Regulatory Compliance Pharmacist

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

To ensure compliance with regulatory requirements, GMP, and standards. Provide regulatory support for lifecycle management, change control, submissions, and dossier maintenance , To support the compilation and review of quality and regulatory documentation for regulatory submissions. Ensure the effective quality and regulatory change management for products manufactured by facilities contracted by Aspen SA Operations and for products in which Aspen SA Operations is the MAH.

• Oversight of manufacturing activities to ensure ongoing compliance with regulatory requirements, GMP standards, and associated procedures.
• Manage and assess quality and regulatory change controls, including impact assessments, implementation planning, and oversight of changes across internal and third-party manufacturing sites.
• Compile, review, maintain, and control regulatory documentation to support product registrations, variations, renewals, and lifecycle management activities.
• Provide regulatory intelligence and guidance pertaining to product registrations and variations.
• Maintain and oversee the control of the product dossier IP where Aspen SA Operations is the MAH
• Drive continuous improvement projects to improve efficient and compliance
• Prepare and adhere to relevant process flows and SOPS where applicable.
• Compile datapacks for new product introduction projects or variations where applicable.
• Request legalised documents and CPPs where applicable
• Maintain regulatory trackers and spreadsheets.

Qualification:

• Grade 12/Matric & Degree in Pharmacy (Post-Graduate qualification is advantageous)

Experience:

• 5 - 8 Years’ sterile/ solids pharmaceutical manufacturing experience, and or Quality Assurance experience
• Regulatory and quality and compliance experience
• Strong technical and scientific writing and investigation skills
• Knowledge of regulatory affairs and product dossiers, pharmaceutical standards and compliance