Regulatory Affairs Scientist

Full Job Description

Regulatory Affairs Scientist

Industry: Pharmaceutical

Location: JHB

Equity Requirement: EE

Large Pharmaceutical Manufacturing facility seeks to employ a Regulatory Affairs Scientist. The following applies:

Key Responsibilities:

• Managing and coordinating the compilation and submission of new product applications.
• Managing and coordinating response to the regulatory authority.
• Maintain regulatory knowledge of the various territories where the registration process is required.
• Effectively managing, auditing and implementation of Regulatory systems

Key Requirements:

• B Sc or equivalent Science degree in a relevant field
• Minimum 1-2 years’ solid experience in Regulatory Affairs, preferably in orthodox, human medicines
• Demonstrable experience across the product development, commercialization, and life-cycle maintenance.
• Knowledge of new and emerging Acts, Regulations and Guidelines pertaining to the pharmaceutical industry.