Regulatory Officer

Hammerjack Pty Ltd; Philippines; On-site; PHP 800,000 - 1,200,000; Full time

Job summary

Hammerjack Pty Ltd seeks a Regulatory Officer to manage the organization's Regulatory Affairs and Compliance function and to drive FDA compliance across all products and operations.

The role proactively identifies risks, resolves regulatory issues, and serves as the primary authority for regulatory matters, ensuring inspection-ready compliance with minimal oversight and coordinating with Quality, Operations, R&D, Marketing, and Supply Chain.

Qualifications

• Minimum 5-10 years of FDA regulatory and compliance experience.
• At least 3 years of leadership experience managing regulatory or compliance teams.
• Demonstrated experience handling FDA inspections, compliance issues, product registrations, renewals, and regulatory submissions.
• Strong network within regulatory and industry circles is highly preferred (FIXER).
• Proven track record of independently managing complex regulatory issues and achieving successful outcomes.

Responsibilities

• Act as the escalation point for complex regulatory and compliance issues
• Ensure continuous compliance with FDA regulations and other applicable government requirements
• Oversee the compliance status of all registered, applied, and marketed products
• Identify compliance risks, assess their impact, and recommend corrective and preventive actions
• Ensure all regulatory submissions, renewals, amendments, and applications are accurate and submitted within required timelines
• Provide recommendations to management regarding regulatory changes and compliance risks
• Lead investigations and resolution of regulatory issues, non-compliance findings, and product-related concerns
• Develop contingency plans and corrective actions for regulatory challenges or inspection findings
• Lead preparation activities for FDA inspections, audits, and regulatory reviews
• Represent the company during FDA inspections, inquiries, and regulatory meetings
• Collaborate with Quality, Operations, R&D, Marketing, Supply Chain, and other departments on regulatory matters
• Escalate critical compliance risks and regulatory issues to management with proposed solutions.

Skills

FDA regulations

Regulatory compliance

Leadership

Regulatory submissions

Audit readiness

Job description

Job Summary

• The Regulatory Officer is responsible in managing the organization's Regulatory Affairs and Compliance function.
• The role ensures full FDA compliance across all products and operations, drives regulatory strategies, resolves regulatory issues independently, and serves as the primary authority for regulatory matters.
• This position is expected to proactively identify risks, implement solutions, and ensure the organization remains inspection-ready compliant at all times with minimal management oversight.

Duties and Responsibilities

• Act as the escalation point for complex regulatory and compliance issues
• Ensure continuous compliance with FDA regulations and other applicable government requirements
• Oversee the compliance status of all registered, applied, and marketed products
• Identify compliance risks, assess their impact, and recommend corrective and preventive actions
• Ensure all regulatory submissions, renewals, amendments, and applications are accurate and submitted within required timelines
• Provide recommendations to management regarding regulatory changes and compliance risks
• Lead investigations and resolution of regulatory issues, non-compliance findings, and product-related concerns
• Develop contingency plans and corrective actions for regulatory challenges or inspection findings
• Lead preparation activities for FDA inspections, audits, and regulatory reviews Ensure all required documentation and records are inspection-ready at all times Represent the company during FDA inspections, inquiries, and regulatory meetings
• Collaborate with Quality, Operations, R&D, Marketing, Supply Chain, and other departments on regulatory matters
• Escalate critical compliance risks and regulatory issues to management with proposed solutions.

Qualifications

• Minimum 5-10 years of FDA regulatory and compliance experience.
• At least 3 years of leadership experience managing regulatory or compliance teams.
• Demonstrated experience handling FDA inspections, compliance issues, product registrations, renewals, and regulatory submissions.
• Strong network within regulatory and industry circles is highly preferred (FIXER).
• Proven track record of independently managing complex regulatory issues and achieving successful outcomes.

Skills and Competencies

• Highly resourceful and solutions-oriented with the ability to navigate complex regulatory challenges.
• Advanced knowledge of FDA regulations and regulatory compliance requirements.
• Regulatory risk assessment and problem-solving capability.
• Ability to work under pressure and manage multiple regulatory priorities.
• Strategic thinking and continuous improvement mindset.