Associate Specialist Regulatory Affairs (P1)
Merck Sharp & Dohme Corp.
Johannesburg, Gauteng, South Africa
31d ago

Description

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.

The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-

year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

MSD’s Regulatory Affairs division helps bring new medical advancements to the world by facilitating the communications and procedures that allow swift, organized compliance across regulatory agencies.

As a team of energetic, results-driven individuals, we’re a global network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices, and solutions to the world on time, every time.

  • Under supervision of the Country Lead / Associate Director Regulatory Affairs, the incumbent is responsible for providing regulatory administrative support and coordination for the department with maintenance of tracking systems and databases, preparing submissions and renewals and maintenance of local files
  • Contributes in other regulatory tasks, as required.
  • Builds and maintains standard Regulatory Official Files as well as Marketing Authorization filing and approval binders according to local SOPs.
  • Ensures that regulatory databases and systems are kept updated and complete.
  • Participates in establishing and maintaining of relevant Standard Operating Procedures to secure that the current regulations are complied with.
  • Participates in implementation of updated regulatory documentation according to Agency requirements and in-house guidance.
  • Adequately supports other functions as applicable to enable compliance in areas related to the regulatory function
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