Regulatory Affairs Pharmacist with Brand Manager Experience
Aeroton
R 900k per annum
Job Purpose :
- To consider, examine, correct and approve all printed packaging and promotional material and advertisements, meetings, events and other interactions with healthcare professionals, ensuring they are legally compliant with statutory laws, regulations, rules, and standards (as per the King Code of Governance South Africa).
Requirements :
- Bachelor of Pharmacy with registration with the South African Pharmacy Council
- Experience in generic product marketing
- Prior experience in the pharmaceutical industry in regulatory affairs or a related environment
- At least two years of experience working with artwork and promotional materials
Duties :
- Ensure all promotional material and packaging comply with relevant statutory laws, regulations, rules, and standards.
- Approve all artwork in accordance with specified guidelines, requiring proficiency in both English and Afrikaans. Comply with SAHPRA Regulations Act 101 of 1965, Foodstuff, Cosmetics and Disinfectants Act 54 of 1972, and Trade and Metrology Act.
- Implement corrective actions for meetings, events, and activities in line with the regulatory framework.
- Approve and document all requested samples according to regulatory requirements.
- Handle and resolve complaints related to the above functions promptly and effectively.
- Review and approve SOPs for the Compliance department; establish additional controls or processes for quality assurance.
- Train relevant staff on the Marketing Code of Practice and ensure MCA certification is obtained.
- Prepare monthly statistics and reports for the Head of Quality, Compliance, and RA.
- Perform risk assessments and conduct self-inspections, identifying CAPAs as needed.
- Maintain and update databases to reflect current approved information.
- Implement future regulatory changes at the operational level.