Regulatory Affairs Expert

hace 1 semana


Bogotá, Bogotá D.E., Colombia Msd A tiempo completo
About the Role

As a key member of our team at MSD, you will be responsible for providing centralized oversight of regulatory activities defined by global, regional, and local contracts and arrangements. This role requires minimal guidance from the Director of Business Development Execution.

Key Responsibilities:
  • Centralized oversight of regulatory activities
  • Oversight and maintenance of tools to enable efficient operations for the Global Regulatory Affairs and Clinical Safety (GRACS) Business Development Execution and GRACS Integration teams
  • Point of contact for all alliance management issues, including contractual questions related to ongoing GRACS activities

This role also involves leading execution and support of ancillary agreement activities, such as divestitures and terminations. You will work closely with Corporate Business Development, Research & Development Division Global Alliance Management (MGAM), and GRACS Business Development to comprehend partner agreements and goals.

Requirements

To be successful in this role, you will require a strong understanding of regulatory and clinical processes for pharmaceutical products, vaccines, and/or biologic products. Additionally, you should have working knowledge of regulatory concepts, requirements, and overall product lifecycle processes.



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