Regulatory Affairs Manager

6 days ago

Midrand, Gauteng, South Africa Healthcare Businesswomen's Association Full time
Job Summary

We are seeking a highly skilled Regulatory Affairs Manager to join our team at the Healthcare Businesswomen's Association. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and developing strategies to support the registration and maintenance of our products in the East and Southern Africa region.

Key Responsibilities
  • Regulatory Compliance
    • Ensure compliance with regulatory requirements for medicines in the East and Southern Africa/EAC & SADC countries.
    • Monitor and communicate regulatory requirements, intelligence, and policy to facilitate strategic planning for product registration, maintenance of registered base portfolio, clinical trials, policy shaping, capability building, and harmonization initiatives across assigned geographies.
  • Regulatory Strategy Development
    • Support the development and implementation of regulatory strategies for product registration, maintenance of registered base portfolio, and clinical trials.
    • Collaborate with internal stakeholders to ensure alignment with business objectives and develop strategies to address regulatory challenges.
  • Regulatory Database Management
    • Ensure accurate and timely maintenance of RA regulatory databases.
    • Act as a regulatory information management superuser and Single Point of Contact for all Cluster/CO RA compliance activities as assigned by Cluster/CO RA Head.
  • Compliance and Quality Assurance
    • Partner with Global PIE, Sub-Saharan Africa (SSA) Policy & Strategic Operations (P&SO), Cluster/CO RA, Quality Assurance (QA), Patient Safety (PS), to drive the management of RA-related deliverables raised in preparation or during audits and inspections.
    • Support the development of RA-related CAPAs to address audit/inspection findings and follow-up on timely closure of the CAPAs.
  • Post-Approval Commitments and Pharmacovigilance
    • Ensure oversight of post-approval commitments, PV (e.g., PSUR, RMP, safety concerns submissions), and HA approvals, including safety label changes updates and timely completion/response to HA.
    • Ensure oversight of KPI adherence by local representatives/Marketing Authorization Holder (MAH).
  • Communication and Collaboration
    • Communicate timely emerging regulatory requirements and regulatory policy changes to RA colleagues and relevant line functions via written communication such as newsletters, information emails, etc.
    • Establish and maintain strong working relationships with key external stakeholders.
Requirements
  • Functional Breadth
    • Minimum of 1-3 years' experience as RA Manager and managing direct reports.
    • Minimum 3 to 5 years' experience in pharmaceutical regulatory affairs environment.
  • Cross-Cultural Experience
    • Knowledge and experience: Knowledge of Regulatory requirements for Medicines in the East and Southern Africa/EAC & SADC countries.
  • Operations Management and Execution
    • Ability to implement and drive execution.
    • Behaviours: Attention to details, Pro-active, People-orientated, Organizational awareness.
  • Project Management
    • Ability to prioritize workload to tight deadlines.
  • Language Skills
    • English.
Skills
  • Strategic Mindset
    • Strategic thinking, analytical and critical thinking.
  • Regulatory Compliance
    • Regulatory compliance, negotiation skills.

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