Global CMC Strategy Lead – Late-Stage Small Molecule

RBW Consulting; United Kingdom; On-site; GBP 110,000 - 150,000; Full time

Job summary

RBW Consulting in the United Kingdom is seeking a Senior Regulatory Consultant – Small Molecule Registration (Lead) to own the regulatory CMC strategy for a late-stage programme approaching Marketing Authorisation.

You'll lead global CMC strategy, coordinate with development, quality, manufacturing, and supply chain, and drive MA submissions and Health Authority interactions to deliver a high-quality dossier on time.

Qualifications

• Significant experience within Regulatory Affairs CMC.
• Involvement in late-stage development programmes and Marketing Authorisation submissions.
• Strong knowledge of FDA, EMA and ICH requirements.

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 leadership

Global regulatory strategy

Stakeholder management

Regulatory submissions

Module 3 documentation

Job description

RBW Consulting in the United Kingdom is seeking a Senior Regulatory Consultant – Small Molecule Registration (Lead) to own the regulatory CMC strategy for a late-stage programme approaching Marketing Authorisation.

You'll lead global CMC strategy, coordinate with development, quality, manufacturing, and supply chain, and drive MA submissions and Health Authority interactions to deliver a high-quality dossier on time.