Senior Manager for GSK leading CMC regulatory strategies for vaccines in a cross-functional environment. Ensuring compliance and driving innovation across global regulatory activities.
Responsibilities
Develop and implement CMC regulatory strategies for vaccines, ensuring compliance with global standards.
Prepare and review technical regulatory documents to support submissions and lifecycle management.
Provide regulatory advice to cross-functional teams, including R&D, manufacturing, and quality assurance.
Lead discussions with regulatory authorities and represent the company in external engagements.
Identify risks and propose mitigation strategies to ensure smooth regulatory processes.
Mentor and train team members, fostering a culture of continuous improvement.
Requirements
Bachelor’s degree in life sciences, pharmacy, chemistry, or a related field
Solid and proven experience in CMC regulatory affairs
Strong knowledge of global CMC regulatory requirements and drug development processes
Proven ability to manage multiple projects and meet deadlines
Must be fluent in English (both written and spoken)
Master’s degree or PhD in a relevant scientific discipline (preferred)
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