Key Responsibilities:

1. Regulatory Compliance - PPB & Legal

- Licensing: Ensure company, premises, and pharmacists have valid PPB licenses. Track renewals.

- Product Registration: Dossier submission, variations, renewals of all products with PPB.

- Import/Export Permits: Apply for and track permits for importation and destruction.

- Regulatory Inspections: Be the lead contact during PPB inspections. Close all audit findings on time.

- Update on Laws: Track changes in Pharmacy and Poisons Act, Cap 244, and all PPB guidelines.

2. Good Practices Oversight

- GDP - Good Distribution Practice: Ensure proper storage, stock rotation, and traceability.

- GMP oversight: Liaise with manufacturers to ensure batch records, COAs, and GMP certificates are compliant.

- Documentation: Maintain SOPs, quality manuals, and ensure staff are trained and records are audit-ready.

3. Internal Governance & Training

- Policy Development: Draft and update company compliance policies to match PPB requirements.

- Staff Training: Train sales, warehouse, and QA teams on PPB regulations, ethical marketing, and handling of poisons.

- Product Knowledge Training: Train Sales and Marketing teams to represent products correctly and ethically to HCPs.

- Compliance Monitoring: Do internal audits, regulatory and sales practices.

4. Risk & Reporting to Management/Managing Director

- Compliance Dashboard: Update MD on regulatory risks, pending PPB submissions, audit findings, and license expiry dates.

- Deviation Management: Investigate and report any regulatory deviations with corrective actions.

- Ethical Marketing: Reviewing promotional materials to ensure transparency, prevent misleading claims, and avoid off-label discussions.

Qualifications:

-Bachelor’s degree in pharmacy (B. Pharm)

-Valid practicing License

-Regulatory affairs and quality assurance added advantage.