Regulatory Compliance Officer

Regulatory Compliance Officer

Job Purpose
 
The Regulatory Affairs Compliance Officer is responsible for the review and approval for all artwork components to ensure compliance to the relevant Acts, regulations and guidelines. and the maintenance of electronic artwork on designated server. This individual will be the designated responsible individuals within the department that maintains the standards when it comes to Artwork and whom will also be the point of contact in terms of Artwork status. This individual will also be responsible for reviewing and approving the signing off Promotional material (SEP and OTC) to ensure compliance to the relevant Acts, regulations and guidelines.
 
You will need to have the following experience:
 
•A minimum of 4-6 years’ experience in the Regulatory Affairs Industry.
•At least 2 years’ experience in Artwork related role
•Proficient knowledge of the Medicines and Related Substances Act No. 101 of 1965 and related SAHPRA regulations/guidelines, GMP/GLP/GCP, EMA.
•Proficient knowledge of the Pharmacy Act No. 53 of 1974, regulations thereto, the guidelines on Good Pharmacy Practice and Code of Conduct of a pharmacist.
•Knowledge of government regulations, policies and procedures and current Good Manufacturing Practices.
•Experience with electronic computer systems and software applications
 
Qualifications:
Bachelor’s degree in Pharmacy