Senior Regulatory Affairs Leader — Pharma Compliance & QA

Biocostech Philippines Corporation; Mandaluyong; On-site; PHP 900,000 - 1,700,000; Full time

Benefits offered by this job

Job summary

Biocostech Philippines Corporation invites applications for the Official Pharmacist role to lead regulatory affairs in Metro Manila. You will coordinate with FDA and other agencies for registrations, licenses, and labeling compliance while supervising QA activities and ensuring product information remains current and compliant.

The position requires a licensed pharmacist with 4–5 years in regulatory affairs, preferably with food/cosmetics exposure, and strong leadership, analytical, and

Qualifications

• Bachelor’s degree in Pharmacy and licensed pharmacist.
• 4–5 years in regulatory affairs.
• Regulatory experience in food/cosmetics is a plus.
• Background in QA, Production & R&D is an advantage.
• Knowledge of local regulatory procedures and guidelines.
• Strong leadership and cross‑department collaboration.
• Excellent attention to detail and communication skills.

Responsibilities

• Serve as Official Pharmacist and regulatory liaison for compliance.
• Coordinate with FDA, IPO and agencies on registrations.
• Prepare and review FDA submissions, renewals, and permits.
• Monitor licenses, certificates, registrations and permits for timely renewal.
• Address regulatory deficiencies with corrective actions.
• Review labels and packaging for FDA compliance.
• Monitor regulatory updates and communicate requirements.
• Coordinate with manufacturers on regulatory docs and Product Information Files (PIF).
• Safeguard confidential regulatory documents and records.
• Provide regulatory assistance to trade accounts for compliance concerns.
• Supervise QA Specialist and monitor team performance and quality standards.
• Oversee QA activities: inspections, stability testing, retention samples.
• Ensure proper storage, labeling, packing and handling requirements.
• Coordinate permits for shipments, pest control, and calibration.
• Monitor damaged/expired products and coordinate disposition.
• Identify regulatory and operational risks and propose improvements.
• Ensure implementation of company policies and regulatory standards.
• Perform other duties as assigned by management.

Skills

Regulatory affairs knowledge

Leadership

Analytical skills

Attention to detail

Interpersonal communication

Education

Bachelor’s degree in Pharmacy

Job description

Biocostech Philippines Corporation invites applications for the Official Pharmacist role to lead regulatory affairs in Metro Manila. You will coordinate with FDA and other agencies for registrations, licenses, and labeling compliance while supervising QA activities and ensuring product information remains current and compliant.

The position requires a licensed pharmacist with 4–5 years in regulatory affairs, preferably with food/cosmetics exposure, and strong leadership, analytical, and