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Category: Regulatory
Posted Date: November 19, 2024
GSK is a global biopharmaceutical company with a purpose: to unite science, technology, and talent to get ahead of disease together. We focus on vaccines, specialty medicines, and general medicines, with emphasis on infectious diseases, HIV, respiratory/immunology, and oncology. We are committed to advancing medical discovery and positively impacting the health of billions of people worldwide. At GSK, we foster a culture where people thrive, grow, and contribute meaningfully to our mission.
The Director of Regulatory Affairs CMC will lead strategic CMC regulatory activities for investigational and early commercial biological products. This role is critical in providing regulatory leadership to CMC development teams and the Pharma Supply Chain organization, ensuring the approval and continuous supply of medicines to patients. The Director will work on global regulatory strategies, authoring and preparing CMC regulatory documents, and guiding the business on key strategic initiatives across multiple biopharmaceutical modalities.
Leadership of CMC Regulatory Activities
Strategic Partnership and Collaboration
Regulatory Support for Inspections and Quality Incidents
In-Licensing and Divestment Projects
Problem Solving and Risk Mitigation
Process Improvement and Strategy Execution
We are looking for professionals with the following skills and qualifications:
The following qualifications are a plus:
At GSK, we provide a dynamic and inclusive environment where employees thrive. We offer:
To apply, please submit your CV and cover letter detailing how your experience aligns with the responsibilities and qualifications for this role.
GSK is an Equal Opportunity Employer. We provide equal consideration for employment without discrimination based on neurodiversity, race, color, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, veteran status, or any other protected class.
GSK does not accept referrals from employment agencies for vacancies posted on this site. Agencies must obtain prior written consent from GSK’s HR or Procurement Department before submitting candidates. Without such consent, GSK will not be liable for any fees.
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