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Job Summary
MAIN PURPOSE OF JOB
- Medicines Registration and Maintenance of Product Licenses with various Health Authorities in African countries
RESPONSIBILITIES
- Responsible for new product applications.
- Compilation and submission of Post –Registration amendments to ensure dossier compliance.
- Responsible for pre and post registration SAHPRA Committee recommendation responses to ensure product registration.
- Responsible for dossier updates, PI/PIL updates to ensure compliance with current legislation
- To ensure approval and compliance of printed packaging material and promotional marketing material.
- Liaising with marketing department to facilitate timeous launch of products.
- Approval of master batch documentation prior to product production.
- Responsible for SOP implementation/review, update and compliance.
- Managing and maintaining regulatory documentation filing system.
- Ensuring regulatory compliance and quality related records are available and retained.
- Ensure on-going regulatory compliance of the existing product portfolio.
- Ensure awareness of legislative changes and trends that will impact the core function of the regulatory affairs department and hence the marketability of company products
- Liaise with business development for regulatory requirements prior to dossier acquisition.
QUALIFICATIONS & EXPERIENCE
- B. Pharm Degree
- Minimum 2 years’ experience in regulatory affairs in any regulated regions e.g., South Africa Europe, UK, Australia, Canada, Japan
SKILLS/PHYSICAL COMPETENCIES
- Docubridge
- Sage
- Smartsheet
- Sweet process
- Microsoft: Excel, Word, PowerPoint, Outlook
BEHAVIOURAL QUALITIES
- Takes ownership.
- Integrity, bound to principles, confidentiality, and ethics.
- Strong leadership skills.
- Good communication skills.
- Good organisational skills.
- Good planning skills.
- Good follow-up skills
- Attention to detail
- Assertive.
- Conscientious.
- Patient.
- Co-operative.
- Deadline Driven
OttoBauthentic
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