Sr. Regulatory Affairs Manager (Pharmacist)

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

Job Responsibilities

- Serve as the company's Official Pharmacist and authorized representative for regulatory and compliance matters.

- Coordinate with the Food and Drug Administration (FDA), Intellectual Property Office (IPO), and other relevant agencies regarding product registrations, licenses, permits, trademark applications, and Halal certifications.

- Review, prepare, and evaluate regulatory documents for FDA submissions, including product registrations, renewals, LTO applications, promotional approvals, variations, and compliance requirements.

- Monitor and ensure the validity and timely renewal of all company licenses, certificates, registrations, and permits.

- Address regulatory deficiencies and product non-compliances by implementing appropriate corrective and preventive actions.

- Review and approve product labels, packaging materials, and product information to ensure compliance with applicable FDA standards.

- Monitor regulatory updates, including FDA Administrative Orders, Circulars, and other relevant government issuances, and communicate requirements to concerned departments.

- Coordinate with manufacturers regarding regulatory documentation, product requirements, and the preparation and maintenance of Product Information Files (PIF).

- Maintain and safeguard confidential regulatory documents and records.

- Provide regulatory assistance to trade accounts and address product-related compliance concerns.

- Supervise the QA Specialist and monitor the team's productivity, performance, and compliance with established quality standards.

- Oversee Quality Control activities, including product inspections, stability testing coordination, sample monitoring, and proper safekeeping of retention samples.

- Ensure compliance with product storage, labeling, packaging, and handling requirements.

- Coordinate regulatory permits for product shipments, monthly pest control services, and annual calibration of thermo-hygrometers and weighing scales.

- Monitor damaged and expired products, prepare necessary reports, and coordinate their proper disposition in accordance with company policies.

- Identify regulatory and operational risks and recommend improvements to strengthen compliance and quality management processes.

- Ensure proper implementation of company policies, procedures, and regulatory standards.

- Perform other related duties and responsibilities as may be assigned by management in support of Biocostech Philippines Corporation, its affiliates, and subsidiaries.

Qualifications

• Candidate must possess at least Bachelor’s degree in Pharmacy.
• Must be a Licensed Pharmacist.
• At least 4-5 years working experience with the regulatory affairs or experience in the related field is required for the position.
• Regulatory experienced in the food and cosmetic industry is an advantage.
• Background in QA, Production & Research & Development is also an advantage.
• Knowledgeable with the local legal and regulatory procedures, policies, and guidelines.
• Ability to collaborate effectively across departments to identify and implement compliance improvements.
• Strong analytical, organizational skills and possess a good leadership style.
• Possess excellent interpersonal skills and communication skills.
• Strong in attention to detail and accuracy.