Description:
Minimum requirements for the role:A Bachelor of Pharmacy degree and registered with the South African Pharmacy Council is essential.
Previous experience having worked in a Regulatory Affairs role within the Pharmaceutical Industry is essential.
Previous experience having worked within a QA/QC management role would be preferred for the role.
The successful candidate must have the ability to manage priorities, work on multiple matters at once, meet deadlines and have good communication skills.
The successful candidate will be responsible for:
Ensuring high standards of pharmaceutical care in accordance with good practice and other legal requirements.
Ensuring compliance with the legislative requirements as set out in the Medicines and Related Substances Act 101 of 1965 and Pharmacy Act 53 of 1974 as well as all applicable legislative requirements for the Companys product portfolio and all regulations and guidelines pertaining to the import and export license for medicinal products and good manufacturing practices.
Ensuring compliance with statutory and regulatory requirements of the various authorities in South Africa and related authorities in other African countries where products are sold.
Providing regulatory intelligence and advice to the business divisions with regards to regulatory changes affecting the importation and exportation of the products.
Responding to requests adequately, satisfactorily and timeously for external customers.
Managing compilation of dossiers and technical files for registration applications of new products in South Africa and related authorities in other African countries.
Maintaining existing dossiers and technical files, as per global and local health authority requirements.
Submitting and following-up on all product registration amendments.
Managing the quality control system.
Liaising with the source of supply on all quality related issues.
Compiling all release documentation as well as the release of all products.
Investigating and reporting on customer complaints as per local and Company requirements.
Investigating and reporting on defective or rejected products.
Performing all daily activities in line with the Companys policies and code of conduct, integrity and compliance.
Salary package, including benefits, is highly negotiable depending on experience gained.
13 May 2022;
from:
gumtree.co.za