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Regulatory Affairs Pharmacist - 2.5 year FTC

5 months ago984 views
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General Details
Advertised By:Agency
Company Name:Executive Placements
Job Type:Full-Time
Description
Minimum Requirements:
  • Bachelors degree in Pharmacy, registered with the South African Pharmacy Council as a Pharmacist
  • Experience in regulatory affairs, in human medicines minimum 3 years of experience.
  • It is a requirement that the individual has RA experience in Southern Africa markets (Botswana, Namibia, Zambia, Zimbabwe, Malawi and Mauritius), including ZA
Key Knowledge and Skills required:
  • Completion of a Medicines Registration Course would be an advantage
  • Experience in registration of products and regulatory knowledge on South Africa, Botswana and Namibia market guidelines.
  • Demonstrate regulatory experience with a pharmaceutical company with proven examples of contribution.
  • Proven ability to manage complex Regulatory issues and consistently deliver to time, cost and quality standards.
  • Regional Regulatory experience including knowledge of NDA, multisource product applications, and product lifecycle management processes.
  • Demonstrate experience of effective delivery in a complex matrix environment.
  • Knowledge of Regional Regulatory environment
  • Technically competent to understand CMC submissions, interpret and communicate requirements, and identify potential risks.
  • Knowledge of drug development, regulations and guidelines
  • Strong leadership qualities, including excellent communication, negotiation, and interpersonal skills
  • Understanding of pharmaceutical industry, clinical trials and pharmacovigilance
  • Knowledge and understanding of quality systems, processes, audit and inspection
  • Ability to influence at all levels in the organization
  • Able to simplify complex ideas and processes
  • Team player
  • Growth focused
  • Analytical thinking
Please note that if you have not received a response within 14 days of submitting your application that your application was unsuccessful.

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Executive Placements
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