Regulatory Affairs Pharmacist - 036/2018
Code/Reference:
036/2018
Applications accepted until:
2018-11-29
Number of Openings
1

Employment Type

Full Time

Department

Regulatory and Clinical Affairs

Minimum Requirements

  • Bachelor€™s Degree in Pharmacy
  • Medicines registration and CTD/e-CTD training
  • 2 years€™ experience in the SA pharmaceutical industry in a manufacturing/quality assurance/regulatory environment.
  • Understanding of a pharmaceutical quality system, cGMP, GPP principles and pharmaceutical legal requirements.
  • 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