Global CMC Regulatory Strategy Manager

GlaxoSmithKline; Newtonville (NY); On-site; USD 140,000 - 190,000; Full time

Job summary

GlaxoSmithKline is seeking a CMC Regulatory lead to manage global regulatory activities for investigational and lifecycle management of products. You will shape CMC strategy and coordinate submissions from early clinical stages through to marketing applications, working with regulatory, development, quality and manufacturing teams.

The role requires experience in global CMC regulatory affairs and a track record of delivering compliant dossiers across development stages.

Qualifications

• Broad knowledge of drug development and CMC processes.
• Experience delivering regulatory submissions (IND/IMPD, NDA/BLA/MAA).
• Ability to interpret global CMC requirements and advise teams.
• Strong project management and cross-functional collaboration skills.

Responsibilities

• Lead global CMC regulatory activities for assigned projects.
• Develop CMC strategy for submissions from IND/IMPD to NDA/BLA/MAA and early lifecycle activities.
• Interpret regulations and advise teams to expedite submissions and approvals.
• Ensure CMC regulatory compliance for clinical trials and product releases.
• Collaborate in cross-functional teams with regulatory, development, quality and manufacturing.

Skills

Communication

Regulatory strategy

Influencing without authority

Problem solving

Education

BSc Life sciences or related discipline

PhD

Job description

GlaxoSmithKline is seeking a CMC Regulatory lead to manage global regulatory activities for investigational and lifecycle management of products. You will shape CMC strategy and coordinate submissions from early clinical stages through to marketing applications, working with regulatory, development, quality and manufacturing teams.

The role requires experience in global CMC regulatory affairs and a track record of delivering compliant dossiers across development stages.