CMC Regulatory Specialist

Job description

Shape regulatory strategies that bring life-changing medicines from development through approval and into the hands of patients across the globe. **Your new role** As a CMC Regulatory Specialist, you will take ownership of complex regulatory processes that directly enable Novo Nordisks medicines to reach patients worldwide. Operating at the intersection of science, strategy and global compliance, you will navigate diverse regulatory landscapes and drive submissions across major markets. Your work will span the full product lifecycle from early development through post-approval requiring both deep technical expertise and strategic agility. Your responsibilities will span the following key areas: *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 new department** In Research Development, youll be part of a unit that explores bold scientific ideas and advances them into clinical testing. We combine curiosity, AI tools, and human data to develop transformative therapies. Through collaboration and operational excellence, we shape and deliver an innovative pipeline to meet future patient needs. Within RD, you will join a regulatory team focused on Chemistry, Manufacturing and Controls (CMC), where you will work alongside experienced regulatory professionals dedicated to navigating the global regulatory landscape. The team operates with a high degree of cross-functional collaboration interfacing with development, manufacturing, quality and commercial stakeholders to ensure our products meet the highest regulatory standards across all major markets. **Your skills qualifications** We are looking for a seasoned regulatory professional who thrives in complexity, brings strategic thinking to every interaction and is energised by navigating global regulatory environments. You will bring: - Regulatory submissions to health authorities worldwide - Regulatory intelligence - Regulatory strategies - Health authority interactions - Regulatory file preparation and submission (MAA/NDA/BLA, NBOp, CE, CTA/IND, device files, site master - Cross-functional collaboration and stakeholder management - Regulatory impact assessment - Regulatory compliance leadership - Negotiation skills Disclaimer : This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.