Regulatory Affairs Pharmacist - Johannesburg, South Africa - Curiska (Pty) Ltd

Curiska (Pty) Ltd

Verified Company

Johannesburg, South Africa

1 week ago

Posted by:

Thabo Mthembu

beBee Recruiter

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 inline 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.
Coordinate product recall or market withdrawal when necessary
Obtain and distribute updated information on domestic and international laws
Report ADR to Global Safety and SAHPRA
Followup of Adverse Drug Reactions (ADRs),
Pharmacovigilance training of local staff
Answering of requests from the Regulatory Authority with cooperation with Global Safety

MINIMUM REQUIREMENTS:

Education:
B. Pharm (Bachelor of pharmacy)
Registration with the South African Pharmacy Council (SAPC)
Job Training and Experience:
Minimum 5 years' experience in Regulatory Affairs (must have human medicine experience and biologicals)
Experience in Product registration (NCE)
Maintenance of dossiers and updating thereof
Pharmacovigilance experience / knowledge of collecting and reporting
Knowledge of SAHPRA submission portals
Launch procedures for new products
Knowledgeable and experience regarding QA processes, APQRs, customer complaints etc.
In depth knowledge of Regulations, Acts and Guidelines for South Africa and East Africa pertaining to dossier submissions and life cycle management.
Knowledge of the Marketing Code
Systems knowledge
Microsoft office suite including Word, Excel, Power Point at an Intermediate level.
Familiar with ZAZIBONA processes
Competent and experienced in eCTD submissions.