Hybrid Head – Vaccines Development Projects, CMC Regulatory Affairs

at GSK

• Job title: Head – Vaccines Development Projects, CMC Regulatory Affairs
• Job type: Full Time
• Experience level: Lead
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Wavre, Belgium

About the role

• Leads vaccine development projects in CMC regulatory affairs to impact global health at GSK. Collaborates with teams to drive strategic decision-making and ensure successful project delivery.

Responsibilities

• Lead and oversee the development and execution of Vaccine CMC Regulatory strategies, ensuring alignment with GSK’s goals and regulatory requirements.
• Establish and direct appropriate agency communications including End of Phase 2, Pre BLA, Scientific advice, and ad-hoc product specific agency dialogue.
• Ensure risk assessments are conducted, and appropriate mitigation and treatment plans are defined for product developments.
• Provide appropriate GSK representation and input to product specific inspections for CMC aspects to secure approvals of new products and ensure continuous improvement.
• Direct global teams providing the primary interface with GSK global development products including in licensed assets.
• Manage direct agency interface for CMC product specific aspects for all GSK development and in-licensed assets.
• Proactively manage budget and resource requirements for the department.
• Liaise with the heads of CMC Regulatory Development Projects across modalities to drive aligned approaches for developments and filings.

Requirements

• Bachelor’s degree in life sciences, pharmacy, or a related field.
• Extensive experience in vaccine physical product development, CMC regulatory affairs, or related areas.
• Extensive expertise of diverse market environments and requirements.
• Proven ability to assimilate new and emerging requirements and establish optimized approach in global context.
• Strong understanding of CMC regulatory requirements and processes for vaccine development.
• Extensive development experience including previous roles within product development, deep expertise and understanding of regulatory agencies worldwide and proven ability to effectively interface and communicate with global regulatory agencies.
• Experience managing teams and budgets effectively.
• Excellent communication and interpersonal skills, with the ability to influence and collaborate across diverse teams.

Benefits

• Health insurance
• Flexible working hours
• Professional development opportunities