CMC Regulatory Leader — Biopharma Development Projects

GlaxoSmithKline; Upper Providence (Delaware County); On-site; USD 180,000 - 240,000; Full time

Job summary

GSK seeks a CMC regulatory lead to drive regulatory strategies for investigational, late development and early commercial products. You will coordinate preparation and authorship of technical CMC documents, assess risks, and mentor staff across functions to ensure compliant submissions.

The role requires a Bachelor’s in Life Sciences and 4+ years in global CMC regulatory work, with strong leadership and project management skills.

Qualifications

• Bachelor’s degree in Life Sciences or related field.
• Four or more years of drug development and manufacturing experience.
• Four or more years interpreting worldwide CMC regulatory requirements.
• Two or more years of project management experience.
• Ability to manage multiple projects/teams.
• Track record of effective influencing and negotiating.

Responsibilities

• Lead CMC regulatory activities for investigational, late development and/or early commercial GSK products.
• Coordinate timely preparation and authors of technical (CMC) regulatory documents.
• Identify risks to the business and provide risk mitigation strategies.
• Mentor or train staff; may have direct line management responsibility.
• Manage projects for multiple complex initiatives across teams.
• Provide strategic direction and cross-department data assessment.
• Engage CMC SME activities internally and externally.
• Deliver CMC regulatory strategy to support inspections or quality events.
• Ensure submission content meets regulatory standards.
• Advise on regulations and policies related to development and manufacturing of biopharmaceuticals.
• Ensure clinical trial and product release CMC information is in place.

Education

Bachelor’s degree in Life Sciences or related field

Job description

GSK seeks a CMC regulatory lead to drive regulatory strategies for investigational, late development and early commercial products. You will coordinate preparation and authorship of technical CMC documents, assess risks, and mentor staff across functions to ensure compliant submissions.

The role requires a Bachelor’s in Life Sciences and 4+ years in global CMC regulatory work, with strong leadership and project management skills.