Well established Pharmaceutical business seeking to appoint a Regulatory Affairs Pharmacist in a 2.5 year FTC
Minimum Requirements:
Bachelor's 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.
However, please keep a lookout on our website, www.sixsense.co.za for available positions which may be inline with your career aspirations.
For more information please contact:
Audra King
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