Global CMC Lead - Small Molecule Registration

RBW Consulting LLP; United Kingdom; On-site; GBP 90,000 - 120,000; Full time

Job summary

RBW Consulting LLP is seeking a Senior Regulatory Consultant to lead global Regulatory CMC strategy for a late-stage small molecule programme approaching Marketing Authorisation. You will partner with technical development, quality, manufacturing and supply chain to shape dossiers and ensure timely delivery.

In this role, you’ll drive health authority interactions, develop risk mitigations, oversee Module 3 documentation and coordinate cross-functional teams across international markets.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Regulatory CMC expertise

Late-stage development

Global submissions

FDA EMA ICH knowledge

Module 3 documentation

Stakeholder influence

Job description

RBW Consulting LLP is seeking a Senior Regulatory Consultant to lead global Regulatory CMC strategy for a late-stage small molecule programme approaching Marketing Authorisation. You will partner with technical development, quality, manufacturing and supply chain to shape dossiers and ensure timely delivery.

In this role, you’ll drive health authority interactions, develop risk mitigations, oversee Module 3 documentation and coordinate cross-functional teams across international markets.