Job Description 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.
Job Description 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.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. Communicate timely emerging regulatory requirements and regulatory policy changes to RA colleagues and relevant line functions via written communication such as newsletters, information e-mails etc.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.Ensure 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 if 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.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 management 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.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.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. Collaborate 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 dashboards and trackers to help streamline operational and reporting of activities.Achievement of Regulatory compliance deliverables as per global/regional/cluster targets.Ensure number of escalation issues-out of compliance cases and mitigation plans. Creation of required dashboards and trackers to help streamline operational and reporting of activities.Timely and accurate tracking and reporting.Proof of implementation of process improvements associated to compliance.Addresses issues related to compliance with urgency with escalations as appropriate.Integrity & Compliance: Works with Integrity & Compliance policies and all company policies and ensures those around him/her do the same. Works to ensure a diverse and inclusive environment free from all forms of discrimination and harassment.Minimum Requirements: Functional Breadth.Cross Cultural Experience.Operations Management and Execution.Minimum of 1-3 years' experience as RA Manager and managing direct reports. Minimum 3 to 5 years' experience in pharmaceutical regulatory affairs environment. Knowledge and experience: Knowledge of Regulatory requirements for Medicines in the East and Southern Africa/ EAC & SADC countries. A good understanding of pharmacology, pharmaceutical and clinical data and the pharmaceutical market. Ability to implement and drive execution. Behaviours: Attention to details, Pro-active, People-orientated, Organizational awareness. Operations management and execution. Project management. Ability to travel and represent the organization. Demonstrated experience to manage people/ collaborate effectively with other functions.
Skills: Strategic mindset, Analytical and critical thinking; Detail oriented and organized; Ability to set standards and objectives and monitor progress; Prioritize workload to tight deadlines; Excellent communication; Cross functional ability/ Good interpersonal skills; Innovative, problem solving and decision making ability.Negotiation Skills.Regulatory Compliance.Languages : English.Skills Desired Clinical Trials, Detail-Oriented, Drug Development, Life Science, Negotiation, Regulatory Compliance.
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