Deputy Head of Regulatory Affairs

SUMMARY:
A global specialty and branded pharmaceutical company is looking for a Deputy Head of Regulatory Affairs & Deputy Responsible Pharmacist to join their team in Johannesburg North.

POSITION INFO:
OBJECTIVE OF ROLE The Deputy Head of Regulatory Affairs & Deputy Responsible Pharmacist provides operational leadership and functional oversight across Regulatory Affairs (RA-IPDM and RA-SADC) and Pharmacovigilance (PV) to support the Head of Regulatory Affairs in delivering regulatory, safety and commercial objectives for South Africa and the SADC region. The role ensures the effective implementation of the Regulatory Plan, enabling timely marketing authorisations, variation approvals, compliant new product launches, and robust lifecycle maintenance in alignment with business priorities, alliance-partner requirements, and Health Authority expectations. The incumbent oversees and manages day-to-day operations of RA and PV, ensuring robust systems, procedures and governance frameworks that uphold compliance with the Medicines and Related Substances Act 101 of 1965, the Pharmacy Act 53 of 1974, SAHPRA and SADC regulatory frameworks, cGxP standards, and global regulatory and pharmacovigilance obligations. The role provides Regulatory and PV intelligence, risk escalation, audit\/inspection readiness, cross-functional leadership, and regulatory contributions to strategic projects. As a senior leader, the role develops and mentors RA and PV teams, driving operational excellence, cross-functional collaboration, regulatory process optimisation, stakeholder engagement, high-quality reporting and KPI management. When required, the role assumes the delegated statutory duties of the Deputy Responsible Pharmacist, maintaining legal compliance, supporting the Responsible Pharmacist to perform the duties and responsibilities in accordance with provisions of the Pharmacy Act, Act 53 of 1974, as amended and The Medicines and Related Substances Act 101 of 1965, as amended. KEY RESPONSIBILITIES Regulatory Affairs Strategy Management and Planning Responsible for oversight and management of the Regulatory Affairs activities and outputs for medicines in South Africa, SADC region and any other markets active as well as Alliance partner obligations. Pharmacovigilance Responsible for oversight and management of the Pharmacovigilance activities and outputs for medicines in South Africa, SADC region and any other markets active as well as Alliance partner obligations. Quality Management Systems Ensure that the entity's Applicant (MAH) Regulatory and Pharmacovigilance responsibilities regarding products in SA and SADC are fully met through the appropriate utilization of Quality Management Systems (QMS) both internally and externally in compliance with Group policies, procedures and the relevant legislation and guidelines. General Supports and enables service delivery for the RA-IPDM, RA-SADC and PV Departments: Leads and Supports the Management team to ensure values and leadership standards are communicated and understood at all levels within the team Builds trust among team members by setting a highly visible example in terms of professional excellence and commitment to demonstrating values and competencies Drives and supports the establishment of a team culture that values, recognizes and generates high performance, supports innovation and challenges the status quo Supports and encourages knowledge sharing between and \/ or across Regulatory, QA, NPL, NBD, Commercial, Project Management, SA Operations, IT, etc. Evaluate the flow of projects and workload against established timelines and constantly re-evaluate activities and resource-allocation based on changing requirements. Monitor operations to ensure compliance with regulatory requirements Ensure on-going maintenance and enhancements to ensure accurate real time reporting of KPIs Team Management and Leadership Operationalizing the human resources management and adequately implementing the available HR tools Accomplish staff deliverables by communicating job expectations; planning, monitoring, and appraising job outputs; mentoring, coaching, counselling, and disciplining employees; developing, coordinating, and enforcing systems, policies, procedures, and productivity standards Resource needs are reviewed on an ongoing basis. Skills and performance evaluated according to company and departmental needs and policies. Allocating talent and determining position needs in terms of competencies and making the best possible use of existing competencies as a link between individual skills, knowledge and behaviour and the organization's objectives Creating\/maintaining a working atmosphere that stimulates and motivates employees by providing structured communication and information channels and initiating team- oriented activities Training and development identified and implemented within scope of company and department objectives Succession planning and Talent Management Lead, manage, and mentor the Managers and Teams, including reviewing performance against set KPI's Managing workload for optimal performance against set KPIs and timelines Determine priorities and manage resource to ensure the Regulatory Plan is achieved Facilitate regular team meetings to ensure on time delivery Assess training and development needs, prepare, manage, and implement training programs whilst minimizing cost and downtime Promote diversity, equal opportunity and fair treatment Adhere to Company Health & Safety procedures Budget Prepare and maintain budgets for RA-IPDM and PV Departments, ensuring budgets are adhered to, raising any potential deviations to the attention of the Head of Regulatory Affairs as soon as possible Cross Functional Integration support Ensures that the Regulatory Management team aligns with a matrix management approach Communicates company vision and culture Provides input and feedback on optimal service to the business Engages, communicates and collaborates with Senior Leadership Team and business units Negotiate and communicate effectively with all stakeholders Close cooperation with work streams to support cross-functional management, including knowledge sharing Reporting and tracking Ensure the operational activities and requirements of the Regulatory departments are tracked and reported regularly Analysis and reporting of metrics to ensure relevant standards are maintained and objectives are achieved Ensure on time reporting and minutes are available for the Head of Regulatory South Africa Compile periodic progress reports on assigned tasks to provide accurate reporting to Executive management and Third-Party Alliance partners Continuous Improvement & Risk Manage Identify process gaps in Regulatory and PV workflows. Ensure any gaps in processes are identified and closed through cross functional discussions and solutions. Challenge current ways of working with a view to identifying more effective and efficient processes Develop and implement process improvement initiatives Maintain risk registers, anticipate compliance risks, and develop mitigation strategies Electronic Management Systems Ensure that all dossier management and maintenance activities are performed in the required electronic systems Drive the implementation and maintenance of e-systems, ensuring compliance with regulatory and Health Authority requirements EDUCATIONAL REQUIREMENTS Matric (Grade 12) Bachelor of Pharmacy degree (or equivalent) Registration with the South African Pharmacy Council as a practicing Pharmacist KNOWLEDGE & EXPERIENCE REQUIREMENTS 10 years' experience in a Regulatory Affairs environment (Regulatory Affairs and Pharmacovigilance) Managerial experience in the Regulatory Affairs environment Experience within pharmaceutical industry in a production, quality, or clinical environment Project management experience Quality Management Experience preferred Comprehensive understanding of The Medicines and Related Substances Act 101 of 1965 and the Pharmacy Act Good technical knowledge of Regulatory Affairs, Pharmacovigilance and Quality regulations Comprehensive knowledge of SAHPRA and SADC Regulatory and PV Requirements Good understanding of new product launch planning and requirements Existing and well-developed relationships with key stakeholders in SAHPRA and regulatory bodies SOFT SKILLS AND COMPETENCY REQUIREMENTS High level of integrity, ethical values and confidentiality Make good decisions Customer focus \/ service-orientated and outcome based Initiating action, follow up and time management Positive, diligent and hard worker Ability to prioritise and co-ordinate work Self-motivated Quality orientation Stress tolerance and conflict resolution Problem solving, attention to detail and analytical skill Contribute special expertise Ability to decide, action and assess when to execute Methodical planning and implementation skills Advanced communication skills COMPUTER SKILLS REQUIRED Advanced computer literacy on Microsoft Windows Applications Advanced computer literacy Electronic database management skills DRIVERS LICENCE The successful candidate must have a valid driver's license and be able to travel as per the expectations of the role.

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