Regulatory Affairs & Quality Specialist – Pharma Compliance

Solventum; Sandton; Hybrid; ZAR 750,000 - 900,000; Full time

Benefits offered by this job

Hybrid Eligible

Job summary

Solventum, a healthcare company, is seeking a Regulatory Affairs and Quality Compliance Specialist to manage regulatory projects for South Africa and Sub-Saharan regions. The role ensures ongoing compliance with regulatory and quality systems and reports on adverse events and complaints.

The position requires a Pharmacist registration, Medicines Registration experience, and a strong quality assurance background, with hybrid work options and travel limited to business needs.

Qualifications

• Bachelor’s Degree or higher: Pharmacist.
• Minimum 2 years’ experience in Medicines Registration.
• Minimum 5 years’ experience in Quality Assurance.
• Registered Pharmacist (with SAPC).

Responsibilities

• Deputy Responsible Pharmacist and quality management representative to ensure compliance with local regulatory and quality requirements.
• Manage and oversee all regulatory and quality projects for South Africa and Sub-Saharan countries.
• Secure regulatory licences and certificates.
• Ensure timely regulatory submissions and maintain licences and certificates through annual retention, amendments, rebranding and renewals.
• Monitor regulatory landscape and changes across internal systems and regulatory authority websites.
• Lead regulatory projects to support business opportunities via registration/listing of products.
• Suggest and test ideas on technical and regulatory opportunities.
• Support ISO 13485:2016 certification maintenance.
• Assist external audits and audits of channel partners and third-party distribution centres.
• Ensure timely reporting of complaints and adverse events per procedures and regulatory requirements.
• Support export-model, re-branding, DC separation and spin-off projects.
• Support bids and tenders.

Job description

Solventum, a healthcare company, is seeking a Regulatory Affairs and Quality Compliance Specialist to manage regulatory projects for South Africa and Sub-Saharan regions. The role ensures ongoing compliance with regulatory and quality systems and reports on adverse events and complaints.

The position requires a Pharmacist registration, Medicines Registration experience, and a strong quality assurance background, with hybrid work options and travel limited to business needs.