CMC Regulatory Specialist

Job Summary Your new role Your responsibilities Regulatory submissions to health authorities worldwide

• Lead submission planning by applying regulatory intelligence and developing robust regulatory strategies across global markets
• Prepare, maintain and submit regulatory files including MAA/NDA/BLA, NBOp, CE, CTA/IND, device files, site master files, renewals, post-approval changes and commitments
• Respond to questions from health authorities and manage ongoing interactions with affiliates to ensure alignment and compliance

Regulatory interactions with health authorities

• Plan and conduct regulatory interactions with health authorities, including preparation of meeting requests, meeting packages, rehearsals and formal meeting minutes
• Provide strategic input to affiliates in preparation for health authority interactions
• Represent Novo Nordisk externally, actively communicating within your field of expertise

RA matrix team membership and cross-functional collaboration

• Represent the Regulatory Affairs function in RA matrix teams, ensuring alignment of planning and strategy across areas
• Ensure effective information flow to the matrix team and broader stakeholders
• Serve as RA representative in International Study Groups, stakeholder working groups, core groups and expert groups

Innovation, compliance and continuous improvement

• Drive innovation and optimisation projects within the regulatory space
• Evaluate guidelines, requirements and their impact on projects
• Conduct impact assessments of change requests and deviations
• Act as Product Responsible for Regulatory Compliance
• Act as substitute for more senior regulatory roles when needed

Your department Your skills qualifications

• A Master's degree with typically more than 12 years of relevant experience, or a PhD with typically more than 5 years of relevant experience across several regulatory disciplines. A Bachelor's degree with a minimum of 10 years of relevant experience across several qualifiers may also be considered
• Solid knowledge of regulatory science and requirements across major markets (EU, US, China, Japan), with experience spanning areas such as early- and late-stage drug development, life cycle management, health authority interactions and CMC development
• Strong strategic mindset with proven ability to translate regulatory strategies into ambitious goals, handle ambiguity and make bold, well-informed decisions in complex stakeholder landscapes
• Excellent planning, coordination and stakeholder management skills, with the ability to structure complex tasks, eliminate unnecessary complexity and drive alignment across functions and cultures
• Fluency in written and spoken English, combined with proven negotiation skills and the ability to represent Novo Nordisk at an international level of expertise

Experience Level

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