Hybrid Head – Vaccines Development Projects, CMC Regulatory Affairs

Posted 4 weeks ago

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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

Job title

Head – Vaccines Development Projects, CMC Regulatory Affairs

Job type

Experience level

Lead

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

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