Job Description

COMPANY DESCRIPTION
We are a global specialty and branded pharmaceutical company, improving the health of patients across the world through our high quality and affordable medicines. Active at every stage of the value chain, we are uniquely diversi?ed by geography, product and manufacturing capability.
Aspen is a dynamic organization built on entrepreneurial strength and forward-thinking minds. We attract high performing individuals who are passionate about their career and have a desire to exceed expectations. At Aspen, not only do we source for the best talent, but we also provide a host of opportunities for continuous development.
The Group's key business segments are Manufacturing and Commercial Pharmaceuticals comprising Regional Brands and Sterile Focus Brands. We have approximately 9 100 employees at 69 established offices in over 50 countries and we improve the health of patients in more than 150 countries through our high quality, affordable medicines.
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
1.FINANCIAL
Effective utilization of resources to keep processes cost effective
2.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-site
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

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.
FEEDBACK
Please note that if you have not heard from the Human Capital department within 30 days of this advert closing, your application has unfortunately been unsuccessful.
INTERNAL APPLICATIONS
Internal Applications must be completed using an Aspen mailing address after applicants have had informed their direct line managers of their application for this specific role.
Aspen is committed to the principles of equal employment opportunity. Preference will be given to Employment Equity candidates in line with Aspen's Transformation Agenda.

Skills Required