Job Purpose:

The Pharmacist is responsible for ensuring full compliance of Organica’s products and operations with FDA, DOH, and other relevant regulations. This role covers both regulatory affairs—including product registrations, permits, and audits—and operational compliance, such as Good Distribution Practice (GDP), Good Manufacturing Practice (GMP), and quality assurance. The Pharmacist serves as a key liaison with regulatory authorities and supports the business in maintaining product integrity, consumer safety, and regulatory readiness.

Key Responsibilities:

1.Regulatory Affairs

• Prepare, review, and submit product registration dossiers for pharmaceuticals, food supplements, cosmetics, and medical devices.
• Monitor, track, and ensure timely renewal of FDA registrations, licenses, and permits (e.g., LTO, CPR, CPRR).
• Maintain up-to-date knowledge of FDA, DOH, and other regulatory requirements; communicate regulatory changes to management and relevant teams.
• Liaise with FDA and other regulatory authorities during inspections, audits, and product-related queries.
• Review and approve product labels, packaging, and promotional materials to ensure regulatory compliance.

2. Operational Compliance & Quality

• Oversee product receipt, storage, and distribution in line with Good Distribution Practice (GDP).
• Ensure proper inventory management systems are in place, including batch traceability and documentation.
• Assist in quality assurance and control activities such as deviation reports, corrective and preventive actions (CAPA), and incident investigations.
• Support manufacturing and production teams to maintain adherence to Good Manufacturing Practices (GMP).
• Participate in internal audits, supplier audits, and compliance checks, ensuring timely closure of audit findings.

3. Training & Team Support

• Conduct training sessions and awareness programs for staff on regulatory requirements and compliance best practices.
• Foster a compliance-focused culture across cross-functional teams by promoting awareness and accountability

4. Documentation & Reporting

• Maintain accurate, updated regulatory and operational compliance records, ensuring audit readiness at all times.
• Prepare regulatory and compliance reports for management review.
• Ensure timely escalation of risks, issues, or non-compliance events, along with proposed corrective actions.

Perform additional tasks or projects as assigned by management.

Job Requirements:

• Education: Licensed Pharmacist; Bachelor of Science in Pharmacy required.
• Experience: Minimum 2–4 years of experience in regulatory affairs, quality assurance, or compliance within the pharmaceutical, food supplement, cosmetics, or medical device industry.
• Experience preparing FDA dossiers, handling renewals, and liaising with regulatory authorities strongly preferred.
• Familiarity with GMP, GDP, and other industry standards.