Head of Regulatory Affairs

3 weeks ago

Johannesburg, South Africa Acino Full time

Acino values courage, commitment, trust, and empathy and provides an environment that supports initiative and effort. With our ‘hands-on’ mentality, short communication channels and quick decision-making we deliver sustainable results for our customers, partners and employees. With passion, commitment and dedication, the role you start with at Acino will evolve and change to so much greater.
Join one of the world’s fastest growing pharmaceutical companies and be part of our growth story.

**Job Purpose**: To describe the role and responsibilities of the Responsible Pharmacist as contemplated in regulation 25 (3) of the Pharmacy Act and the relevant sections of the Medicines Act (Act 101 of 1965) and the South African Guide to Good Manufacturing Practices.

**Main Duties and Responsibilities are**:

- Responsible Pharmacist Duties: _
- Responsible for the continuous supervision of the actions and activities of the pharmacy to ensure on-going compliance to relevant Acts, Regulations, Guidelines and Codes.
- Responsible to ensure that pharmacists who provide services forming part of the scope of pharmacy practice are appropriately registered with the Pharmacy Council.
- Responsible to ensure that defined roles and responsibilities for personnel exists and that training programs are implemented and maintained, that personnel are trained in cGMP and that continuous training is in place.
- Responsible to ensure the company is in possession of the required License/s from SAHPRA to conduct its business.
- Responsible for the registration of medicines with the South African Health Products Regulatory Authority and the maintenance of these registrations.
- Responsible and accountable to the South African Health Products Regulatory Authority and the South African Pharmacy Council for compliance with the provisions of the Medicines and Related Substances Act, 1965 (Act 101 of 1965) and its Amendments relating to the sale, control of the manufacturing and distribution of medicines, scheduled substances, or medical devices.
- Responsible for notifying the SA Pharmacy Council immediately upon receiving knowledge that his/her services as Responsible Pharmacist have been or will be terminated.
- Responsible for taking corrective measures in respect of deficiencies regarding inspection reports of the SAPC or SAHPRA.
- Responsible to ensure that a Pharmaceutical Quality Management System is in place. Delegated activity.
- Responsible for initiating and coordinating all recall activities, including involving the head of Quality Management.
- Responsible to ensure that a letter of authorization to communicate with SAHPRA, signed by the CEO, is submitted to SAHPRA.
- Responsible for the compilation of a letter of delegation of authority in his/her absence.
- Responsible for compliance with Good Pharmacy Practice as published by the SA Pharmacy Council.
- Responsible for participating in decision-making processes affecting the pharmacy business.
- Responsible to supervise every pharmacist appointed by the owner of the pharmacy business.
- Responsible for compliance by the pharmacy owner with all the conditions of ownership of the pharmacy business and registration of the pharmacy.
- Responsible to 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).
- Responsible to report in writing, any non-compliance with the Pharmacy Act to the management of such pharmacy business and to furnish the SA Pharmacy Council with a copy thereof.
- Responsible to ensure that no instruction or order of management with regard to the pharmacy business that could amount to a contravention of legislation applicable to the pharmacy business, is introduced or carried out.
- Accountable for the release for sale of finished product. This release should include the completion of a check list which will ensure that all important release criteria have been met. Delegated activity.
- Completion of all individual assigned training within the specified timelines.
- Forwarding of all received Product Quality Complaints, Adverse Events and Medical Enquiries to the relevant person in Quality Assurance/ Pharmacovigilance/ Medical Affairs.
- Ensure the availability of training plans according to the direct report’ s role profiles within the team.
- Ensure that the relevant training has been completed according to the training plan.
- Head of Regulatory Affairs Duties: _
- Ensuring alignment of global and regional commercial strategic plan with the Regulatory affairs submission plans for ESA markets.
- Preparation of the ESA RA budget and tracking actual vs projected spend.
- Identification of key RA projects and facilitating the implementation thereof
- Mentorship of the Senior RA Managers with the intention of succession planning.
- Form part of the regional executive commit

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