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Regulatory Pharmacist

3 months ago

Johannesburg, Gauteng, 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 preregistration evaluation queries from SAHPRA.
  • Responsible for variation submissions to SAHPRA.
  • Responsible for renewal submissions to SAHPRA.
  • Ensure ongoing 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 followup skills
  • Attention to detail
  • Assertive.
  • Conscientious.
  • Patient.
  • Cooperative.
  • 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