Regulatory Affairs Specialist: SA Pharma Compliance Expert

Placements24; Willows (CA); On-site; USD 36,000 - 54,000; Full time

Job summary

Placements24 is seeking a Regulatory Affairs Specialist for a distinguished pharmaceutical company in Welkom, South Africa. The role focuses on ensuring compliance with SAHPRA and international guidelines, including dossier preparation and submissions throughout the product lifecycle.

You will collaborate with R&D, QA, and Marketing to gather information, monitor regulatory changes, and guide project teams on submissions and labeling changes. A strong background in CTD submissions is required.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or related field.
• Minimum 4 years in pharmaceutical regulatory affairs with SAHPRA knowledge.
• Experience preparing and submitting CTD dossiers.
• Strong attention to detail and communication skills.
• Based in Welkom or able to commute.

Responsibilities

• Prepare, review, and submit regulatory submissions for pharmaceutical products.
• Ensure submissions are accurate, complete, and compliant with guidelines and standards.
• Maintain regulatory databases and filings; keep information current and accessible.
• Monitor regulatory changes and assess impact on products and operations.
• Manage post-approval commitments, including advertising and promotion compliance.
• Liaise with regulatory authorities and facilitate inspections.

Skills

Regulatory affairs

CTD submissions

Dossier preparation

Regulatory intelligence

Cross-functional collaboration

Education

Bachelor's degree in Pharmacy, Chemistry, Life Sciences

Tools

Regulatory databases

Job description

Placements24 is seeking a Regulatory Affairs Specialist for a distinguished pharmaceutical company in Welkom, South Africa. The role focuses on ensuring compliance with SAHPRA and international guidelines, including dossier preparation and submissions throughout the product lifecycle.

You will collaborate with R&D, QA, and Marketing to gather information, monitor regulatory changes, and guide project teams on submissions and labeling changes. A strong background in CTD submissions is required.