CMC Regulatory Strategy Lead – Biopharma Development

GlaxoSmithKline; Waltham (MA); Hybrid; USD 144,000 - 241,000; Full time

Benefits offered by this job

Annual bonus

Health insurance

Retirement benefits

Paid holidays

Parental and caregiver leave

Job summary

GSK is seeking a CMC Regulatory Lead to drive regulatory strategy across development to early commercial products. You will coordinate cross-functionally to prepare, review, and submit CMC content, while assessing risks and implementing mitigation plans.

You may mentor teams and collaborate with internal/external partners to align regulatory expectations. The role requires extensive experience with global CMC regulations, strong leadership, and a track record of influencing regulators.

Qualifications

• Bachelor's degree in Life Sciences or related field.

Responsibilities

• Leads CMC regulatory activities for investigational, late development and/or early commercial products.
• Manages risks to submissions and communicates mitigation strategies.
• Mentors staff and may have line management responsibilities for complex projects.
• Engages in CMC SME activities internally and externally to harmonize and improve regulatory processes.
• Delivers CMC regulatory strategy to support inspections and quality incidents.
• Ensures submission content adheres to regional requirements for clinical trials and product release.

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

Four or more years of experience in drug development and manufacturing and supply processes

Four or more years of experience interpreting and executing complex worldwide CMC regulatory requirements

Two or more years of experience completing project management tasks

Job description

GSK is seeking a CMC Regulatory Lead to drive regulatory strategy across development to early commercial products. You will coordinate cross-functionally to prepare, review, and submit CMC content, while assessing risks and implementing mitigation plans.

You may mentor teams and collaborate with internal/external partners to align regulatory expectations. The role requires extensive experience with global CMC regulations, strong leadership, and a track record of influencing regulators.