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.
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 African Development Community (SADC) region, by ensuring successful Marketing Authorisation and variation approval from the Regulatory Authorities of the member states within the committed timeframe.
KEY RESPONSIBILITIES
Provide regulatory and administrative support to optimise Regulatory processes and record-keeping.
Effective utilization of resources to keep processes cost effective.
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.
Initiate change controls and action items in the eQMS.
Track medicinal samples for registration submissions and development work.
Type, print, copy, scan and bind documents.
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.
Ensure delivery and/or collections to and from SAHPRA.
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.
Maintain and manage 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.
Monitor temperatures of both medication storerooms daily and record deviations.
Submit Site Master Files (SMFs) to SAHPRA.
Ensure regulatory submissions are signed by a pharmacist.
Comply with regulations, guidelines, policies, procedures, and work instructions.
Provide feedback to pharmacist's/line manager once tasks are completed.
Escalate possible risks, critical issues which could result in delayed submissions.
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
Planning and organisational skills
Focused
Cooperation
Proactive
Responsibility & Accountability
Resilience
Active listening skills
Presentation skills
Flexibility and tolerance for ambiguity
Perseverance and tenacity
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.
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