Senior Manager, Global Regulatory Affairs CMC (all genders)

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:

• University degree in Life Sciences such as Biochemistry, Biotechnology or a related discipline (minimum MSc or equivalent degree), higher degree preferable (e.g. PhD in a scientific discipline)
• 4 to 9 years of CMC regulatory and/or CMC technical experience within the pharmaceutical / biotech industry (e.g. in regulatory affairs, quality control, analytical development or manufacturing / process development)
• Ability to develop and prepare successful regulatory CMC strategies for variations, renewals, or new registrations (new MAAs)
• Experience in preparation and management of regulatory CMC documentation, such as a full international submission (new product application) or complex variations
• Practical experience in one of the following areas: manufacturing process development, technical transfers, validation or analytical development, control strategies
• Sound understanding and in-depth knowledge of global pharmaceutical legislation
• Ability to work in teams, good interpersonal skills
• Assertive, proactive, flexible, speak up personality
• Ability to think strategically
• Excellent written and spoken communication skills in English (knowledge of other European languages such as French, Italian or German is an asset)