Global Regulatory Affairs & QA Specialist

SciGen Pte. Ltd.; Manila; On-site; PHP 600,000 - 1,000,000; Full time

Job summary

SciGen Pte. Ltd. is seeking a Regulatory Affairs Specialist in Manila to support product registrations, labeling, and lifecycle management in compliance with FDA requirements.

You will collaborate with QA and PV teams, manage regulatory submissions, and liaise with government agencies to ensure timely approvals and ongoing compliance. The role requires 3–5 years in PH Regulatory Affairs, a PRC license, and strong knowledge of ICH, CTD/eCTD, GMP, and local regulations.

Qualifications

• Bachelor's or master's degree in Pharmacy, Pharmaceutical Sciences, Life Sciences or related field.
• Preferred to be a PRC-licensed pharmacist for regulatory affairs roles.
• 3–5 years of PH Regulatory Affairs experience in pharma/biotech, with at least 1 year end-to-end drug registration exposure.
• Strong knowledge of ICH guidelines, CTD/eCTD, PIC/S GMP, WHO guidelines, and local frameworks.
• Excellent communication, negotiation, and stakeholder management skills.

Responsibilities

• Review regulatory dossiers and prepare/submit product registration applications; develop and review artwork and labeling; manage foreign GMP clearances.
• Support lifecycle management: renewals, variations, and post-approval changes; ensure labeling aligns with FDA-approved documents; review packaging materials and promotional content.
• Prepare, submit, and monitor FDA and government agency reports; ensure proper maintenance of regulatory documents; coordinate supporting documents for regulatory and bidding needs.
• Serve as liaison with FDA and other government agencies; respond to regulatory queries and deficiency letters; assist in inspections and audits.

Skills

Regulatory affairs

Pharmacovigilance

Quality Assurance

Cross-functional coordination

Education

Bachelor's or master's in Pharmacy/Pharmaceutical Sciences/Life Sciences

PRC license holder

Tools

Microsoft Office

RIMS/DMS/eCTD platforms

Job description

SciGen Pte. Ltd. is seeking a Regulatory Affairs Specialist in Manila to support product registrations, labeling, and lifecycle management in compliance with FDA requirements.

You will collaborate with QA and PV teams, manage regulatory submissions, and liaise with government agencies to ensure timely approvals and ongoing compliance. The role requires 3–5 years in PH Regulatory Affairs, a PRC license, and strong knowledge of ICH, CTD/eCTD, GMP, and local regulations.