Regulatory Affairs Pharmacist

Johannesburg, Gauteng, South Africa

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Minimum Requirements:

Bachelors 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 5 years of experience.
Experience in registration of products and regulatory knowledge on South Africa, Botswana, Namibia, Mauritius, Zambia, Zimbabwe and Malawi market guidelines.

Key Knowledge and Skills required:

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, biosimilar submission processes and product lifecycle management processes.
Demonstrate experience of effective delivery in a complex matrix environment.
Knowledge of Regional and Global 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
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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