Global Vaccines CMC Regs Lead — Strategy & Submissions

CamWebDir; United Kingdom; Hybrid; GBP 108,000 - 169,000; Full time

Job summary

Merck & Co., Inc. seeks a Regulatory Affairs leader to develop and implement CMC regulatory strategies for global products.

You will lead the development, authoring and review of submission components to support approvals and variations, liaise with global teams and external partners, and drive milestones across the lifecycle. The role requires strong communication, cross-cultural collaboration, and expertise in eCTD, BLA and regulatory writing; a hybrid work model is available with a

Qualifications

• Bachelor's degree in science, engineering or related field; advanced degree preferred but not required.
• At least 5 years pharmaceutical regulatory experience or up to 3 years managing CMC submissions for small molecules, vaccines, or biologics.
• Experience with Veeva and electronic submission standards (eCTD).

Responsibilities

• Lead global regulatory strategies by identifying requirements and evaluating documentation for acceptability and risk.
• Develop and review CMC submissions and documentation to support variances, supplements and regulatory filings.
• Coordinate with manufacturing, CMOs, and external partners to ensure compliant change management.
• Assess regulatory risks and communicate mitigation strategies.
• Deliver regulatory milestones across product lifecycles.

Skills

Regulatory strategy development

eCTD

Regulatory submissions

BLA

Veeva

Cross-cultural awareness

Technical writing

Regulatory affairs management

Education

Bachelor's in science/engineering or related field

Tools

Veeva

Job description

Merck & Co., Inc. seeks a Regulatory Affairs leader to develop and implement CMC regulatory strategies for global products.

You will lead the development, authoring and review of submission components to support approvals and variations, liaise with global teams and external partners, and drive milestones across the lifecycle. The role requires strong communication, cross-cultural collaboration, and expertise in eCTD, BLA and regulatory writing; a hybrid work model is available with a