Senior Regulatory affairs pharmacist
Curiska
- Johannesburg, Gauteng
- Permanent
- Full-time
Ensuring thorough, seamless product registration process and dossier maintenance. Ensuring that the company complies with all regulations and maintain comapanys pharmacovigilance requirements.DUTIES AND RESPONSIBILITIES:
- Provide, Lead, manage, and execute strategic direction as the regulatory affairs pharmacist
- Ensure and supervise that regulatory documentation meets relevant regulatory requirements and specifications.
- Provide input to the regulatory strategy in-line with business objectives
- Detailed understanding of regulatory guidelines and technical requirements
- Manage and implement safety updates where required
- Manage Chemistry Manufacturing and Controls (CMC / P&A) updates and variations
- To ensure approval and compliance of printed packaging material and promotional marketing material.
- License renewals with service providers i.e. SAHPRA, South African Pharmacy Council (SAPC)
- Writing and developing of SOP in line with Global SOP’s
- Manage internal and external audits (i.e.Global & SAHPRA)
- Responsible for updates of dossiers, PI/PIL to ensure compliance with current legislation
- Manage of product complaints and deviations
- Managing and maintaining regulatory documentation filing system.
- Ensuring regulatory compliance and quality related records are available and retained.
- Co-ordinate product recall or market withdrawal when necessary
- Obtain and distribute updated information on domestic and international laws
- Report ADR to Global Safety and SAHPRA
- Follow-up of Adverse Drug Reactions (ADRs),
- Pharmacovigilance training of local staff
- Answering of requests from the Regulatory Authority with co-operation with Global Safety
- Education:
o Registration with the South African Pharmacy Council (SAPC)
- Job Training and Experience:
o Experience in Product registration (NCE)
o Maintenance of dossiers and updating thereof
o Pharmacovigilance experience / knowledge of collecting and reporting
o Knowledge of SAHPRA submission portals
o Launch procedures for new products
o Knowledgeable and experience regarding QA processes, APQRs, customer complaints etc.
o In depth knowledge of Regulations, Acts and Guidelines for South Africa and East Africa pertaining to dossier submissions and life cycle management.
o Knowledge of the Marketing Code
- Systems knowledge
o Familiar with ZAZIBONA processes
o Competent and experienced in eCTD submissions.