Regulatory Affairs Specialist
4 weeks ago
At MNA Recruitment (Pty) Ltd, we are seeking a highly skilled Regulatory Affairs Pharmacist to join our team. 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:- Manage the registration process for new product submissions, ensuring timely and accurate submissions to regulatory authorities.
- Ensure approval of registration applications for all medicines with relevant authorities, maintaining a high level of compliance and quality.
- Compile and submit dossiers to regulatory authorities, ensuring adherence to regulatory guidelines and standards.
- Collaborate with internal stakeholders to ensure seamless registration processes and maintain effective relationships with regulatory authorities.
- Conduct dossier audits and due diligences, ensuring compliance with regulatory requirements and company objectives.
- Develop and maintain effective relationships with regulatory authorities, ensuring timely and accurate communication.
- 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 in 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 affairs, we encourage you to apply for this exciting opportunity. Please submit your application via this portal or visit our website at www.mnarecruitment.com. We look forward to hearing from you
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