CMC Regulatory Lead, Biopharma Development

Women In Bio; Collegeville (PA); On-site; USD 144,000 - 241,000; Full time

Benefits offered by this job

Health insurance

Retirement benefits

Paid holidays

Job summary

GSK is seeking a CMC Regulatory Leader to guide regulatory strategy for investigational, late development and early commercial products. You will shape submission content, coordinate global CMC dossiers, and mentor teams across functions to ensure compliant, timely filings.

Based in the US, you will engage with internal and external stakeholders, oversee risk management and strategy for inspections, and contribute to shaping regulatory policy within a complex global organisation.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• Four or more years of drug development experience.
• Four or more years of experience interpreting and executing complex worldwide CMC regulatory requirements and demonstrated ability to influence the global internal/external regulatory environment.
• Two or more years of experience completing project management tasks.

Responsibilities

• Drives the CMC strategy coordinates the timely preparation and authors, as needed, technical (CMC) regulatory documents to support development/registration/lifecycle maintenance submission content.
• Identifies risks to the business associated with submission data and provides risk mitigation strategies.
• Mentors or trains staff; may have direct line management responsibility; manages project activities for multiple complex projects.
• Engages and may lead CMC Subject Matter Expert activities internally and externally to improve compliance and efficiency.
• Delivers CMC regulatory strategy to support major inspections or quality incidents; ensures submission content adherence to regulations.

Skills

Communication

Digital Fluency

Influencing Without Authority

Learning Agility

Pharmaceutical Regulatory Compliance

Problem Solving

Regulatory Strategies

Strategic Leadership

Education

Bachelor's degree in Life Sciences

Job description

GSK is seeking a CMC Regulatory Leader to guide regulatory strategy for investigational, late development and early commercial products. You will shape submission content, coordinate global CMC dossiers, and mentor teams across functions to ensure compliant, timely filings.

Based in the US, you will engage with internal and external stakeholders, oversee risk management and strategy for inspections, and contribute to shaping regulatory policy within a complex global organisation.