Regulatory Pharmacist with Manufacturing Background

Job Description

Ensure pharmaceutical products comply with regulatory requirements while supporting manufacturing operations. Responsible for product registration, dossier submissions, regulatory communication, and compliance with GMP standards across manufacturing processes.

Requirements

• Bachelor’s degree in Pharmacy (BPharm)
• Registered with South African Pharmacy Council (SAPC)
• 3 to 5 years experience in regulatory affairs
• Experience in pharmaceutical manufacturing environment
• Familiarity with SAHPRA and global regulatory submissions preferred
• Strong knowledge of pharmaceutical regulations and GMP
• Excellent organisational, analytical, written, and verbal communication skills
• Proficient in MS Office and regulatory software
• Ability to manage multiple projects and deadlines
• Flexibility to adapt to regulatory changes
• Commitment to ongoing professional development

Responsibilities

• Prepare, compile, and submit regulatory dossiers for product registrations and variations
• Manage documentation for renewals, amendments, and new applications
• Maintain knowledge of local and international regulatory guidelines
• Respond to regulatory queries and deficiency letters promptly
• Review and approve product labelling, packaging, and promotional materials
• Liaise with health authorities and stakeholders on regulatory matters
• Support manufacturing compliance, including validation, audits, and batch record review
• Assist with GMP audits, technology transfers, and scale-up activities
• Resolve regulatory issues impacting product manufacturing and release