Regulatory Affairs Lead — Submissions & Compliance (PH)

1Life Inc.; Quezon City; On-site; PHP 900,000 - 1,500,000; Full time

Job summary

1Life Inc. is seeking a Regulatory Affairs Manager to ensure our products, operations, and regulatory activities comply with Philippine laws and government requirements.

You will lead regulatory submissions, licensing, renewals, and coordinate with agencies, while guiding internal teams on compliance and documenting all regulatory activities. The role requires an analytical mindset, attention to detail, and ability to manage multiple deadlines, with availability to start ASAP.

Qualifications

• Bachelor's degree in Pharmacy, Life Sciences, Healthcare, Business Administration, or a related field.
• At least 5 years of regulatory affairs experience in pharma/healthcare or related industry.
• Experience with product registrations, licensing, permits, and submissions.
• Strong knowledge of Philippine regulatory requirements and agencies (FDA Philippines).
• Experience in audits and regulatory inspections is an advantage.
• Excellent documentation, organizational and communication skills.

Responsibilities

• Lead regulatory affairs activities, including product registration, licensing, renewals, and regulatory submissions.
• Prepare, review, and ensure completeness and accuracy of regulatory documents and applications.
• Monitor changes in laws, regulations, guidelines, and government requirements that may affect the company and its products.
• Ensure timely submission and renewal of permits, licenses, certificates, registrations, and other regulatory requirements.
• Coordinate and communicate with regulatory agencies and government offices regarding applications, compliance requirements, inspections, and regulatory concerns.
• Maintain accurate and updated records of all regulatory documents, submissions, approvals, and licenses.
• Review product labels, packaging, promotional materials, and other documents for regulatory compliance.
• Provide regulatory guidance to internal departments regarding product development, operations, marketing, and business activities.
• Identify potential regulatory risks and recommend appropriate corrective or preventive actions.
• Support regulatory inspections, audits, and inquiries and ensure timely resolution of findings or deficiencies.

Job description

1Life Inc. is seeking a Regulatory Affairs Manager to ensure our products, operations, and regulatory activities comply with Philippine laws and government requirements.

You will lead regulatory submissions, licensing, renewals, and coordinate with agencies, while guiding internal teams on compliance and documenting all regulatory activities. The role requires an analytical mindset, attention to detail, and ability to manage multiple deadlines, with availability to start ASAP.