Regulatory Compliance Pharmacist — GMP & Submissions Lead

Aspen Pharma Group; Gqeberha; On-site; ZAR 600,000 - 900,000; Full time

Job summary

Aspen Pharma Group in South Africa seeks an experienced Regulatory Affairs professional to provide lifecycle management, change control, submissions and dossier maintenance for products manufactured by Aspen SA Operations. The role ensures compliance with GMP standards and oversees regulatory documentation across internal and third-party sites.

The incumbent will drive continuous improvement in regulatory processes and maintain IP dossiers where applicable.

Qualifications

• 5-8 years' sterile/ solids pharmaceutical manufacturing experience or QA experience.
• Strong regulatory and quality compliance knowledge.
• Excellent technical and scientific writing and investigation skills.
• Familiarity with regulatory affairs, dossiers, and pharmaceutical standards.

Responsibilities

• Provide regulatory support for lifecycle management, change control, submissions, and dossier maintenance.
• Oversee compilation, review and control of regulatory documents for product registrations, variations, renewals, and lifecycle activities.
• Provide regulatory intelligence and guidance on product registrations and variations.

Skills

Regulatory affairs

GMP compliance

Change control

Technical writing

Investigations

Regulatory dossiers

Education

Bachelor's degree in Pharmacy

Job description

Aspen Pharma Group in South Africa seeks an experienced Regulatory Affairs professional to provide lifecycle management, change control, submissions and dossier maintenance for products manufactured by Aspen SA Operations. The role ensures compliance with GMP standards and oversees regulatory documentation across internal and third-party sites.

The incumbent will drive continuous improvement in regulatory processes and maintain IP dossiers where applicable.