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Regulatory Affairs Specialist in Pharmaceutical Industry
2 weeks ago
At MVG Recruitment Specialists, we are seeking a highly skilled Regulatory Affairs Specialist to join our team in Johannesburg. As a Regulatory Affairs Specialist, you will be responsible for managing and coordinating the compilation and submission of new product applications.
The ideal candidate will have a strong understanding of regulatory requirements and experience in managing multiple projects simultaneously.
We offer a competitive salary package and a dynamic work environment.
Key Responsibilities:
- Managing and coordinating the compilation and submission of new product applications.
- Managing and coordinating response to the regulatory authority.
- Maintaining regulatory knowledge of various territories where registration is required.
- Effectively managing, auditing, and implementing regulatory systems.
Required Skills and Qualifications:
- Bachelor's degree in a relevant field such as science or pharmacy.
- Minimum 1-2 years' solid experience in Regulatory Affairs, preferably in orthodox, human medicines.
- Demonstrable experience across 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.