RBW Consulting
Senior Regulatory Consultant - Small Molecule
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Senior Regulatory Consultant – Small Molecule Registration (Lead)
Late-Stage Small Molecule | Global Regulatory Strategy | MAA Preparation
A rare opportunity has arisen for an experienced Regulatory CMC leader to take ownership of a high-profile late-stage small molecule programme approaching Marketing Authorisation submission.
This role sits at the heart of a global development team and offers the chance to shape CMC regulatory strategy for a key asset at one of the most exciting stages of the product lifecycle. You'll be the driving force behind the global CMC regulatory roadmap, partnering with technical development, manufacturing, quality, supply chain and regulatory stakeholders to ensure successful delivery of a complex registration programme.
The Opportunity
This is more than a traditional Regulatory Affairs role. You'll act as the strategic CMC lead for a late-stage development asset, defining and executing global regulatory strategy, preparing for key Health Authority interactions, identifying risks early, and ensuring a high-quality CMC dossier is delivered on time. Working within a highly collaborative international environment, you'll influence critical development decisions, support accelerated development pathways and play a key role in bringing an important new medicine to patients worldwide.
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What You'll Be Doing
- Lead the global Regulatory CMC strategy for a late-stage small molecule programme.
- Drive preparation and delivery of the CMC components of a Marketing Authorisation Application.
- Act as the CMC regulatory lead for Health Authority interactions, including briefing package development and regulatory responses.
- Partner with Technical Development, Quality, Manufacturing and Supply Chain teams to align development activities with regulatory expectations.
- Provide strategic direction to CMC dossier preparation and technical writing activities.
- Identify regulatory risks, perform gap assessments and develop mitigation strategies.
- Support global submissions across major and emerging markets.
- Represent Regulatory CMC within cross-functional project and governance teams.
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What We're Looking For
- Significant experience within Regulatory Affairs CMC.
- Proven involvement in late-stage development programmes and Marketing Authorisation submissions.
- Strong understanding of small molecule development and registration activities.
- Experience developing and implementing global CMC regulatory strategies.
- Strong knowledge of FDA, EMA and ICH requirements.
- Exposure to international markets including China, Japan, Canada or other global regions would be advantageous.
- Experience authoring or reviewing Module 3 documentation and managing complex CMC submissions.
- Confident communicator with the ability to influence stakeholders across multiple functions and geographies.
- Strong project leadership, problem-solving and risk management skills.
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