RegulatoryAffairsManager

**Job title: Regulatory Affairs Manager** **Introduction to role:** Are you ready to turn complex global regulations into faster approvals that put life-changing medicines in patients’ hands? In this role, you will lead regulatory strategy and execution across development and lifecycle, guiding submissions and health authority interactions to secure timely registrations. You will translate evolving requirements into decisive plans that align teams, reduce risk, and enable confident, on-time delivery. Can you see yourself shaping the path from first dossier outline to final approval while building capability around you? **Accountabilities:** * **Regulatory Strategy:** Develop and implement regulatory strategies for product registration, labeling, post-approval changes, and lifecycle management to accelerate approvals and optimize product value. * **Submission Management:** Lead or coordinate the preparation, review, and submission of regulatory dossiers, variations, renewals, and responses to questions, delivering right-first-time quality and region-specific compliance. * **Health Authority Engagement:** Plan, support, or lead agency communications, including meeting requests, briefing documents, and rapid, clear responses and follow-up that build credibility and trust. * **Compliance and Standards:** Ensure all activities align with regulations, guidance, company policies, and submission standards; champion inspection readiness and a culture of quality. * **Cross-Functional Collaboration:** Partner with internal teams to gather required documentation, align regulatory plans with project milestones, and resolve issues quickly to protect timelines. * **Labeling Support:** Contribute to the development, review, and maintenance of product labeling, artwork, and regulatory text to ensure accuracy and alignment with scientific and commercial objectives. * **Change Control and Lifecycle Management:** Assess regulatory impact of manufacturing, quality, safety, or labeling c