Pharmaceutical Regulatory Specialist
2 days ago
At Emporium, we are seeking a highly skilled Pharmaceutical Regulatory Specialist to join our team.
As a key member of our regulatory affairs department, you will play a vital role in ensuring that all promotional material and packaging is legally compliant with relevant statutory laws, regulations, rules, and standards.
Key Responsibilities:- Compliance Management: Ensure that all promotional material and packaging meets the required legal standards, including SAHPRA Regulations Act 101 of 1965; Foodstuff, Cosmetics and Disinfectants Act 54 of 1972, and Trade and Metrology Act.
- Artwork Approval: Approve all artwork pieces in compliance with specified guidelines, requiring a sound knowledge of both English and Afrikaans languages.
- Regulatory Framework Compliance: Ensure corrective action for meetings, events, and other activities aligns with the applicable regulatory framework.
- Sample Management: Ensure that all samples requested are appropriately approved and documented according to the regulatory framework.
- Complaint Resolution: Timely and efficiently handle and resolve all complaints related to the above-mentioned functions.
- Quality Control: Review and approve SOPs for the Compliance department, establish the need for additional controls or processes for effective quality control, and provide training on the Marketing Code of practice.
- Data Analysis: Compile statistics and reports on a monthly basis to the Head of Quality, Compliance, and RA.
- Risk Assessment and CAPA: Ensure Risk Assessments are performed and Self Inspections are conducted with CAPAs identified.
About You:
- Qualifications: Bachelor of Pharmacy with registration with the South African Pharmacy Council.
- Experience: Prior experience in the pharmaceutical industry in the Regulatory or related environment, with at least two years working experience in the field of artwork and promotional material.
- Language Skills: Sound knowledge of both English and Afrikaans languages.
Contact Information: Please forward CVs to [no contact information provided] using RA Pharma or POS25052 as reference.
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