Global CMC Regulatory Strategy Lead

GSK; Greater London; On-site; GBP 120,000 - 180,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive program

Job summary

GSK is seeking a seasoned regulatory professional to lead global CMC activities across the investigational and early commercial lifecycle. You will drive strategy development for submissions from IND/IMPD through NDA/BLA/MAA, interpreting complex regulations to accelerate approvals while maintaining high compliance with manufacturing and quality standards.

In this role you will collaborate with regulatory, development, quality and manufacturing teams, ensuring timely filings and readiness for

Qualifications

• BSc Life sciences or PhD (or equivalent) with experience in regulatory affairs.
• Strong understanding of worldwide CMC regulatory requirements and submission processes.
• Excellent time management and ability to coordinate multiple tasks under tight deadlines.

Responsibilities

• Manage global CMC regulatory activities for assigned programs across development through early lifecycle/market launches.
• Develop CMC regulatory strategies and ensure submissions (IND/IMPD to NDA/BLA/MAA) meet regional requirements.
• Interpret regulations and advise teams on policies affecting development, registration and manufacturing of medicinal products.
• Ensure CMC aspects for clinical trials and product release comply with timelines and minimize holds.
• Lead cross-functional collaboration with regulatory, development, quality and manufacturing to define filing strategy.
• Drive continuous improvement and share best practices within CMC regulatory teams and related functions.

Skills

CMC regulatory affairs

Regulatory strategy

Cross-functional collaboration

Regulatory submissions

Drug development knowledge

Education

BSc Life sciences or PhD

Job description

GSK is seeking a seasoned regulatory professional to lead global CMC activities across the investigational and early commercial lifecycle. You will drive strategy development for submissions from IND/IMPD through NDA/BLA/MAA, interpreting complex regulations to accelerate approvals while maintaining high compliance with manufacturing and quality standards.

In this role you will collaborate with regulatory, development, quality and manufacturing teams, ensuring timely filings and readiness for