Job Description

Summary -Contributes and support the development of submission of product registration, progress reports, supplements, amendments, and/or periodic experience reports. Supports all registration activities of the Department to ensure compliance with the requisites of the local pharmaceutical regulatory environment.

• Achieve the best product registration with commercially attractive labelling in accordance with registration plan -Maintain and secure product license in terms of CMC/CDS/safety update according to local regulations/law/guidelines, company strategy and global compliance -Ensure compliance with NP4, KRPIA code of conduct, relevant regulations and laws for related CPO activities (DRAGON update, RMP, packing materials, promotional materials/activities, PMS/drug safety reporting etc.) -Foster and maintain good relations with internal and external stakeholders -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)
• Support submissions and approvals for of new products, line extensions, new indications, renewals, clinical trials, safety label changes and quality/CMC variations.
• Performance of due diligence of dossier information/registration documents received from global and other appropriate sources. Ensure timeous compilation, submission, and approval of variation applications. Review and submission of all variations/amendments according to the Global and HA Guidelines.
• Support in engagement & collaboration with internal stakeholders as well as establishment and maintenance of strong working relationships with key external stakeholders.
• Support development and maintenance of dashboards and trackers designed to improve regulatory processes within ESA.
• Monitor, identify and escalate emerging policy information and regulatory intelligence. Support collection and maintenance of regulatory requirements, monitor internal and external solution trends (CTA Hub, third party etc.)
• Communicate new and emerging regulatory requirements to RA colleagues and relevant line functions via written communication such as newsletters, information e-mails.

Key performance indicators:

• Project & stakeholder feedback -Product license update in terms of CMC in agreed timeline -Adherence to Novartis policy and guidelines
• Number of achieved standard and stretched submissions and registration/approval milestones/deliverables related to new registration, line extensions, new indications, variations, renewals, annual retentions, clinical trials.
• Ensure timely submission and communication of PV related reports (e.g. PSUR, RMP, HA request, safety concerns, etc.) and QA related matters.
• Achievement of Regulatory compliance deliverables as per global/regional/cluster targets within the assigned county/cluster.
• Proactive communication of new and evolving regulatory requirements to relevant stakeholders.
• Timely and accurate tracking of relevant information.
• Strong working relationships with key stakeholders (HAs and other external stakeholders)
• Maintaining minimum of 95% DRAGON compliance in update of new received post distribution changes to normal country folders and brand safety folders
• Keeping and improving strong relations with Health Authority's officials
• Product Deliveries to the markets according to plans (no stock outs due to out of compliance).
• Providing regulatory guidance on promotional material and support with HA approvals.
• Provide technical and scientific support to Medical, Market Access, Supply Chain, Marketing and QA.

Minimum Requirements:B.Pharm or life sciences degree or equivalentComputer literate MS office, excel and PowerPoint
Work Experience:

• Functional Breadth.
• Cross Cultural Experience.
• Operations Management and Execution.
• Project Management.

ExperiencesMinimum 1-3 yearsxe2x80x99 experience in pharmaceutical regulatory affairs environment.Knowledge and experience: Knowledge of Regulatory requirements for Medicines in the East and/or Southern Africa countriesA good understanding of pharmacology, pharmaceutical and clinical data and the pharmaceutical market Ability to implement and drive execution.Skills:

• Analytical Skill.
• Clinical Trials.
• Collaboration.
• Detail Oriented.
• Lifesciences.
• Project Planning.
• Regulatory Compliance.

Languages :

• English.

Skills Desired Auditing, Databasing, Operational Excellence, Regulatory Compliance, Regulatory Reporting, Risk Compliance

Novartis