Regulatory Pharmacist

2 weeks ago

Johannesburg, South Africa Yolundi Talent Solutions Full time

To fulfil the position as Regulatory Affairs Pharmacist for Cospharm Investments (Pty) Ltd a

Company Compliance:

- To be responsible for overall company compliance to SAPC/SAHPRA/DOH legislation.
- To ensure that the applicant operates in accordance with the provision of the Medicines and Related Substances Control Act, the Pharmacy Act and other applicable national legislation.
- To ensure compliance with all printed packaging material and promotional material.
- Responsible for SOP implementation, update and compliance.
- To ensure products released onto the market comply with approved registration dossier and quality control parameters.
- To ensure that the company is legally licenced by SAPC, DOH and SAHPRA.
- To ensure company operates in accordance with the provision of SAHPRA Section 22 C licence issued.
- To ensure the company SOP’s, Quality Manual and Site Master File are kept updated.
- To ensure processes and systems are in place for SAHPRA/SAPC inspection purposes.
- To ensure that personnel are adequately trained, and training records are available for inspection

Product Registration:
to SAHPRA.
- Response to pre-registration evaluation queries from SAHPRA.
- Responsible for variation submissions to SAHPRA.
- Responsible for renewal submissions to SAHPRA.
- 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.
- Ensuring that the company is aware of significant local regulatory issues which can

impact the business.
- Submission of dossiers/variations via Docubridge eCTD management software.

3 Documentation management:

- Managing and maintaining regulatory documentation management system.
- Ensuring regulatory compliance and quality related records are available and retained.

Documentation management:

- Managing and maintaining regulatory documentation management system.
- Ensuring regulatory compliance and quality related records are available and retained.

Pharmacovigilance:

- Responsible for Pharmacovigilance monitoring within the group.
- This involves receipt, review and response to all adverse drug reactions.

Other
- Providing status reports to the Head of Regulatory Affairs/CEO on the status of projects currently worked on.

**EDUCATION**
- Matriculation exemption.
- B.Pharm Degree.
- Must be registered with the South African Pharmacy Council (SAPC)

**EXPERIENCE**.
- Minimum 5 years experience in regulatory affairs in the South African market.

**SKILLS/PHYSICAL COMPETENCIES**
- Good understanding of Microsoft Office, Word, Excel, Powerpoint
- management skills

**BEHAVIOURAL QUALITIES**
- Takes accountability for overall company compliance - Integrity, bound to principles, confidentiality and ethics.
- Strong leadership skills.
- Good communication skills.
- Good organisational skills.
- Good planning skills.
- Good follow-up skills - Attention to detail
- Assertive.
- Conscientious.
- Patient.
- Co-operative.
- Deadline Driven

**DESIRABLE SKILLS & EXPERIENCE**:

- 5 years experience in Regulatory Affairs
- Experience in being a Responsible Pharmacist

Experience in Quality Assurance

**Salary**: From R80 000,00 per month

Application Deadline: 2024/04/06

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