Job Description

The holder of this position is a key member of the local management team and plays a major role in the overall management of South Africa and Hub SSA. In this context he/she is especially responsible for the:

• Lead the team to drive exceptional customer service both internally and externally
• Ensure the regulatory and quality standards are implemented and maintained in line with legal requirements
• Supervise implementation, continuous improvement and monitor the fulfilment of the Q&R targets including the initiated corrective actions
• Provision of support, advice, and trainings to the business organization in the scope of performed function,
• Optimization/standardization, management and digitalization of Q&R

Management and Steering

• Enables organization to harmonize and improve Q&R procedures, processes, infrastructure by the means of coordination, development and implementation of tools and the adaptation of globally provided contents into local business
• Create an efficient and effective management, organizational and operational structure.
• Establish and promote strong working relationships to HQ as well as counterparts and Business Partners in EMEA functions
• Stimulates cooperation and exchange of knowledge and experiences between 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

• Assist with developing and managing project plans from a Q&R perspective

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

Qualifications, experience, know-how and skills critical for success
1) Required training and education:
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• 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 (in years):

• 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 3) Required personal competencies:

• Excellent communication skills with strong intercultural skills and understanding
• Very high social competence paired with persuasiveness and self-confidence, high level of energy and positivity based on a sincere personality
• Excellent leadership skills and management techniques following good leadership principles
• Team Player with a strong drive to create positive work environment, able to motivate and empower employees
• Excellent skills in presentation, facilitation and training, ability to identify and develop talents
• Passion for continuous learning, ability to solid apprehension and fast familiarization with new and complex tasks
• Future-oriented, solution-oriented, proactive and out of the box thinking personality
• Excellent/ strong ability to set priorities and self-manage high volume workload
• Ability to think strategically and take qualitative decisions even under changing conditions or conflicting requirements
• Strong analytical and problem-solving skills with proven ability to organize and analyse data
• Very structured way of working with strong focus on efficient and effective processes even under pressure
• Highly professional attitude characterized by a result, quality, patient and customer oriented working style
• Hight level of change, negotiation and conflict management skills

4) Other specialized knowledge, expertise and skills:

• Knowledge on dialysis and further medical and pharmaceutical products and services of both FME and competitors as an advantage
• Knowledge of current legislation governing product quality and product registration (Medical Devices and Medicinal Products) in the SSA region
• Knowledge of other legal requirements impacting the regulatory/quality environment i.e. advertising, trade and metrology, GMP, GLP, GCP, GDP, GVP, ISO 13485, ISO 9001, etc.
• Knowledge about all applicable laws regarding manufacturing, testing, distribution or advertising of Medicinal Products and Medical Devices
• Knowledge of pharmacology and therapeutics
• Knowledge of operations i.e. quality assurance, quality control and manufacturing

b) IT skills

• Understand and use modern communication software and systems
• Strong IT user knowledge (MS Office, SAP, Intranet etc.)
• Understand basics of e-health, data security and related topics
• Up-to-date knowledge of IT and digitalization

c) Languages
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• Country language and English fluent as a must (presenting, writing, reading)
• Other languages besides country language an asset

5 ) Special personal requirements:

• Working for an international company with international standards
• Travelling within the region and international across different time zones

Skills Required