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Regulatory Affairs Specialist
2 weeks ago
We are seeking a highly skilled Regulatory Affairs Professional to join our RA CMC & Device team. As a key member of our organization, you will play a crucial role in ensuring the success of Novo Nordisk's expanding product portfolio.
About the Role
- Plan, coordinate and execute regulatory submissions.
- Create, plan and coordinate submission timelines in collaboration with CMC subject matter experts (SME), affiliates and other key stakeholders.
- Define and drive needed updates of the Quality (M3) drug product documentation package needed for a submission, including review & approve the M3 documentation, support preparation of regional documentation, drive QnA rounds in close collaboration with SMEs, and (when applicable) drive creation of the CMC part of Health Authority meeting packages.
- Identify as well as improve RA CMC practices, processes, and approaches related to RA CMC documentation and strategies.
About You
- A Master's degree and/or PhD in a relevant field.
- At least 3-4 years of experience within the pharmaceutical industry, preferably in areas such as manufacturing, product supply, process development, CMC development, analytics, or quality assurance.
- Strong communication skills, as collaboration in multidisciplinary project teams is essential.
- A proactive, positive, and professional approach to challenges.
- Enjoy working in diverse teams with colleagues from various backgrounds.
- High proficiency in English - written as well as spoken.
About Our Team
The RA CMC & Device organization is a dynamic and committed team handling many projects in different phases of development. We strive for a modern way of working, including friendly colleagues, camaraderie, and space to be proactive, to learn, and to take the initiative to improve and make a difference.
