Regulatory Affairs Pharmacist

5 days ago

Johannesburg, South Africa Ad Talent Africa Full time

**Who are we**: An innovative leading pharmaceutical company.

**Who are we looking for**: A Regulatory Affairs Pharmacist.

**What will you do**:

- 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 timeous 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

**What do you need**:

- Bachelor of pharmacy degree
- Minimum 2 years’ experience in **regulatory affairs **in any regulated regions e.g., South Africa, Europe, UK, Australia, Canada, Japan

**Skills**:

- Docubridge
- Sage
- Smartsheet
- Sweet process
- Microsoft: Excel, Word, PowerPoint, Outlook

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