OBJECTIVE OF ROLE<\/p>\n
\tTo support the SA Commercial Business to realize the commercial strategy and to achieve the annual targeted growth and revenue through successful new product introductions and maintenance of current product portfolio in the (South Africa OR South African Development Community (SADC) region), by ensuring successful Marketing Authorisation and variation approval from the (SAHPRA OR Regulatory Authorities of the member states) within the committed timeframe.<\/p>\n
The role undertakes responsibility for compliance with the Regulatory requirements for the existing product portfolio in the region, through the successful completion of assigned activities according to the (South African OR SADC) Regulatory plan.<\/p>\n
\tTo provide regulatory and administrative support to optimize Regulatory processes and record-keeping.<\/p>\n
KEY RESPONSIBILITIES<\/p>\n
FINANCIAL<\/p>\n
\tEffective utilization of resources to keep processes cost effective<\/p>\n
CUSTOMER<\/p>\n
\tDisplay a professional attitude when responding to customers
\n\tPropose, develop and update methods to improve customer services
\n\tEffective liaison and communication with internal and external customers, including but not limited to Regulatory Authorities, external consultants and agents, Quality Assurance, Project Managers, Artwork, New Product Launches, Manufacturing sites, Pharmacovigilance, Medical Information, AGI, APTL<\/p>\n
3. SYSTEMS, DATABASES AND TRACKERS<\/p>\n
\tInitiate change controls and action items in the eQMS
\n\tTrack medicinal samples for registration submissions and development work
\n\tIdentify, track, and manage free space available in safes
\n\tTrack internal and off-site archiving
\n\tEnter SMF information into relevant databases<\/p>\n
4. ADMINISTRATIVE<\/p>\n
\tType, print, copy, scan and bind documents
\n\tRetrieve from and return IP to safes
\n\tCreate, label and archive files
\n\tReceive Local Document Archiving Forms. Allocate space for new files in the safes and update IP Database
\n\tEnsure sufficient free space available in the safes, and if required, consulting with the line manager to identify which files can be archived off-site
\n\tRequest payments and provide proof of payment to the requestor
\n\tEnsure delivery and\/or collections to and from SAHPRA
\n\tArranging for drivers to deliver\/collect documents\/samples as and when required.
\n\tEnsure proof of receipt of SAHPRA submissions and correct filing
\n\tSend parcels (documents, samples, CD\u2019s etc.) and supportive documentation to Regulatory Authorities, agents and\/or other Aspen departments via courier
\n\tAssist in updates of SOP\u2019s, working instructions, standard forms, templates as they relate to the administrative functions of the department
\n\tUpload submissions to SAHPRA FTP
\n\tAssist with administrative tasks on SAHPRA Engagement Portal.
\n\tRequest import permit, export permit or import\/export authorization letters from SAHPRA
\n\tProvide training on administrative procedures to new\/existing personnel
\n\tMaintain hard copy and electronic training matrix, hard copy training records and training files
\n\tArrange meetings, training, functions, venues, catering
\n\tManage meeting agendas and take minutes
\n\tReceive and collate monthly reports
\n\tReceive, collate, and submit leave forms, expense claims, time sheets, invoices
\n\tMaintain and managing team lists e.g. birthdays, working hours, employee numbers
\n\tAssist with induction process for new employees
\n\tOrder stationery
\n\tRemove documents for shredding<\/p>\n
5. OFF-SITE ARCHIVING<\/p>\n
\tRequest retrieval of boxes from off-site
\n\tTrack movement of products removed from boxes, and ensuring requestor signature
\n\tMeeting with the archive vendor as and when required
\n\tTrack on-site stock of boxes from off-site
\n\tEnsure product information is received, sealed and then returned off-sit<\/p>\n
6. MEDICATION SAMPLES<\/p>\n
\tMonitor temperatures electronically of both medication storerooms daily and record deviations
\n\tPack expired medicinal stock for destruction according to process and track accordingly
\n\tOrder, receive, dispatch and track medicinal samples for investigation and registration purposes as required
\n\tStorage of medicinal sample documentation as per process
\n\tNotify relevant personnel of receipt of samples as per process
\n\tManage and record the monthly stock take of all medicinal samples, as per process.<\/p>\n
7. SITE MASTER FILES<\/p>\n
\tSubmit Site Master Files (SMFs) to SAHPRA
\n\tRecord SMF information on relevant network drive\/systems
\n\tLiaise with SAHPRA on the allocation of an SMF number
\n\tSend notification of submission\/receipt of SMF numbers to the relevant personnel as per process<\/p>\n
8. REGULATORY SUPPORT<\/p>\n
\tSupersede dossiers for specific regulatory activities as per departmental working instruction
\n\tEnsure relevant history\/status documents are updated
\n\tSource regulatory information from dossiers under supervision
\n\tCompile follow up letters\/extension requests and submit them to the Regulatory Authorities
\n\tCompile, publish and submit pre- and post-registration sequences
\n\tConduct newly registered compliance checks under supervision
\n\tExecute discontinuation and cancellation requests, as per process
\n\tSend notification of submission to relevant stakeholders<\/p>\n
GENERAL<\/p>\n
\tMaintaining electronic folder structure and eCTD templates as per departmental procedures
\n\tMaintain all hard copy registration certificates in the ground floor cage, as required
\n\tComply with regulations, guidelines, policies, procedures, and work instructions
\n\tAdhere to deadlines\/due dates
\n\tProvide feedback to pharmacists and line manager once tasks are completed
\n\tEscalate possible risks, critical issues which could result in delayed submissions
\n\tAssist with ad hoc tasks as allocated by the line manager.<\/p>\n
LEARNING AND GROWTH<\/p>\n
\tTraining and development identified and planned with the line manager
\n\tTraining is implemented according to ongoing personal and team development plans
\n\tUp-skilling and multi-skilling are coordinated in line with staff development<\/p>\n
Requirements<\/p>\n
EDUCATIONAL REQUIREMENTS<\/p>\n
\tMatric\/Grade 12<\/p>\n
KNOWLEDGE & EXPERIENCE REQUIREMENTS<\/p>\n
\tKnowledge of pharmaceutical industry\/regulatory affairs
\n\tExperience in administrative work is essential<\/p>\n
SOFT SKILLS AND COMPETENCY REQUIREMENTS<\/p>\n
\tResults oriented
\n\tSystems thinking
\n\tPlanning, multi-tasking and organizational skills
\n\tFocused, Cooperative and Proactive
\n\tResponsible and accountable
\n\tResilient, Self-awareness and High standards
\n\tGood communication and active listening skills
\n\tPresentation skills
\n\tFlexibility and tolerance for ambiguity
\n\tTransition management
\n\tCapacity for resistance to stress
\n\tPerseverance and tenacity
\n\tOptimistic and passionate
\n\tCurious with a strong learning agility<\/p>\n
COMPUTER SKILLS REQUIRED<\/p>\n
\tThe applicant must be proficient in the various applications (Outlook, Teams, Word, Excel and PowerPoint) within the Microsoft Office 365 Bundle.<\/p>\n
go to method of application \u00bb<\/p>\n
Apply via company website ( ) or<\/p>\n
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