Senior CMC Regulatory Lead for Biopharma Development

GlaxoSmithKline; Durham (NC); On-site; USD 144,000 - 241,000; Full time

Benefits offered by this job

Health care

Retirement benefits

Paid holidays

Vacation leave

Parental leave

Job summary

GSK in the United States seeks a senior CMC regulatory lead to drive global submission strategies for investigational, late development and early commercial products. You will collaborate with chemistry, manufacturing and quality teams to ensure timely and compliant documentation.

You will mentor staff, engage with regulators, and lead major inspections. The role offers broad responsibility within a multinational biopharma environment, with competitive compensation and benefits.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• Four+ years in drug development and manufacturing and supply processes.
• Four+ years interpreting and executing global CMC regulatory requirements.
• Two+ years of project management experience.

Responsibilities

• Lead CMC regulatory strategy for development, registration and lifecycle submissions.
• Coordinate timely preparation and authors of CMC regulatory documents.
• Identify risks and define mitigation strategies for submissions.
• Mentor staff and manage multiple complex projects and teams.
• Engage with internal teams and external agencies on CMC issues.
• Support major inspections and regulatory inquiries.
• Ensure compliance with regional regulatory requirements for trials and releases.

Skills

Communication

Digital Fluency

Influencing

Learning Agility

Regulatory Compliance

Problem Solving

Regulatory Strategy

Strategic Leadership

Education

Bachelor's degree in Life Sciences or related field

Job description

GSK in the United States seeks a senior CMC regulatory lead to drive global submission strategies for investigational, late development and early commercial products. You will collaborate with chemistry, manufacturing and quality teams to ensure timely and compliant documentation.

You will mentor staff, engage with regulators, and lead major inspections. The role offers broad responsibility within a multinational biopharma environment, with competitive compensation and benefits.