Regulatory Affairs Manager

About the role

The Regulatory Affairs Manager works closely with the Head of Regulatory Affairs to oversee all regulatory matters across the organization. This position ensures that licensing, filings, certifications, and permits are processed accurately and on time while anticipating regulatory changes that could impact products, operations, or testing requirements.

Key responsibilities

• Stay updated on regulatory changes and align company policies and procedures accordingly.
• Assist internal committees on legal and regulatory updates.
• Develop and maintain compliance policies reflecting current regulations and best practices.
• Oversee preparation and timely submission of regulatory documents to authorities.
• Implement monitoring systems, conduct audits, and produce regular compliance reports for senior management.
• Analyze compliance data to identify trends, risks, and mitigation strategies.
• Coordinate with legal, finance, operations, and IT departments to ensure a unified compliance approach.
• Serve as primary liaison with regulatory authorities and industry bodies.
• Investigate non‑compliance incidents, determine root causes, and lead corrective actions.
• Manage crisis response during regulatory investigations or audits and drive continuous improvement.

Required profile

• Strong understanding of regulatory frameworks and compliance processes.
• Excellent analytical and problem‑solving abilities.
• Proactive mindset with the ability to anticipate regulatory shifts.
• Effective communication skills for internal coordination and external liaison.
• Experience in preparing and managing regulatory submissions.

Required skills

• Regulatory compliance knowledge
• Policy development
• Data analysis
• Audit and monitoring systems
• Stakeholder coordination