Regulatory Affairs and Responsible Pharmacist

SUMMARY:
To fulfil the position as Regulatory Affairs/Responsible Pharmacist for the company in South Africa.

POSITION INFO:

1 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 of all printed packaging material and promotional material.

• Responsible for the company’s Quality Management System; SOP implementation, update and compliance.

• Coordinating with approved local laboratories for Post Importation Testing of all product shipments.

• Responsible for batch release for all products

• To ensure products released onto the market comply with approved registration dossier and quality control parameters.

• To ensure that the company is legally licensed by SAPC, DOH and SAHPRA.

• To ensure company operates in accordance with the provision of SAHPRA Section 22 C license 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.

• To ensure batch manufacturing and master documentation review and approval prior to production taking place.

2 Product Registration:

• Responsible for screening, compilation and submission of new registration applications to SAHPRA.

• Continuous engagement with company partners during and after product registration.

• Response for resolution of 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.

4 Pharmacovigilance:

• Responsible for Pharmacovigilance monitoring within the group.

• This involves receipt, review and response to all adverse drug reactions.

5 Other:

• Providing weekly status reports to CBDO/CEO on the status of projects currently worked on.

Minimum Requirements:

Behaviourial 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 and experience:

• B Pharm degree
• 5 years’ experience in Regulatory Affairs
• Experience in being a Responsible Pharmacist
• Experience in Quality Assurance