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A leading company in the biotech industry seeks a CMC Regulatory professional to oversee all regulatory activities for large molecules. This role requires developing comprehensive regulatory strategies, managing submission documentation, and collaborating with cross-functional teams. Ideal candidates will have a strong background in life sciences, with a minimum MSc and several years of experience in regulatory affairs.
Your role:
You are responsible for driving all CMC Regulatory activities for assigned large molecules (biotech) commercial products and projects worldwide. In this role you develop, author and own the relevant Global Regulatory CMC Life Cycle Strategy and all CMC Dossier types, such as NDAs/MAAs, variations, amendments, renewals, annual reports, and answers to health authority questions.
You serve as the contact point for CMC Regulatory topics and act as liaison in-between technical CMC-, quality-, supply- and Regulatory Affairs functions and providestrategic support and advice to the CMC team, the Global Regulatory Strategy Team (GRST), the Global Product Supply Team (GPST), and other cross-functional project teams (e.g. Tech Transfer Project Team). Upon collecting and interpreting country-specific regulatory CMC requirements you translate them into deliverables. You plan and align CMC Regulatory activities and develop submission roll-out and implementation plans, in close collaboration with key stakeholders.
You are the expert for CMC regulations, guidance, regulatory trends and competitive environment, including accelerated pathways, and CMC innovations andlead and participate in internal and cross-functional, international initiatives.
Who you are: