job description - Regulatory Affairs Pharmacist
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.
- Training and peer review of documents.
Education and Requirements:
- Bachelor of Pharmacy Degree
Skills and Competencies:
- Minimum 2 years’ experience in regulatory affairs in any regulated regions e.g., South Africa Europe, UK, Australia, Canada, Japan
- Pharmacovigilance experience will be an advantage.
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About the company
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We provide products of the highest international standard, underpinned by clinically proven safety and efficacy.