Regulatory Pharmacist

RCX RECRUITMENT INC.; Metro Manila; On-site; PHP 420,000 - 660,000; Full time

Benefits offered by this job

SSS/PhilHealth/Pag-IBIG

13th-month pay

HMO coverage

Performance bonus

Job summary

RCX RECRUITMENT INC. in Metro Manila is seeking a Regulatory Affairs Pharmacist to manage CPR filings, LTO renewals, and regulatory documentation. You will review labeling and packaging for FDA compliance and coordinate official regulatory activities with the government.

The role requires a licensed pharmacist with PRC and 1–2 years in regulatory affairs, plus strong English and meticulous organization to support audits and payments.

Qualifications

• Registered/Licensed Pharmacist in the Philippines with a valid PRC License.
• Minimum of 1-2 years of proven experience in Regulatory Affairs within the pharmaceutical or healthcare sector.
• Exceptional organizational, administrative, and document control skills with high attention to detail.
• Business-level English.

Responsibilities

• Manage end-to-end CPR applications with the Philippine FDA; prepare, submit and track filings.
• Maintain and renew the company's License to Operate (LTO) and act as primary contact for regulatory correspondence.
• Review packaging, labeling and promotional artwork for compliance with local FDA guidelines and company standards.
• Maintain regulatory document archives, monitor renewal timelines, coordinate notarization, apostilles and official payments.
• Process government invoice payments, organize regulatory files, and support external audits.

Skills

Regulatory affairs

Documentation & record-keeping

English communication

Organization & attention to detail

Education

Licensed Pharmacist in the Philippines (PRC)

Tools

Philippine FDA portal

Job description

Key Responsibilities

• FDA Product Registration: Manage the end-to-end preparation, submission, and tracking of Certificate of Product Registration (CPR) applications with the Philippine FDA.

• Licensing & Government Relations: Maintain and renew the company's License to Operate (LTO) and serve as the primary contact for official regulatory correspondence.

• Labeling & Material Review: Review product packaging, labeling, and promotional artwork to ensure strict compliance with local FDA guidelines and global company standards.

• Compliance & Archiving: Maintain systematic regulatory document archives, monitor renewal timelines, and coordinate legal requirements (notarization, apostilles, and official payments).

• Administrative & Audit Support: Process government invoice payments, organize regulatory files, and ensure document readiness for external audits.

Requirements

Must-Have:

• Registered/Licensed Pharmacist in the Philippines with a valid PRC License.

• Minimum of 1-2 years of proven experience in Regulatory Affairs within the pharmaceutical or healthcare sector.

• Exceptional organizational, administrative, and document control skills with high attention to detail.

• Business-level English.

Nice-to-Have:

• In-depth working knowledge of Philippine FDA regulations, portal systems, and filing procedures.

Benefits & Perks

• Complete Philippine Statutory Benefits (SSS, PhilHealth, Pag-IBIG, 13th-Month Pay)

• Comprehensive HMO Coverage

• Performance-Based Company Bonus