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

**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)

  • Regulatory Affairs Pharmacist

    1 week 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...

  • Medical Drug Development and Regulatory Processes

    1 week ago

    Parktown, South Africa AJ Personnel Full time

    **Main purpose of the job**: - Lead the drug development and regulatory processes workstream for the market-shaping output **Location**: - **Parktown - Johannesburg** **Key performance areas**: - Lead the drug development & regulatory processes workstream - Work closely with CHAI and lead product development, regulatory, and quality assurance...

  • Project Manager

    4 days ago

    Parktown, South Africa AJ Personnel Full time

    **Main purpose of the job**: - Project manage and support the drug development and regulatory processes workstream of the market shaping output **Location**: - **Parktown - Johannesburg** **Key performance areas**: - Project manage and support the drug development and regulatory processes workstream - Together with the senior technical specialist, work...

  • Technical Lead

    2 weeks ago

    Parktown, South Africa AJ Personnel Full time

    **Main purpose of the job**: - Lead the drug development and regulatory processes workstream for the market-shaping output **Location**: - **Parktown - Johannesburg** **Key performance areas**: - Lead the drug development & regulatory processes workstream - Work closely with CHAI and lead product development, regulatory, and quality assurance...

  • Compliance Officer

    6 days ago

    Parktown, South Africa Rand Mutual Assurance Full time

    **THE JOB AT A GLANCE** As a Compliance Officer, you will be reporting into the Compliance Manager, you will be responsible for conducting internal audits to ensure compliance with regulatory requirements and internal policies, and develop and implement compliance policies in liaison with regulators. Assess and report on compliance risks, investigate...

  • Health Market Shaping Manager

    3 weeks ago

    Parktown, South Africa AJ Personnel Full time

    **Main purpose of the job**: - Assume overall direct responsibility for the deliverable of the Market Shaping output, manage all milestones, timelines, and any emerging interdependencies - Lead the implementation of the Market Shaping working **Location**: - **Parktown - Johannesburg** **Key performance areas**: - Provide overall project leadership of...

  • Clinical Trials Manager

    7 days ago

    Parktown, South Africa AJ Personnel Full time

    **Main purpose of the job**: - Ensure compliant, timely, and cost-efficient delivery of clinical projects across a portfolio through technical input and ongoing review and evaluation of project performance, in collaboration with project teams **Location**: - **Ezintsha - 32 Princess of Wales Terrace, Parktown - Johannesburg** **Key performance...

  • Technical Lead

    2 weeks ago

    Parktown, South Africa AJ Personnel Full time

    **Main purpose of the job**: - Lead the supplier engagement and contract management workstream for the market-shaping output **Location**: - **Parktown - Johannesburg** **Key performance areas**: - Lead the supplier engagement and contract management workstream - Work closely with CHAI, and oversee the supplier management/deal negotiation process - Work...