Regulatory Pharmacist

1 week ago

Makati City, National Capital Region, Philippines Go Rocky Full time

The Regulatory Pharmacist ensures compliance with all pharmaceutical and regulatory standards, with a particular focus on compounding pharmacy operations. This role will manage regulatory submissions, maintain licensing requirements, and oversee the compounding pharmacy once it is established. The Regulatory Pharmacist will provide guidance on product development, quality assurance, and ensure adherence to DOH, FDA, and PRC regulations.

Arrangement: Full-Time - Mon-Fri; Hybrid- Makati - Compliance Department

What You'll Do:

Regulatory Compliance

● Ensure company and product compliance with all applicable regulations from FDA, DOH, PDEA, PRC, and other governing bodies.

● Maintain valid licenses, permits, and certificates for pharmacy operations, compounding facilities, and products.

● Monitor and interpret regulatory updates and communicate requirements to internal teams.

Compounding Pharmacy Management

● Lead the planning, setup, and operation of the compounding pharmacy.

● Develop policies, procedures, and standard operating protocols for compounding activities.

● Ensure the pharmacy complies with GMP, DOH, and PRC standards for compounding.

● Supervise pharmacy staff and manage operational workflow once the compounding pharmacy is active.

Documentation & Submissions

● Prepare, review, and submit regulatory documents such as product registration, renewals, variations, and amendments.

● Maintain audit-ready regulatory documentation, including compounding records.

● Review labels, product claims, and marketing materials to ensure compliance.

Product Lifecycle & Quality

● Support R&D and product development with regulatory guidance, particularly for custom formulations and compounded medications.

● Review quality-related documentation, batch records, and Certificates of Analysis (COAs).

● Participate in audits, inspections, and implement corrective actions as needed.

Coordination & Stakeholder Management

● Liaise with government agencies, suppliers, and partners for regulatory submissions and compliance.

● Work closely with cross-functional teams including Operations, Product, Marketing, and Legal.

What We're Looking For:

● Licensed Pharmacist (PRC) in good standing.

● Must have experience in managing a compounding pharmacy (setup, operations, or oversight).

● Strong understanding of DOH, FDA, PRC regulations, and GMP/GDP standards.

● Experience with regulatory submissions, product registration, and compliance audits.

● Excellent documentation, communication, and stakeholder management skills.

● Experience in pharmaceuticals, compounding, medical devices, or healthcare startups preferred.

What We Offer:

● Collaborative, passionate and supportive team

● Competitive salary and benefits

● Flexible work arrangements

● Hybrid (occasional travel may be required for regulatory inspections or submissions)

Job Type: Full-time

Pay: Php90, Php150,000.00 per month

Benefits:

  • Flexible schedule
  • Flextime

Work Location: Hybrid remote in Makati City

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