Regulatory Affairs Pharmacist

2 weeks ago

Parktown, South Africa The Perfect Placements Full time

Our client, a leading company in the pharmaceuticals industry is looking for qualified, career-driven, motivated, passionate, results-driven, team player, analytical and resilient Regulatory Affairs Pharmacist.
- **This position will be based at their head office in Parktown, Gauteng**_

**Key Performance Areas**:

- 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

**Skills and Competencies**:

- Docubridge
- Sage
- Smartsheet
- Sweet process
- Microsoft: Excel, Word, PowerPoint, Outlook
- Takes ownership and is assertive
- Integrity, bound to principles, confidentiality, and ethics.
- Strong leadership skills.
- Good communication and organisational skills.
- Good planning and follow up skills.
- Attention to detail
- Conscientious.
- Patient and Co-operative.
- Deadline Driven

**Education and Experience**:

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

**Travel**:

- SAHPRA
- Suppliers

**Salary**:

- R60 000 - R80 000pm based on experience

If you think you are the perfect fit, please submit a head and shoulders picture along with your updated CV

**Job Types**: Full-time, Permanent

**Salary**: R60,000.00 - R80,000.00 per month

Ability to commute/relocate:

- Parktown, Gauteng: Reliably commute or planning to relocate before starting work (preferred)

**Education**:

- Bachelors (required)

**Experience**:

- Regulatory Affair Regions: 2 years (required)
- Regulatory Affairs: 2 years (required)

Willingness to travel:

- 50% (preferred)

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