Remote Senior Regulatory CMC Lead, Late-Stage Small Molecule

RBW Consulting LLP; United Kingdom; Remote; GBP 90,000 - 140,000; Part time

Benefits offered by this job

Remote work

Outside IR35

Job summary

RBW Consulting LLP seeks a Senior Regulatory CMC Project Lead to own the regulatory strategy for a late-stage small molecule asset as it approaches MAA. You will drive global CMC plans, coordinate with internal stakeholders and manage agency interactions to ensure successful submission and lifecycle management.

The role demands 10+ years in Regulatory Affairs CMC, with strong familiarity with FDA/EMA/ICH frameworks and an ability to navigate cross-functional teams across geographies.

Qualifications

• 10+ years' experience in Regulatory Affairs CMC targeted at small molecule late-stage development.
• Proven track record leading CMC components of global Marketing Authorisation submissions.
• Strong knowledge of FDA, EMA and ICH regulatory requirements.

Responsibilities

• Manages global CMC regulatory roadmap for a late-stage asset and drives registration strategy.
• Leads preparation and delivery of the regulatory dossier for submission.
• Oversees agency interactions, risk management and cross-functional collaboration to accelerate approvals.

Skills

Regulatory CMC

Regulatory Strategy

Project Leadership

Stakeholder Management

Global Submissions

Cross-functional Collaboration

Education

Life Sciences degree (MSc/PhD preferred)

Job description

RBW Consulting LLP seeks a Senior Regulatory CMC Project Lead to own the regulatory strategy for a late-stage small molecule asset as it approaches MAA. You will drive global CMC plans, coordinate with internal stakeholders and manage agency interactions to ensure successful submission and lifecycle management.

The role demands 10+ years in Regulatory Affairs CMC, with strong familiarity with FDA/EMA/ICH frameworks and an ability to navigate cross-functional teams across geographies.