Regulatory Affairs Manager- Esa

4 months ago

Midrand, South Africa Novartis Full time

**Summary**:
Support the implementation of regulatory strategies, regulatory specific process/quality standards and all process improvement activities and projects. Ensure process optimization and regulatory compliance for all registered products.
Support in engagement and collaboration with internal stakeholders as well as establishment and maintenance of strong working relationships with key external stakeholders.
To ensure the regulatory databases are up to date and accurate with regulatory relevant parameters on development projects/major line extensions throughout development, registration, and approval including post approval commitments and life cycle maintenance of registered products.
Partnering with Global PIE, Sub-Saharan Africa (SSA) Policy & Strategic Operations (P&SO), Cluster/CO RA, quality Assurance (QA), Patient Safety (PS), in the performance and tracking of on-going regulatory, quality, pharmacovigilance reports (PVR) assessments and rapidly addressing compliance/quality/ PVR & quality management system/training related issue.

**About the Role**:
**Major accountabilities**:

- Support RA Head and managers in elaboration and successful implementation of regulatory strategies for product registration, maintenance of registered base portfolio and clinical trials..
- Support in engagement & collaboration with internal stakeholders as well as establishment and maintenance of strong working relationships with key external stakeholders.
- Support key projects and initiatives e.g. streamlining operations, acceleration of key submission projects and policy initiatives
- Ensuring development and maintenance of dashboards and trackers designed to improve regulatory processes within cluster
- Support internal activities for the development of policy strategies and advocacy plans.
- Ensure compliance to current local regulations: Awareness of current and new local regulations. Communication of any changes that may impact Novartis in a timely manner to all relevant Stakeholders. Partner with relevant stakeholders to ensure timely implementation of new regulations and updating of local working procedures incase needed.
- Ensure adherence to Global and local processes: Align local working procedures with Global processes. Identify gaps in terms of implementation of global procedures and flag gaps to global stakeholder. Provide input to global standard operating procedures (SOPs) under review, if requested. Maintain local working procedures.
- Process improvements: Proactively identify areas of improvement with regards to local compliance and work closely with Cluster/CO RA colleagues and PIE Leads to address them.
- Oversee/Ensure accurate and timely maintenance of RA Regulatory databases: May act as regulatory information managements superuser and Single Point of Contact for all Cluster/CO RA compliance activities as assigned by Cluster/CO RA Head. Ensure correct and timely RA Regulatory database entries e.g., DRAGON, etc.
- Audit/inspections: Work closely with RA Cluster/CO Head, SSA RA P&SO responsible, Patient safety (PS) & quality assurance (QA) 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. Lead Cluster self-assessment and audit readiness.
- Manage deviations and related CAPAs: Oversight of out-of-compliance cases in CPO/cluster, tracking of cases, identification of root causes and solutions. Ensure implementation of corrective action and evaluate effectiveness periodically as required. Collaborates with RA CPO Head, PS and QA to improve efficiency and functionality and maintain Cluster/CPO compliance.
- 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. Also ensure oversight of KPI adherence by local representatives/Marketing Authorization Holder (MAH).
- Ensure timely feedback to compliance related queries/surveys from various stakeholders e.g., from Global PIE, Global labelling, TechOps etc.,
- Ensure issues of non-compliance are handled with urgency and appropriate channels are engaged in a timely manner when necessary.
- Ensure compliance to global and local KPIs.

**Key performance indicators**:

- Recognized by internal and external stakeholders as competent and reliable partner in driving regulatory policy, strategic operations and compliance
- Successful support of implementation of regulatory strategies which result in product registration and clinical trials approvals
- Proactive communication of new and evolving regulatory requirements to relevant stakeholders.
- Successful elaboration and execution of the cluster regulatory Policy strategy as well as Timely and effective coordination and review of draft legislation/ guidelines.
- Successful Creation of required da

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