Regulatory Affairs Scientist
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:
- BSc 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.
- Sound project management skills.
- Strategic thinking and planning.
- Ability to handle multiple projects simultaneously.
- Cross Functional capability.
(Full role profile available on application)
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