Regulatory Affairs Specialist: Pharma Compliance & PV Lead

SciGen Pte. Ltd.; Manila; On-site; PHP 600,000 - 900,000; Full time

Job summary

SciGen Pte. Ltd. is seeking a Regulatory Affairs Specialist to support registration, maintenance, and compliance of pharmaceutical products.

The role spans regulatory affairs, quality assurance, and pharmacovigilance, ensuring adherence to FDA requirements and company procedures. Responsibilities include dossier reviews, submissions, labeling checks, lifecycle management, and regulatory reporting. Strong knowledge of ICH guidelines, CTD/eCTD, and GMP is essential, along with excellent

Qualifications

• Regulatory affairs experience in pharma/biotech.
• PRC license required.
• Familiarity with ICH, CTD/eCTD, GMP and WHO guidelines.

Responsibilities

• Review regulatory dossiers and prepare product registration submissions.
• Develop and review artworks and labelling materials for regulatory compliance.
• Maintain regulatory dossiers and monitor CPR validity and renewals.
• Prepare and monitor regulatory reports and documentation for FDA and agencies.
• Coordinate with FDA and other authorities; respond to queries and deficiencies.
• Support QA and PV activities to ensure compliance.

Skills

Regulatory affairs

English fluency

Stakeholder management

Multi-project management

Education

Bachelor’s or Master’s in Pharmacy/Pharmaceutical Sciences

PRC license holder

Tools

RIMS/DMS/eCTD platforms

Regulatory submissions

Job description

SciGen Pte. Ltd. is seeking a Regulatory Affairs Specialist to support registration, maintenance, and compliance of pharmaceutical products.

The role spans regulatory affairs, quality assurance, and pharmacovigilance, ensuring adherence to FDA requirements and company procedures. Responsibilities include dossier reviews, submissions, labeling checks, lifecycle management, and regulatory reporting. Strong knowledge of ICH guidelines, CTD/eCTD, and GMP is essential, along with excellent