Regulatory Affairs Manager

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

About the role

The Regulatory Affairs Manager is responsible for ensuring that the company's products, operations, and regulatory activities comply with applicable laws, regulations, and government requirements. The role oversees regulatory submissions, product registrations, licenses, permits, renewals, and coordination with relevant regulatory agencies.

Key responsibilities

• Lead and manage 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.

About you

• Bachelor's degree in Pharmacy, Life Sciences, Healthcare, Business Administration, or a related field.
• At least 5 years of relevant experience in Regulatory Affairs, preferably within the pharmaceutical, healthcare, medical device, food, or related industry.
• Experience in product registration, licensing, permits, compliance, and regulatory submissions.
• Strong knowledge of applicable Philippine regulatory requirements and government agencies, preferably FDA Philippines and other relevant healthcare regulatory bodies.
• Experience in handling regulatory audits, inspections, and compliance activities is an advantage.
• Strong documentation, organizational, analytical, and communication skills.
• Excellent attention to detail and ability to manage multiple regulatory requirements and deadlines.
• Proficient in Microsoft Office and other documentation/reporting tools.
• Leadership and people-management skills.
• Ability to work independently and coordinate effectively with different departments.
• can start asap

Being part of our team will give you an opportunity to grow professionally, gain exposure to different areas of the business, and work with different teams. More importantly, you’ll be able to use your knowledge and skills to help and serve fellow Filipinos by providing quality healthcare support and assistance