1. Regulatory Submissions and Filings

• Prepare and submit regulatory documents for product registration, renewals, variations, and licensing as required by the FDA Philippines and other regulatory agencies.

2. Regulatory Compliance and Guidance

• Provide regulatory guidance to cross-functional teams (e.g., R&D, QC, manufacturing) to ensure products and processes comply with Philippine regulatory requirements.
• Review product labels, advertisements, and promotional materials for regulatory compliance.
• Monitor and interpret changes in Philippine regulatory laws, standards, and guidelines, and communicate updates to relevant stakeholders.

3. Communication with Regulatory Authorities

• Serve as the point of contact between the company and regulatory bodies such as FDA Philippines, DOH, and other local agencies.
• Prepare and submit responses to regulatory queries, deficiencies, and requests for additional information.
• Support regulatory inspections and audits, including the preparation of documentation and onsite coordination.

4. Post-Market Surveillance and Compliance

• Participate in post-market activities including monitoring for adverse events, safety reporting, and regulatory updates.
• Coordinate and submit Adverse Event Reports (AERs), Periodic Safety Update Reports (PSURs), and other post-approval documentation.
• Support product recall activities in compliance with FDA Philippines requirements.

5. Documentation and Record Keeping

• Maintain up-to-date records of all regulatory submissions, approvals, and correspondences.
• Ensure regulatory documentation is audit-ready and stored according to compliance and company policies.
• Keep a detailed log of all interactions and communications with regulatory authorities.

6. Market Intelligence and Regulatory Research

• Continuously monitor the local regulatory landscape, including emerging regulations, policies, and enforcement trends.
• Conduct regulatory assessments for new product introductions or market expansions.
• Provide recommendations based on current and anticipated regulatory requirements.

7. Cross-functional Collaboration

• Work closely with internal teams including Legal, Marketing, R&D, QA/QC, and Manufacturing to ensure regulatory considerations are integrated throughout the product lifecycle.
• Contribute to the development of regulatory strategies for new and existing products, starting from early development through commercialization.
• Ensure completeness, accuracy, and timeliness of regulatory dossiers and filings.
• Track submission timelines and monitor the progress of applications to ensure timely approvals.

• Bachelor’s degree in Pharmacy, Life Sciences, Chemistry, Biology, or a related field.
• Additional certifications or courses in Regulatory Affairs or Compliance are a plus (e.g., Regulatory Affairs Certification - RAC).
• 1–2 years of experience in regulatory affairs, quality assurance, or a similar role within the pharmaceutical, medical device, or consumer goods industry in the Philippines.
• Experience with FDA Philippines regulations, product registration, and approval processes is strongly preferred.