Head – Vaccines Development Projects, CMC Regulatory Affairs
GSK
full-time
Posted on:
Location Type: Hybrid
Location: Wavre • 🇧🇪 Belgium
Visit company websiteJob Level
Lead
About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
vaccine developmentCMC regulatory affairsrisk assessmentproduct developmentregulatory agency communicationbudget managementresource managementglobal regulatory requirementsscientific adviceproduct inspections
Soft skills
communication skillsinterpersonal skillsinfluencing skillscollaborationteam managementstrategic thinkingproblem-solvingleadershipadaptabilitystakeholder engagement
Certifications
Bachelor’s degree in life sciencesBachelor’s degree in pharmacy