing new treatment options for chronic conditions like type 2 diabetes and cardiovascular diseases. We are a team of 13 dedicated and highly engaged regulatory leads and professionals with diverse backgrounds and experiences. We value trust, openness, and innovation in our work.

As part of the global research and development project teams, we are responsible for regulatory strategies and tactics, product labeling, health authority interactions, and clinical trial applications. We collaborate closely with stakeholders in affiliates and work in global regulatory matrix teams to execute ambitious plans.

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