Regulatory Affairs Manager

Regulatory Strategy & Submissions

• Develop and implement regulatory strategies to support product registration, label updates, lifecycle management, and market expansion activities.
• Lead the preparation, review, and submission of regulatory dossiers to health authorities across multiple regions.
• Ensure submissions comply with applicable regulations, guidelines, and industry standards.
• Manage regulatory timelines to support product approvals, launches, and business objectives.

Health Authority Engagement

• Serve as the primary regulatory contact for interactions with regulatory agencies.
• Coordinate responses to authority questions, deficiency letters, and information requests.
• Support regulatory inspections, audits, and compliance activities.

Lifecycle Management

• Oversee post-approval regulatory activities, including variations, renewals, labelling updates, and product maintenance.
• Monitor and assess the impact of emerging regulations and evolving requirements on existing products.
• Provide strategic recommendations to mitigate regulatory risks.

Cross-Functional Collaboration

• Partner with Clinical Development, Medical Affairs, Pharmacovigilance, Quality Assurance, Manufacturing, Supply Chain, and Commercial teams.
• Provide regulatory guidance throughout the product development and commercialisation lifecycle.
• Contribute to launch readiness planning and market expansion initiatives.

Compliance & Governance

• Ensure regulatory processes and documentation are maintained in accordance with relevant regulations and company policies.
• Support the development and continuous improvement of regulatory systems, processes, and procedures.
• Maintain awareness of industry best practices and regulatory intelligence.