Regulatory Affairs Scientist Johannesburg

Regulatory Affairs Scientist

Large Pharmaceutical Manufacturing facility seeks to employ a Regulatory Affairs Scientist.

Key Responsibilities:

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

Key Requirements:

1. BSc or equivalent Science degree in a relevant field.
2. Minimum 1-2 years' solid experience in Regulatory Affairs, preferably in orthodox, human medicines.
3. Demonstrable experience across the product development, commercialization, and life-cycle maintenance.
4. Knowledge of new and emerging Acts, Regulations and Guidelines pertaining to the pharmaceutical industry.
5. Sound project management skills.
6. Strategic thinking and planning.
7. Ability to handle multiple projects simultaneously.
8. Cross Functional capability.

Full role profile available on application.