Regulatory Affairs Pharmacist

Ithemba Recruitment- Sourcing Top Talent; Johannesburg; On-site; ZAR 200 000 - 300 000; Full time

Job summary

A leading recruitment agency is looking for a Regulatory Affairs Pharmacist to manage product applications and ensure compliance with regulations. The ideal candidate will hold a Bachelor of Pharmacy Degree and have at least 2 years of experience in regulatory affairs. This role involves liaising with various departments, managing documentation, and keeping up with legislative changes. Candidates should have strong skills in Microsoft Office and attention to detail. Experience in pharmacovigilance is advantageous.

Qualifications

• Minimum 2 years experience in regulatory affairs in any regulated regions.
• Pharmacovigilance is an advantage.
• Attention to detail is crucial.

Responsibilities

• Responsible for new product applications.
• Compile and submit Post Registration amendments to ensure compliance.
• Manage regulatory documentation filing system and ensure compliance.

Skills

Docubridge

Sage

Smartsheet

Sweet process

Microsoft Excel

Microsoft Word

Microsoft PowerPoint

Microsoft Outlook

Education

Bachelor of Pharmacy Degree

Job description

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