Medical: Responsible Pharmacist & Regulatory Affairs / Quality Assurance Pharmacist – Johannesburg



Responsible Pharmacist:


The Responsible Pharmacist is a natural person who is a pharmacist and who shall be responsible to the council for complying with all the provisions of the Pharmacy Act No. 53 of 1974 and other legislation applicable to services which specially pertain to the scope of practice of a pharmacist, and the legislation applicable to the pharmacy which is under his or her personal supervision


Regulatory Affairs:


To ensure company compliance with regulatory requirements relating to the submission and maintenance of medicines in South Africa and other designated territories


Quality Assurance:


To ensure company compliance with sound Quality Assurance principles, good manufacturing practice and regulatory requirements relating to the warehousing / distribution of medicines in South Africa, including the product complaint reporting process, product release, internal and external audits and GMP training




Responsible Pharmacist:


Contemplated in regulation 25 (3) of the Pharmacy Act and the relevant sections of the Medicines Act shall:


Ensure that he or she in fact continuously supervises the Company


Have appropriate qualifications and experience in the services being rendered by the Company


Ensure that persons being employed by the Company and who provide services forming part of the scope of pharmacy practice of a pharmacist are appropriately registered with the Pharmacy Council


Notify the Pharmacy Council immediately upon receiving knowledge that his/her services as responsible pharmacist have been or will be terminated


Take corrective measures in respect of deficiencies with regard to inspection reports of the Pharmacy Council or in terms of the Medicines Act, and in addition to the general responsibilities also


Ensure that unauthorized persons do not obtain access to medicines or scheduled substances or the pharmacy premises outside of normal trading hours


Establish policies and procedures for the employees of the pharmacy with regard to the acts performed and services provided in the pharmacy


Ensure the safe and effective storage and keeping of medicine or scheduled substance in the pharmacy under his or her direct personal supervision


Have the overall responsibility for release of the finished products to the market


Ensure correct and effective record keeping of the purchase, sale, possession, storage, safekeeping and return of medicines or scheduled substances


Initiate and co-ordinate all recall activities which should involve the Quality Assurance Pharmacist


Compile a letter of delegation of authority in his/her absence


Control the manufacturing or distribution of medicines, scheduled substances or medical devices in terms of the provisions of the Medicines Act, 1965


Ensure that there is compliance with Good Pharmacy Practice as published by the Pharmacy Council



Be part if the decision making process affecting the pharmacy business


Ensure that the pharmacy owner complies with all the conditions of – ownership of such pharmacy business – registration of the pharmacy


Ensure that no person is appointed to perform any act falling outside the scope of practice of the category in which such person is registered or which he/she is not authorized to perform in terms of the Pharmacy Act, 1974 (Act 53 of 1974)


Report in writing any non-compliance with the Pharmacy Act to the management of such pharmacy business and furnish Pharmacy Council with a copy thereof


Not introduce or carry out any instruction or order of management with regard to the pharmacy business of the pharmacy owner which could amount to a contravention of legislation applicable to such pharmacy business and be responsible to the Medicines Control Council for compliance with the provisions of the Medicines and Related Substances Act, 1965 (Act 10 of 1965) relating to the sale control of the manufacturing and distribution of medicines, scheduled substance or medical devices


Regulatory Affairs Pharmacist


Regulatory Activities Delivery of annual product submission plan


Compiling/overseeing submission of dossiers according to annual product submission plan to SAHPRA and regional Medicines Regulatory Authorities within SADC


Due diligence on prospective dossiers from India as well as other third parties. Delivery of Future Registrations


Continuous liaison with SAHPRA to ensure new product registrations are received on time to satisfy the requirement of the business


Compile/oversee that recommendations are responded to timeously. Life Cycle Management


To ensure that necessary updates are made to the Registration Dossier according to latest requirements of the MRA, including conversation of dossiers to the ZA-CTD


To ensure timely approvals of post registration amendments to avoid out of stock


To ensure that the MRA is informed of changes to the registration dossier. Printed Packaging Material Review


Review for compliance with the registered dossier and final approval before print (APLSA and third parties). Marketing Material


Provide regulatory support during concept design of all new marketing material

Ensure compliance of all marketing material with the Marketing Code Authority and legislation


Quality Assurance / Compliance:


Overseeing compliance to batch documentation review, annual product reviews, trend analysis and overall quality risk management


Ensuring adherence to SAHPRA and GMP guidelines by all relevant personnel

SOP review and approval, creation of new SOPs as and when required

Vendor inspection audits when required


Overseeing the handling of technical product complaints and queries in accordance with the guidelines and requirements


Providing feedback to the business regarding any quality issues in the Quality Management Review


Training & Support:


Providing training and support to Regulatory Affairs Pharmacist and Assistants

Training and implementation on new SAHPRA guidelines


Training to sales and office personnel on Pharmacovigilance and other relevant subjects when required


Third Party:


Liaising with India on all regulatory and quality assurance activities


Coordinating GMP/GCP inspections of parent company’s manufacturing facilities with inspectors from the various Regulatory Authorities


Controlling correspondence with other pharmaceutical companies and pharmaceutical consultants with regards to regulatory activities


Vendor inspection audits of distributors and laboratories

Finalizing agreements with third party contract laboratories

Customer relationship management with all third parties mentioned above




Collection of adverse drug reactions and reporting it to the global Pharmacovigilance department


Providing Pharmacovigilance training and documenting these training activities

Provide global Pharmacovigilance with sales data and regulatory information on request


Keep abreast with applicable South African laws, rules and regulations and keep global

Pharmacovigilance informed of significant developments relating to Pharmacovigilance


Ensuring “Dear Healthcare Professional” letters are sent out in the event of urgent safety updates


Overseeing that package inserts are updated to reflect the latest updated safety information


Local Manufacturing Technical Responsibilities:


Ensure that CMO remains GMP compliant and complies with all local legislation and requirements as per the product dossiers


Ensure that all batch documentation is reviewed and releases are done appropriately to ensure that safe and quality products are released to the public


To provide technical support to the CMO regarding any queries or concerns related to any of the products







Bachelor of Pharmacy Degree


Basic Competencies & Experience:

(Knowledge, Skills & Attributes)


Computer literacy


Must have a thorough understanding of the laws and regulations governing registration of medicines in the applicable territories


Organisational and managerial skills; problem solving; analytical skills; service orientation; decision making skills; interpersonal skills; report writing skills


Attention to detail; initiative; confidentiality; customer focused; logical thinking; information seeking; sense of urgency


Previous working experience in Production and Quality Assurance is advantageous

5 years’ experience in a Regulatory Affairs department



Should you meet the above requirements, we urge you to please apply by forwarding your CV along with any supporting documents to

Contact will only be made with shortlisted candidates. Should you not hear from us within two weeks, please consider your application unsuccessful



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