Regulatory Affairs Pharmacist, Johannesburg

About the job Regulatory Affairs Pharmacist To fulfill the position as regulatory affairs pharmacist for the company and any division within the group.

Key purpose Duties and responsibilities

Responsible for new product applications.

Compilation and submission of Post Registration amendments to ensure dossier compliance.

Responsible for pre and post registration SAHPRA Committee recommendation responses to ensure product registration.

Responsible for dossier updates, PI/PIL updates to ensure compliance with current legislation.

To ensure approval and compliance of printed packaging material and promotional marketing material.

Liaising with marketing department to facilitate timely launch of products.

Approval of master batch documentation prior to product production.

Responsible for SOP implementation/review, update and compliance.

Managing and maintaining regulatory documentation filing system.

Ensuring regulatory compliance and quality related records are available and retained.

Ensure on-going regulatory compliance of the existing product portfolio.

Ensure awareness of legislative changes and trends that will impact the core function of the regulatory affairs department and hence the marketability of company products.

Liaise with business development for regulatory requirements prior to dossier acquisition.

Training and peer review of documents.

Qualifications and experience

Bachelor of Pharmacy Degree

Minimum 2 years experience in regulatory affairs in any regulated regions e.g., South Africa, Europe, UK, Australia, Canada, Japan

Pharmacovigilance is an advantage

2 Years experience in regulatory affairs and attention to detail

Skills and competencies

Docubridge

Sage

Smartsheet

Sweet process

Microsoft: Excel, Word, PowerPoint, Outlook

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