Job Description

Management and Steering

Enables organization to harmonize and improve Q&R procedures, processes,

infrastructure by the means of coordination, development and implementa


tion of tools and the adaptation of globally provided contents into local


business

Create an efficient and effective management, organizational and opera

tional structure.

Establish and promote strong working relationships to HQ as well as coun

terparts and Business Partners in EMEA functions

Stimulates cooperation and exchange of knowledge and experiences be

tween all organizational units (from driving innovations)


Operations

Regulatory Registration Management

Oversee the evaluation of the registration packages received from Principals. Identify and negotiate to obtain data identified as required in due diligence reports for registration of Medicinal Products and Medical Devices. Develop strategies which assist in negotiations with the Health Authorities to obtain registration approvals of Medicinal Products and Medical Devices for Regional Hub SSA business. Oversee the preparation and ensure the submission of new regulated product applications and registration by or before the target dates as well as the timeous submission of responses to deficiency letters received from the MOH's. Prepare and/or manage the submission of appeals in response to negative decisions received from SAHPRA committees and other health authorities in SSA countries. Establish realistic timelines for the registration of products and effectively bring the Regional Hub SAA with the local regulatory backlog up to date.

Regulatory Responsibilities

Ensure compliance to any applicable national requirements for the distribution of Medicinal Products and Medical Devices in the respective markets Establish and maintain a management system according to the national requirements Identify and implement effective processes and procedures for accomplishing compliance to documented CAPA's. Plan, manage and control the day-to-day execution of regulatory affairs activities and drive improvement Maintain adequate records of registration activities and track registration submissions and approvals Keep up to date with respect to new legislation in countries of responsibility and advise the company on the impact of new legislation on current business. Develop strategies and systems to remain compliant locally and that are in line with Region requirements Establish and maintain relationships with the MOH's, distributors, and key role players in the industry. Establish regulatory compliance regarding the sale of non-registered medicines - approved as Section 21 drugs

Sales and Marketing Support

Establish regulatory compliance regarding the sale of non-registered medicines - approved as Section 21 drugs

Vigilance Management

Ensure the processing of all quality related product complaints, including traceability and CAPA logging. Implementation of MD vigilance and PV System (Responsibilities, Processes, CAPA`s, Training) in the respective area Ensure compliance with FMC`s MD and PV Processes Ensure that local ADR's are reported as local legislation stipulates and inform Pharmacovigilance Corporate Drug Office. Ensure all learning requirement modules are actioned for the Regional Hub SSA personnel as well as AR's for Export countries. Ensure around the clock monitoring and availability of dedicated identified reporting channels Ensure a functional recall system

Management of the Quality Assurance (QA) functions

Qualification of contract manufactures, critical suppliers or service providers Creation and maintenance of Quality Assurance Agreements (QAA) with contract manufacturer, critical suppliers or service providers Implementation of QAA & PVA with all TPIs (Distributors) in the SSA Region, when applicable Creation and maintenance of supplier evaluation Ensure the activities are in compliance to the QAAs entered into the Regional Hub SSA Oversee QA functions are conducted compliantly to company policies and procedures and government regulations Performance, administration and documentation of annual self-inspections Performance of mock recalls Ensure the activities are in compliance to the Technical Agreements entered into the Regional Hub SSA. Ensure the compilation and implementation of documents required in order to remain compliant with the local regulators as per the local published and current acts and regulations, for the business continuity of Pharmaceutical and Medical device products. Packaging compliance and transition in the requirements to remain compliant to the region and practical for local system requirements and legislation Leading external and internal audits by ensuring that all required documentation is available and involved personnel are well prepared. Establishing the required CAPAs and ensuring that all actions are completed in compliance with established deadlines.

Responsible Pharmacist responsibility

Serves as responsible pharmacist in terms of the Medicines & Related Substances Act 101 of 1965 as well as Pharmacy Act 53 of 1974 Testing and release of Medicinal Products to bring into the market. Documentation Control Management Be familiar with the Global Management System, Internal company generated policies and procedures, in particular those pertaining to QA, Regulatory Affairs, Environmental, Pharmacovigilance and Compliance. Oversee the co-ordination and compliance to GDP within the QMS of the Regional Hub SSA Oversee the initiating, updating and maintenance of the company's Documentation Control System.

Quality, Legal & Compliance

Follow and comply with all relevant FME policies, guidelines, manuals and SOPs in the version as amended from time to time ("FME Policies") Keep yourself updated about the current version of the FME Policies that are relevant for your role and integrate corporate values in daily business

1) Required training and education:

Pharmacy Honours Degree Functional related post graduate education (PhD, MBA) is a benefit Valid registration as a practising pharmacist with the SAPC Tertiary courses in Medicine Registration, Advertising Medicines, Quality Management system, Good Manufacturing Practices, Pharmacovigilance, and other related subjects Qualification in Medical Device and EHS Regulations preferred but not essential

2) Required professional experience :

A minimum of 5 years of professional practice as a pharmacist Work experience in Quality and Regulatory affairs (> 5 years) * Strong and successful performance in an executive management role (> 5 years professional experience) in a healthcare or healthcare-related business environment, ideally in an international company