Senior Regulatory Affairs Pharmacist - Johannesburg, South Africa - Six Sense

Six Sense
Six Sense
Verified Company
Johannesburg, South Africa

1 week ago

Thabo Mthembu

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Thabo Mthembu

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Description
Gauteng, JHB - Eastern Suburbs

  • Annually Cost To Company (Market related)
Well established pharmacuetical business seeking to appoint Senior Regulatory Affairs Pharmacist.


SKILLS & QUALIFICATIONS:


  • Bachelor's degree in Pharmacy, registered with the South African Pharmacy Council
  • MSc, MBA or PhD may be an advantage.
  • Experience in regulatory affairs, preferably in human medicines minimum 8 years of experience.

Key Knowledge and Skills required:


  • 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.
  • 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 and management 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
  • For more information please contact:
  • Audra King
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