Senior Regulatory affairs pharmacist

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:

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.