Job title: Regulatory Affairs Assistant (Temp)
Company: Aspen Pharmacare
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 diversified by geography, product, and manufacturing capability.
Aspen is a dynamic organisation 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: 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.
KEY RESPONSIBILITIES:
- Provide regulatory and administrative support to optimise Regulatory processes and record-keeping.
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.
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, consult 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.
- Arrange 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.
- Upload submission to SAHPRA via their Digital Variations Portal (DVP).
- Request import permit, export permit or import/export authorisation letters from SAHPRA.
- 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 manage team lists e.g. birthdays, half days, working hours, employee numbers.
- Assist with the 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, 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:
- Monitor 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:
- 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.
- Send notification of submission to relevant stakeholders.
- Ensure regulatory submissions are signed by a pharmacist.
GENERAL:
- Maintain electronic folder structure as per departmental procedures.
- Comply with regulations, guidelines, policies, procedures, and work instructions.
- Adhere to deadlines/due dates.
- Provide feedback to pharmacists/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.
EDUCATIONAL REQUIREMENTS:
- Matric/Grade 12.
- Diploma in Life Sciences, Biomedical Sciences or equivalent.
KNOWLEDGE & EXPERIENCE REQUIREMENTS:
- Experience with administrative work (3 years preferred).
- Knowledge of Pharmaceutical industry/regulatory affairs.
SOFT SKILLS REQUIREMENTS:
- Multi-tasking.
- Results oriented.
- Systems thinking.
- Planning and organisational 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.
COMPUTER SKILLS REQUIRED: The applicant must be proficient in Word, Excel, Outlook. Preference will be given to previously disadvantaged groups. Suitably qualified applicants are invited to submit their CV’s online on or before 04 November 2024. Please note that if you have not heard from the HR department within 30 days of this advert closing, your application has unfortunately been unsuccessful. Internal Applications must be completed using an Aspen mailing address after applicants have informed their direct line managers of their application for this specific role.
Expected salary:
Location: Johannesburg, Gauteng
Job posting date: Fri, 01 Nov 2024 07:50:11 GMT
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