Regulatory Affairs Specialist
3 weeks ago
We are seeking a highly skilled Regulatory Affairs Pharmacist to join our team at MNA Recruitment (Pty) Ltd. As a key member of our regulatory team, you will play a crucial role in ensuring compliance with regulatory requirements and providing superior regulatory services to our clients.
Key Responsibilities:- Initiate and manage the registration process for new product submissions, ensuring timely and accurate processing.
- Ensure approval of registration applications with relevant authorities, maintaining high standards of quality and compliance.
- Compile and submit dossiers to regulatory authorities, ensuring adherence to regulatory guidelines and protocols.
- Manage relationships with regulatory authorities, ensuring effective communication and streamlining of applications.
- Conduct dossier audits and due diligences, ensuring compliance with regulatory requirements and company objectives.
- Develop and maintain effective relationships with internal and external stakeholders to achieve regulatory goals.
- Implement and manage regulatory systems, ensuring alignment with company values and objectives.
- Bachelor's degree in Pharmacy and registration with the South African Pharmacy Council.
- 1-2 years of experience in Regulatory Affairs, preferably in orthodox, human medicines.
- Demonstrable experience across product development, commercialization, and life-cycle maintenance.
- Sound project management capabilities and proven ability to deliver quality, time, and cost standards.
- Knowledge of new and emerging Acts, Regulations, and Guidelines pertaining to the pharmaceutical industry.
If you are a motivated and detail-oriented Regulatory Affairs Pharmacist with a passion for compliance and regulatory excellence, we encourage you to apply for this exciting opportunity.
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Regulatory Affairs Specialist
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