Regulatory Affairs Assistant (JHB North) at 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.