Strategic Regulatory Affairs CMC Professional

1 week ago


Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

We're committed to creating an inclusive culture that celebrates diversity and promotes equality of opportunity for all job applicants. At Novo Nordisk, we recognize that being the best company in the world is no longer good enough; we need to aspire to be the best company for the world.

About the Role

As a CMC Regulatory Specialist, you'll contribute to external publications and advocacy to shape future global regulatory frameworks. You'll also participate in multidisciplinary project groups, working closely with stakeholders across multiple functions in a global environment.

Key Responsibilities

- Provide strategic, tactical, and operational regulatory input to projects - Lead activities for synthetic small molecule projects in late development - Drive scientific and regulatory discussions across the portfolio - Apply regulatory intelligence and establish strategy for submission of clinical trial applications (CTAs) and marketing authorizations (MAAs) - Submit regulatory files and respond to questions from health authorities - Evaluate process challenges and propose new ways to support projects - Identify phase-appropriate regulatory risks and develop mitigation strategies - Perform regulatory assessment of planned or implemented CMC changes based on global regulatory guidelines



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