POSITION : REGULATORY AFFAIRS PHARMACIST
DIVISION : PHARMA - ISANDO

JOB OBJECTIVE
• Registration of new products in SA & international markets
• Maintenance of existing registrations at health authorities in countries where the company is active
• Compliance with health authority requirements
• Communication with applicable health authorities
• Communication with applicable county agents
• Pharmacovigilance
• Training

TASK DESCRIPTION
• Receipt, screening, compilation and timeous submission of applications for registration to the relevant regulatory authority.
• Receipt, preparation and submission of all applicable updates, amendments, resolutions and any other correspondence required by the applicable regulatory authority
• Communication with the relevant regulatory authority
• Communication with the relevant country agent
• Communication with the sales and marketing team
• Review and approval of change requests and deviations related to regulatory matters
• Checking promotional material (including MIMS) for compliance with HA guidelines and marketing code authority and/or advertising standards authority guidelines
• Compilation and update of package inserts and patient information leaflets
• Creating presentations where necessary for training purposes
• Back-up for pharmacovigilance

EDUCATION AND KEY EXPERIENCE
• B.Pharm Degree
• Minimum 3 years’ experience in regulatory affairs, ideally within an manufacturing environment
• MS Office basic training
• Quality Assurance and Export regulatory affairs experience will be an added advantage

Should you not receive any correspondence within two weeks of submitting your application, please
Consider your application unsuccessful.

CLOSING DATE: FRIDAY, 27 JULY 2018