Regulatory Affairs Expert

1 week ago


Johannesburg, Gauteng, South Africa Genpact Full time

Job Summary

About the Role

We are seeking a highly experienced Regulatory Affairs professional to join our team as a Pharmaceutical Products Manager in Africa.

Key Responsibilities
  1. Lead all local regulatory affairs lifecycle management (LCM) and maintenance activities for assigned products, including variations, renewal, and PSUR submission strategy.
  2. Develop and implement RA assessment through change management system, CMC assessment, timelines, and handling of deficiency letters.
  3. Manage local RA requirements, including implementation tasks, artwork changes, and coordination with different groups.
  4. Update Local PI and ensure customer success throughout the engagement.
Requirements
  1. Bachelor's degree in Pharmacy, Medicine, Chemistry, or related Life science discipline, with relevant experience in the pharmaceutical industry.
  2. Mandatory knowledge of EMEA/South Africa regulation and adherence to the English language.
  3. Registered pharmacist in South Africa.
  4. Effective time management and organizational skills to efficiently manage multiple time-sensitive assignments simultaneously.
  5. Demonstrates deep understanding of business value of quality and compliance, and implications and risks of non-compliance.


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