Regulatory Affairs Consultant (Global Submission Coordinator - EU and US)

Global Regulatory Affairs Consultant responsible for coordinating regulatory submissions across EU and US. Manage preparation, compilation, and submission of new drug applications and lifecycle management activities; collaborate with Regional Submission Coordinators and SMEs to ensure complete documentation and timely readiness. Develop Submission Content Plans (SCP) aligned with country-specific requirements, draft M1 documents, support labeling and artwork change controls, and upload submissions to archiving systems. Maintain Veeva records, track questions from Health Authorities, and ensure clear communication among CMC, labeling, RRL, LRR, and RPR. Requires strong project management, regulatory submission experience, and proficiency in regulatory tracking systems and MS Office; fluent in English.