Regulatory Affairs Specialist

2 settimane fa


Siena, Toscana, Italia Glaxosmithkline A tempo pieno
Job Summary

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Glaxosmithkline. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements and guidelines for our products. Your expertise in Chemistry, Manufacturing and Controls (CMC) regulatory affairs will be instrumental in preparing and submitting regulatory documents to global health authorities.

Key Responsibilities
  • Develop and implement regulatory strategies to ensure compliance with global regulatory requirements
  • Prepare and submit regulatory documents, including IND/IMPD, NDA/BLA, and MAA
  • Collaborate with cross-functional teams to ensure regulatory compliance throughout the product lifecycle
  • Stay up-to-date with changing regulatory requirements and guidelines

Requirements
  • Master's Degree in Life Sciences or related scientific discipline
  • Regulatory Affairs Certification (RAPS)
  • Experience in CMC regulatory affairs or product development
  • Strong knowledge of worldwide CMC regulatory requirements
  • Excellent communication and project management skills

Why GSK?

GSK is a global biopharma company committed to uniting science, technology, and talent to get ahead of disease together. We offer a dynamic and inclusive work environment where you can grow and develop your career. Join us and be part of a team that is passionate about making a difference in people's lives.



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