Pharmacy & Regulatory Affairs Incharge

To ensure regulatory compliance, pharmaceutical quality assurance, and uninterrupted availability of medicines across SHINE Humanity clinics in alignment with DRAP, SHCC & KPHCC regulations, organizational SOPs, and donor requirements. The individual must be a Pharm-D and must be willing to provide their license for organizational use.

Key Roles & Responsibilities

• Lead and manage DRAP and SHCC compliance and oversee all pharmaceutical regulatory affairs, ensuring alignment with donor, audit, and statutory requirements.
• Ensure all medicines meet quality, safety, efficacy, labeling, storage, and distribution standards in accordance with DRAP regulations, WHO guidelines, SHCC and KPHCC.
• Develop, review, implement, and enforce pharmacy SOPs, policies, and guidelines aligned with Good Pharmacy Practices (GPP) and Good Storage Practices (GSP).
• Ensure comprehensive quality assurance of pharmacy operations at both clinic level and the central warehouse.
• Support donor and management reporting through regular medicine consumption analysis, stock monitoring, and QA documentation.
• Review doctors’ SOAP notes to promote rational prescribing, clinical appropriateness, and compliance with treatment protocols.
• Conduct medicine utilization reviews and trend analyses to support evidence-based decision-making and cost-effective use of medicines.
• Conduct drug research and recommend evidence-based additions, deletions, or revisions to the SHINE drug formulary.
• Identify, evaluate, and liaise with pharmaceutical companies to support procurement, quality sourcing, and strategic partnerships.
• Strengthen staff capacity through structured training, supervision, mentoring, and performance monitoring, ensuring dispensers adhere to SOPs and regulatory standards.
• Review & share clinic-wise medicine demands, responsible for clinic inter transfer and coordinate closely with Inventory and Warehouse teams to ensure timely replenishment.
• Ensure uninterrupted availability of essential medicines and maintain zero stock-outs at all service delivery points.

Job Type: Full-time

Pay: Rs90,000.00 - Rs130,000.00 per month

Work Location: In person