Regulatory Affairs Assistant : Variations (On-Site) (Gauteng) at Aspen Pharma Group

PURPOSE:

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 for the New Product Launch Pipeline and 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. 

MAIN DUTIES

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

SYSTEMS, DATABASES AND TRACKERS

• Initiate change controls and action items in Trackwise
• 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 onto relevant databases
• Utilise systems, databases, and trackers to provide accurate information to internal and external customers on request

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 and maintain a delivery/collections log
• 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, forms, templates as they relate to the administrative functions of the department
• Provide training on administrative procedures to new/existing personnel
• Maintain hard copy and electronic training matrix, 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, overtime forms, expense claims, timesheets, invoices
• Maintain and managing team lists e.g. birthdays, half days, working hours, employee numbers
• Assist with induction process for new employees
• Order stationery and stock the stationary cupboard
• Remove documents for shredding

OFF-SITE ARCHIVING

• Request retrieval of boxes from off-site
• Track movement of products removed from boxes, and ensuring requestor signature
• Track on-site stock of boxes from off-site
• Ensure product information is returned, sealed and then returned off-site

MEDICATION SAMPLES

• Log temperatures of both medication storerooms daily and record deviations
• Pack expired medicinal stock for destruction according to process and track accordingly
• Order, receive and track medicinal samples for investigational and registration purposes as required
• Notify relevant personnel of receipt of samples as per process

SITE MASTER FILES

• Print and 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

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 to the Regulatory Authorities
• Compile post-screening copies as required by SAHPRA, and submit
• Send notification of submission to relevant stakeholders
• Post-registration administrative activities of newly registered products
• Ensure regulatory submissions are signed by a pharmacist

GENERAL

• Maintaining electronic folder structure as per departmental procedures
• Comply with regulations, guidelines, policies, procedures, and work instructions
• Adhere to deadlines/due dates
• Provide feedback to pharmacist’s/line manager once tasks are completed
• Escalate possible risks, critical issues which could result in delayed submissions

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

SKILLS AND ATTRIBUTES

• Multi-tasking
• Results oriented
• Systems thinking
• Planning and organizational skills
• Focused
• Cooperation
• Proactive
• Responsibility & Accountability
• Resilience
• Informal communications skills
• Active listening skills
• Presentation skills
• Flexibility and tolerance for ambiguity
• Transition management
• Capacity for resistance to stress
• Perseverance and tenacity
• Understands Aspen story
• Aspen knowledge
• Optimism
• Passion
• Curiosity/learning agility
• Self-awareness
• High standards

EDUCATION & EXPERIENCE

• Matric/Grade 12
• Must be proficient in Word, Excel, Outlook
• At least 2 years experience with administrative work
• Knowledge of pharmaceutical industry/regulatory affairs