Job Description

Well established Pharmaceutical business seeking to appoint a Regulatory Affairs Pharmacist.

Minimum Requirements:

• Bachelorxe2x80x99s 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.
However, please keep a lookout on our website, www.sixsense.co.za for available positions which may be inline with your career aspirations.

Six Sense Consulting