Applications accepted until:
Regulatory and Clinical Affairs
- Bachelors Degree in a Science discipline or Pharmacy Medicines registration and CTD/e-CTD training
- 5 years in the SA pharmaceutical industry with regulatory experience and skills in the compilation, preparation, submission and maintenance of dossiers and new drug applications.
- International regulatory submissions
- Understanding of a pharmaceutical quality system, cGMP principles and general regulatory requirements.
- MS Office proficiency (Word, Excel, PowerPoint, Outlook)
- New medicines applications.
- 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
- 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