Regulatory Affairs Specialist – Philippines

organon; Philippines; On-site; PHP 900,000 - 1,200,000; Full time

Job summary

Organon Philippines is seeking a Regulatory Specialist who will oversee submissions and lifecycle management to ensure compliance with local regulations and company standards. You will work across cross‑functional teams to drive registration strategies, coordinate post‑market dossiers, and support supply continuity while upholding regional and global SOPs.

The ideal candidate has 3–5 years in regulatory affairs/CMC, is a locally registered pharmacist, and holds a B.Sc.

Qualifications

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

Responsibilities

• Drive regulatory submissions strategies and coordinate cross‑functional execution.
• Prepare and submit new marketing authorization applications and post‑market dossiers.
• Maintain regulatory data and documentation per SOPs and local requirements.
• Ensure compliance with global/local SOPs and assist CAPA when needed.
• Support audits, inspections and readiness activities with contraction partners/vendors.
• Identify gaps and drive improvements in regulatory processes.

Skills

Regulatory affairs

CMC knowledge

Pharma industry

Education

Bachelor of Science in Health Sciences

Local registered pharmacist

Job description

Organon Philippines is seeking a Regulatory Specialist who will oversee submissions and lifecycle management to ensure compliance with local regulations and company standards. You will work across cross‑functional teams to drive registration strategies, coordinate post‑market dossiers, and support supply continuity while upholding regional and global SOPs.

The ideal candidate has 3–5 years in regulatory affairs/CMC, is a locally registered pharmacist, and holds a B.Sc.