Aspen Pharma Group
OBJECTIVE OF ROLE
To 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.
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.
To provide regulatory and administrative support to optimize Regulatory processes and record-keeping.
KEY RESPONSIBILITIES
FINANCIAL
Effective utilization of resources to keep processes cost effective
CUSTOMER
Display a professional attitude when responding to customers
Propose, develop and update methods to improve customer services
Effective 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
3. SYSTEMS, DATABASES AND TRACKERS
Initiate change controls and action items in the eQMS
Track medicinal samples for registration submissions and development work
Identify, track, and manage free space available in safes
Track internal and off-site archiving
Enter SMF information into relevant databases
4. ADMINISTRATIVE
Type, print, copy, scan and bind documents
Retrieve from and return IP to safes
Create, label and archive files
Receive Local Document Archiving Forms. Allocate space for new files in the safes and update IP Database
Ensure sufficient free space available in the safes, and if required, consulting with the line manager to identify which files can be archived off-site
Request payments and provide proof of payment to the requestor
Ensure delivery and/or collections to and from SAHPRA
Arranging for drivers to deliver/collect documents/samples as and when required.
Ensure proof of receipt of SAHPRA submissions and correct filing
Send parcels (documents, samples, CD’s etc.) and supportive documentation to Regulatory Authorities, agents and/or other Aspen departments via courier
Assist in updates of SOP’s, working instructions, standard forms, templates as they relate to the administrative functions of the department
Upload submissions to SAHPRA FTP
Assist with administrative tasks on SAHPRA Engagement Portal.
Request import permit, export permit or import/export authorization letters from SAHPRA
Provide training on administrative procedures to new/existing personnel
Maintain hard copy and electronic training matrix, hard copy training records and training files
Arrange meetings, training, functions, venues, catering
Manage meeting agendas and take minutes
Receive and collate monthly reports
Receive, collate, and submit leave forms, expense claims, time sheets, invoices
Maintain and managing team lists e.g. birthdays, working hours, employee numbers
Assist with induction process for new employees
Order stationery
Remove documents for shredding
5. OFF-SITE ARCHIVING
Request retrieval of boxes from off-site
Track movement of products removed from boxes, and ensuring requestor signature
Meeting with the archive vendor as and when required
Track on-site stock of boxes from off-site
Ensure product information is received, sealed and then returned off-sit
6. MEDICATION SAMPLES
Monitor temperatures electronically of both medication storerooms daily and record deviations
Pack expired medicinal stock for destruction according to process and track accordingly
Order, receive, dispatch and track medicinal samples for investigation and registration purposes as required
Storage of medicinal sample documentation as per process
Notify relevant personnel of receipt of samples as per process
Manage and record the monthly stock take of all medicinal samples, as per process.
7. SITE MASTER FILES
Submit Site Master Files (SMFs) to SAHPRA
Record SMF information on relevant network drive/systems
Liaise with SAHPRA on the allocation of an SMF number
Send notification of submission/receipt of SMF numbers to the relevant personnel as per process
8. REGULATORY SUPPORT
Supersede dossiers for specific regulatory activities as per departmental working instruction
Ensure relevant history/status documents are updated
Source regulatory information from dossiers under supervision
Compile follow up letters/extension requests and submit them to the Regulatory Authorities
Compile, publish and submit pre- and post-registration sequences
Conduct newly registered compliance checks under supervision
Execute discontinuation and cancellation requests, as per process
Send notification of submission to relevant stakeholders
GENERAL
Maintaining electronic folder structure and eCTD templates as per departmental procedures
Maintain all hard copy registration certificates in the ground floor cage, as required
Comply with regulations, guidelines, policies, procedures, and work instructions
Adhere to deadlines/due dates
Provide feedback to pharmacists and line manager once tasks are completed
Escalate possible risks, critical issues which could result in delayed submissions
Assist with ad hoc tasks as allocated by the line manager.
LEARNING AND GROWTH
Training and development identified and planned with the line manager
Training is implemented according to ongoing personal and team development plans
Up-skilling and multi-skilling are coordinated in line with staff development
Requirements
EDUCATIONAL REQUIREMENTS
Matric/Grade 12
KNOWLEDGE & EXPERIENCE REQUIREMENTS
Knowledge of pharmaceutical industry/regulatory affairs
Experience in administrative work is essential
SOFT SKILLS AND COMPETENCY REQUIREMENTS
Results oriented
Systems thinking
Planning, multi-tasking and organizational skills
Focused, Cooperative and Proactive
Responsible and accountable
Resilient, Self-awareness and High standards
Good communication and active listening skills
Presentation skills
Flexibility and tolerance for ambiguity
Transition management
Capacity for resistance to stress
Perseverance and tenacity
Optimistic and passionate
Curious with a strong learning agility
COMPUTER SKILLS REQUIRED
The applicant must be proficient in the various applications (Outlook, Teams, Word, Excel and PowerPoint) within the Microsoft Office 365 Bundle.
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