Job Description Summary<\/p>\n
\tTo support registration\/approval of new products, line extensions, new indications, clinical trials, variations, support regulatory maintenance activities of the registered base portfolio, ensure optimization and regulatory compliance.
\n\tSupport regulatory maintenance activities and ensure optimization and compliance for registered as well as managing all regulatory matters in all spheres of activity [Registration, Production\/NTO, Marketing supply chain (SC), Patient safety (PS), Quality Assurance (QA), etc.] and to provide internal and external scientific and marketing advice\/expertise.
\n\tTo support submission and communication of PV related reports, QA related matters.
\n\tSupport in engagement and collaboration with internal stakeholders as well as establishment and maintenance of strong working relationships with key external stakeholders.
\n\tTo support in monitoring and communication of 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 Southern Africa countries (SAC).<\/p>\n
Job Description<\/p>\n
Major accountabilities:\u00a0<\/p>\n
\tSuccessful 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.
\n\tPerformance of due diligence of dossier information\/registration documents received from global and other appropriate sources.
\n\tEnsure timeous compilation, submission, and approval of variation applications. Review and submission of all variations\/amendments according to the Global and HA Guidelines.
\n\tSupport in engagement & collaboration with internal stakeholders as well as establishment and maintenance of strong working relationships with key external stakeholders.
\n\tSupport development and maintenance of dashboards and trackers designed to improve regulatory processes within SAC.
\n\tMonitor, 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.)
\n\tSupport and update local\/Regional Working Practices or SOPs when required.
\n\tEnsure adherence to Global and local\/regional processes.
\n\tEvaluation of changes for impact on product supply. Ensure the relevant stakeholders e.g., Supply Chain Management, QA and Marketing are aware of any impact.
\n\tMaintain all necessary Novartis databases (e.g., DRAGON, REDI-GO, etc.) to always ensure regulatory compliance.
\n\tResponding to the requests adequately, satisfactorily, and timeously for both internal and external customers.
\n\tProvide technical and scientific support to Medical, Market Access, Supply Chain, Marketing and QA. Review and approval of marketing promotional materials
\n\tEnsure prompt submission of post approval commitments, PSUR submissions, RMP submissions, SLC updates and ensure timely responses to HA as required.
\n\tEnsure issues of non-compliance are handled with urgency and appropriate channels are engaged in a timely manner when necessary.
\n\tEnsure compliance to global and local KPIs.
\n\tDrive collaboration within RA team and cross functionally.
\n\tCorporate Governance: Performing all daily activities in line with the Novartis policies and Code of Conduct
\n\tSupport Novartis culture journey and role model Novartis V&B.<\/p>\n
Key performance indicators:\u00a0<\/p>\n
\tNumber 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.
\n\tEnsure timely submission and communication of PV related reports (e.g. PSUR, RMP, HA request, safety concerns, etc.) and QA related matters.
\n\tAchievement of Regulatory compliance deliverables as per global\/regional\/cluster targets within the assigned county\/cluster.
\n\tProactive communication of new and evolving regulatory requirements to relevant stakeholders.
\n\tTimely and accurate tracking of relevant information.
\n\tStrong working relationships with key stakeholders (HAs and other external stakeholders)
\n\tMaintaining minimum of 95% DRAGON compliance in update of new received post distribution changes to normal country folders and brand safety folders
\n\tKeeping and improving strong relations with Health Authority’s officials\u00a0
\n\tProduct Deliveries to the markets according to plans (no stock outs due to out of compliance).
\n\tProviding regulatory guidance on promotional material and support with HA approvals.
\n\tProvide technical and scientific support to Medical, Market Access, Supply Chain, Marketing and QA.<\/p>\n
Minimum Requirements:\u00a0<\/p>\n
\tB.Pharm \u00a0
\n\tComputer literate MS office, excel and PowerPoint\u00a0<\/p>\n
Work Experience:\u00a0<\/p>\n
\tMinimum 2-4 years\u2019 experience in pharmaceutical regulatory affairs environment.\u00a0
\n\tKnowledge and experience: Knowledge of Regulatory requirements for Medicines in the Southern Africa countries e.g. Botswana, Namibia, Zambia, Zimbabwe, Mauritius, etc.\u00a0
\n\tA good understanding of pharmacology, pharmaceutical and clinical data and the pharmaceutical market\u00a0
\n\tAbility to implement and drive execution.
\n\tBehaviours: Attention to details, Pro-active, People-orientated, Organizational awareness.\u00a0
\n\tProject management\u00a0
\n\tAbility to travel and represent the organization
\n\tDemonstrated experience to collaborative effectively with other functions<\/p>\n
Skills<\/p>\n
\tAnalytical and Interpretive
\n\tDetail oriented and organized\u00a0
\n\tAbility to set standards and objectives and monitor progress
\n\tPrioritize workload to tight deadlines
\n\tExcellent communication;
\n\tCross functional ability\/Good interpersonal skills
\n\tInnovative, problem solving and decision-making ability<\/p>\n
Languages :<\/p>\n
\tFluency in English as a business language. Portuguese\/ French is a plus.
\n\tNovartis South Africa is committed to promoting equity (race, gender, and disability) through the filling of this post with a candidate whose transfer\/promotion\/appointment will promote representivity in line with the numerical targets as contained in our Employment Equity plan.
\n\tWhile we are prioritizing designated groups, our selection process will still be based on the most suitable candidate, with the necessary skills and experience, as outlined in the job description.<\/p>\n
Skills Desired<\/p>\n
\tAnalytical Skill, Clinical Trials, Collaboration, Detail-Oriented, Lifesciences, Project Planning, Regulatory Compliance<\/p>\n
Apply via company website ( http:\/\/www.novartis.com ) or<\/p>\n
novartis.wd3.myworkdayjobs.com<\/p>\n
<\/p>\n","protected":false},"author":2,"featured_media":0,"template":"","meta":{"_promoted":"","_job_location":"","_application":"http:\/\/novartis.wd3.myworkdayjobs.com","_company_name":"Novartis","_company_website":"http:\/\/www.novartis.com","_company_tagline":"Novartis provides healthcare solutions that improve and extend people\u2019s lives. We use science-based innovation to address some of society\u2019s most challenging healthcare issues. We discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible. Our com... read morepany is focused on industry-leading divisions with innovation power and global scale: pharmaceuticals, eye care and generic medicines Novartis is headquartered in Basel, Switzerland. Novartis Group companies employ approximately 120,000 associates and its products are available in more than 180 countries around the world. Novartis South Africa (Pty) Ltd 72 Steel Road Spartan ZA- Kempton Park, Gauteng 1619 South Africa","_company_twitter":"","_company_video":"","_filled":0,"_featured":0,"_remote_position":0,"_job_salary":"","_job_salary_currency":"","_job_salary_unit":""},"job_listing_region":[11],"job-types":[18],"class_list":{"0":"post-15631","1":"job_listing","2":"type-job_listing","3":"status-expired","4":"hentry","5":"job_listing_region-gauteng","7":"job-type-contract"},"jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job-listings\/15631","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job-listings"}],"about":[{"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/types\/job_listing"}],"author":[{"embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/users\/2"}],"wp:attachment":[{"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/media?parent=15631"}],"wp:term":[{"taxonomy":"job_listing_region","embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job_listing_region?post=15631"},{"taxonomy":"job_listing_type","embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job-types?post=15631"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}