Regulatory Affairs Pharmacist (Fixed-Term)

Major accountabilities:

• Successful implementation of regulatory strategies and planning & execution of registration plans/projects related to submissions and approvals for 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 SAC.
• Monitor, identify and communicate emerging policy information and regulatory intelligence. Support collection and maintenance of regulatory requirements, monitor internal and external solution trends (CTA Hub, third party etc.)
• Support and update local/Regional Working Practices or SOPs when required.
• Ensure adherence to Global and local/regional processes.
• Evaluation of changes for impact on product supply. Ensure the relevant stakeholders e.g., Supply Chain Management, QA and Marketing are aware of any impact.
• Maintain all necessary Novartis databases (e.g., DRAGON, REDI-GO, etc.) to always ensure regulatory compliance.
• Responding to the requests adequately, satisfactorily, and timeously for both internal and external customers.
• Provide technical and scientific support to Medical, Market Access, Supply Chain, Marketing and QA. Review and approval of marketing promotional materials
• Ensure prompt submission of post approval commitments, PSUR submissions, RMP submissions, SLC updates and ensure timely responses to HA as required.
• 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.
• Drive collaboration within RA team and cross functionally.
• Corporate Governance: Performing all daily activities in line with the Novartis policies and Code of Conduct
• Support Novartis culture journey and role model Novartis V&B.

Key performance indicators:

• 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 

Computer literate MS office, excel and PowerPoint
Work Experience:

• Minimum 2-4 years’ experience in pharmaceutical regulatory affairs environment.
• Knowledge and experience: Knowledge of Regulatory requirements for Medicines in the Southern Africa countries e.g. Botswana, Namibia, Zambia, Zimbabwe, Mauritius, etc.
• 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.
• Project management
• Ability to travel and represent the organization
• Demonstrated experience to collaborative effectively with other functions

Skills:

• Analytical and Interpretive;
• 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

Languages :

• Fluency in English as a business language. Portuguese/ French is a plus.