Remote Regulatory Affairs Specialist — Philippines

Organon; United States; Remote; USD 90,000 - 130,000; Full time

Job summary

Organon is seeking a Regulatory Specialist to manage submissions and lifecycle activities for the Philippines market, collaborating with cross-functional teams to ensure compliance with local regulations and global standards.

The role involves preparing MAAs, variations, renewals, and labeling support, while maintaining regulatory data and supporting audits and CAPA processes. A licensed pharmacist with 3–5 years of regulatory experience is required.

Qualifications

• 3–5 years of regulatory affairs and/or CMC experience in an MNC or local market.
• Local registered pharmacist is required.
• Expert knowledge of local regulatory processes and activities.
• University degree in Health Sciences (or equivalent).

Responsibilities

• Drive product registration plans and cross-functional communication to execute strategy.
• Prepare and submit MAAs and post-market regulatory dossiers per local regulations.
• Archive regulatory data per policies and local requirements.
• Ensure SOP compliance and drive CAPAs for non-conformities locally.
• Support local audits, inspections, and readiness activities.
• Develop local procedures to improve efficiency and processes.
• Identify procedural gaps and implement solutions with stakeholders.
• Support drug shortage management and regulatory reporting with Quality and Supply Chain.

Skills

Regulatory affairs

CMC

Licensed pharmacist

Education

Bachelor’s degree in Health Sciences

Licensed pharmacist

Job description

Organon is seeking a Regulatory Specialist to manage submissions and lifecycle activities for the Philippines market, collaborating with cross-functional teams to ensure compliance with local regulations and global standards.

The role involves preparing MAAs, variations, renewals, and labeling support, while maintaining regulatory data and supporting audits and CAPA processes. A licensed pharmacist with 3–5 years of regulatory experience is required.