Title: Regulatory Affairs Manager
Location: East Rand
Industry: Pharmaceutical
REF: 026

Requirements:

Bachelor of Pharmacy Degree
5 – 7 years’ experience in Regulatory Affairs
At-least 2 years Managerial Experience
Strong understanding of the laws/regulations governing registration of medicines – SADAC countries
Analytical with a high attention to detail
Strong managerial and communication skills
Budget planning experience

Description:

Manager a team of RA Pharmacists and RA Assistants
Ensuring compliance within the RA Department
Responsible for all budgets relating to the department
Compiling/Overseeing submission of dossiers
Delivery of annual product submission plan & new product registrations
Life Cycle Management
Overseeing the various activities performed by the QA pharmacist and overseeing compliance to batch documentation review, annual product reviews, trend analysis and overall quality risk management.
SOP review and approval, creation of new SOPs as and when required
Overseeing the handling of technical product complaints and queries in accordance with the guidelines and requirements.
Training and implementation on new SAHPRA guidelines