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  • 3 weeks ago

jobs description

Reference: SSC000560-AK-2Well established pharmacuetical business seeking to appoint Senior Regulatory Affairs Pharmacist.

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.
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 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

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.
Boksburg South Africa


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