Director, Regulatory Operations

1 month ago


Johannesburg, South Africa ICON plc Full time
Job title : Director, Regulatory Operations Job Location : Gauteng, Johannesburg Deadline : December 15, 2024 Quick Recommended Links
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What you will be doing

  • Lead and oversee regulatory operations activities to ensure compliance with applicable regulations and guidelines.
  • Develop strategies for regulatory submissions and approvals, including INDs, NDAs, BLAs, and marketing authorization applications.
  • Collaborate with cross-functional teams to provide regulatory guidance and support throughout the drug development process.
  • Manage regulatory submissions and timelines, ensuring accuracy and completeness of documentation.
  • Stay abreast of evolving regulatory requirements and trends to inform decision-making and strategy development.

Your profile

  • Bachelor's degree in a scientific or related field; advanced degree preferred.
  • 8+ years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.
  • Strong understanding of global regulatory requirements and guidelines.
  • Proven track record of successful regulatory submissions and approvals.
  • Excellent communication and interpersonal skills, with the ability to collaborate effectively across teams and with regulatory agencies.
  • Proven leadership experience

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