Regulatory Officer

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.