Regulatory Affairs Pharmacist

7 months ago

Johannesburg, South Africa Curiska (Pty) Ltd Full time

**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 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

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.

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