Regulatory Affairs Specialist - Remote Philippines

Organon LLC; Manila; Hybrid; PHP 900,000 - 1,200,000; Full time

Benefits offered by this job

Remote work option

Job summary

Organon seeks a Regulatory Affairs Specialist to manage all regulatory submissions in the Philippines, ensuring compliance with local regulations and company standards. The role involves cross-functional collaboration to support product registrations, post-market changes, and lifecycle management.

Requires 3–5 years in regulatory affairs/CMC, and a local pharmacist registration. University degree in Health Sciences or equivalent is required.

Qualifications

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

Responsibilities

• Drive product registration plans and strategies across cross-functional teams.
• Prepare and submit new Marketing Authorization Applications to local Health Authorities.
• Maintain authorized products through timely variations, renewals, and MA supplements.
• Archive and maintain regulatory data per SOPs and local requirements.
• Ensure compliance with global/local SOPs and address deviations with CAPAs.
• Support local audits, inspections, and readiness activities.
• Develop local procedures compliant with regional/global standards and evaluate process improvements.
• Identify procedural gaps and implement collaborative solutions.
• Support drug shortage management and regulatory reporting with Quality and Supply Chain.

Skills

Regulatory affairs

CMC knowledge

Pharmacist

Regulatory processes

Communication skills

Education

Bachelor's degree in Health Sciences

Job description

Organon seeks a Regulatory Affairs Specialist to manage all regulatory submissions in the Philippines, ensuring compliance with local regulations and company standards. The role involves cross-functional collaboration to support product registrations, post-market changes, and lifecycle management.

Requires 3–5 years in regulatory affairs/CMC, and a local pharmacist registration. University degree in Health Sciences or equivalent is required.