Regulatory CMC Lead Belgium
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Make your mark for patients
We are looking for a Global Regulatory Affairs CMC Lead
- Early Development who is strategic, collaborative and adaptable to join our Global Regulatory Affairs, CMC & Devices team, based in any of our Brussels (Belgium), Slough (UK), or Raleigh/Atlanta (US) offices.
About the role
,
You will shape and deliver global regulatory CMC strategies for early-development products, with an initial focus on biologics molecules. Working closely with cross functional teams, you will plan and author high-quality regulatory documentation, engage with health authorities, and support timely approvals that meet patient and business needs. You will also anticipate risks, respond to regulatory questions and contribute to better digital and regulatory processes.
Who you will work with
You will work within the Global Regulatory Affairs, CMC & Devices team that brings together regulatory, manufacturing, quality, and supply experts from around the world. You will collaborate with regulatory leads, technical experts and colleagues across regions to align strategy, source documents and submission timelines. You are also going to represent the function in cross-functional discussions, support external regulatory interactions and share your expertise by coaching colleagues.
What you will do
Define and deliver global and regional CMC regulatory strategies and submissions for assigned early-development products.Lead complex regulatory submissions, ensuring consistency, quality, and alignment with agreed global strategies.
Author and review clear, consistent CMC content, including Modules 2 and 3, responses to Health Authority questions and briefing documents.
Lead or support CMC interactions and negotiations with Health Authorities, helping teams resolve regulatory issues effectively.
Anticipate risks across the product lifecycle and communicate solutions clearly to key stakeholders.
Monitor regulatory changes and use digital tools and structured data to strengthen decisions and lifecycle planning.
Support process improvement initiatives and coach colleagues within the regulatory team.
Interested? For this role, we are looking for the following education, experience and
skills:
Proven contribution to CMC regulatory strategy and authorship of clinical trial submission sections for biological or advanced therapy medicinal products, including accelerated development; marketing authorisation or post-approval submission experience is beneficial.
Experience working with health authorities and supporting regulatory discussions and responses, underpinned by a solid understanding of global development and post-approval requirements, GMP expectations and regulatory practices in at least one ICH region.
Able to analyse technical data, create clear regulatory narratives, identify gaps early and manage traceable content across submissions.
Able to communicates and negotiate clearly, build inclusive cross-functional relationships and remain adaptable as priorities or regulatory expectations evolve.
Demonstrated ability to leverage digital tools, structured data and regulatory information systems to strengthen strategy, submission quality, lifecycle management and decision-making, and to participate in or lead innovation initiatives that drive harmonisation, efficiency and regulatory excellence across global teams.
Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you
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