REGULATORY AFFAIRS PHARMACIST
Grade: 13
Division / Department: Quality Management & Scientific Affairs
Position reports to: Regulatory Affairs Specialist
Minimum Requirements
• Bachelor’s Degree in Pharmacy
• Medicines registration and CTD/e-CTD training
• 3 years’ experience in the SA pharmaceutical industry in a manufacturing/quality assurance/regulatory environment.
• MS Office proficiency (Word, Excel, PowerPoint, Outlook)
Additional Requirements
• Regulatory experience and skills in the compilation, preparation, submission and maintenance of dossiers and new drug applications.
• Understanding of a pharmaceutical quality system, cGMP, GPP principles and pharmaceutical legal requirements.
• International regulatory submissions
• Experience in biologicals medicines manufacturing industry.
• e-CTD submissions
Specific Operational Requirements
• The successful candidate will be required to work an 8-hour day between 08h00 to 16h00
• The successful candidate may be required to work overtime to meet the business needs
• Local travel may be required to meet business needs
Key Performance Areas
• National NBI product regulatory submissions and applications
• International NBI product regulatory submissions and registrations
• Regulatory changes with respect to product licensing conditions, standards and compliance
• Regulatory Affairs Administration
• Internal and external networking and support
Competencies
• Technical / Professional knowledge and skills
• Planning and organising
• Attention to detail
• Communication (written and verbal)
• Critical thinking
• Analytical/problem solving skills
• Work standards
• Initiative and self- motivation
• Networking & Liaison
• Inter-personal skills
• Teamwork & Collaboration