Hybrid Director, CMC Regulatory Affairs

at GSK

• Job title: Director, CMC Regulatory Affairs
• Job type: Full Time
• Experience level: Lead
• Salary: $173,250 - $288,750 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, United States

About the role

• Lead global CMC regulatory strategy for complex biological products at GSK. Collaborate across R&D, supply, quality and commercial teams to ensure development and approval.

Responsibilities

• Lead CMC regulatory strategy for investigational and early commercial biological products across global teams.
• Understand, interpret and advise on regulations, guidelines, procedures, policies and strategies relating to development, registration and manufacturing of biological products.
• Serve as a key strategic partner representing Global CMC Regulatory on cross-functional networks and matrix teams.
• Own submission content and ensure regulatory requirements for clinical trials, product release and stability are in place.
• Participate in corporate evaluation and provide CMC regulatory support/advice to in-licensing and divestment projects.
• Identify regulatory risks and propose clear mitigation plans to senior leadership.
• Support major inspections and quality incidents by producing regulatory strategy and managing regulatory interactions.
• Mentor and develop regulatory colleagues, may have direct line management responsibilities as per business needs.
• Has accountability for information submitted in marketing applications to meet regional requirements.

Requirements

• Degree in biological sciences, chemistry, pharmacy, engineering or a related scientific discipline.
• Extensive CMC regulatory experience in biopharmaceuticals, including experience with development and manufacturing requirements.
• Advanced degree (MSc or PhD) in a relevant scientific discipline (preferred).
• Experience leading CMC regulatory teams or line management responsibility (preferred).
• Experience with lifecycle management and post-approval regulatory activities (preferred).
• Experience with cell and gene therapies, therapeutic proteins or other complex biologics (preferred).
• Demonstrated success leading major inspections or regulatory interactions (preferred).
• Practical experience with global regulatory frameworks and agency engagement (preferred).
• Experience with mentoring junior colleagues (preferred).
• Proven track record preparing or contributing to global CMC submissions (preferred).
• Experience engaging with cross-functional teams across R&D, supply and quality (preferred).
• Strong written and verbal communication skills for interacting with internal stakeholders and regulatory authorities (preferred).
• Ability to manage multiple projects, set priorities and meet timelines (preferred).

Benefits

• health care and other insurance benefits (for employee and family)
• retirement benefits
• paid holidays
• vacation
• paid caregiver/parental and medical leave