Job Description

JOB OVERVIEW:
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 SOPs
• 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

MINIMUM REQUIREMENTS:

• Education:

o B. Pharm (Bachelor of pharmacy)
o Registration with the South African Pharmacy Council (SAPC)

• Job Training and Experience:

o Minimum 5 years experience in Regulatory Affairs - (must have human medicine experience and biologicals)
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 Microsoft office suite including Word, Excel, Power Point at an Intermediate level.
o Familiar with ZAZIBONA processes
o Competent and experienced in eCTD submissions.

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