Regulatory Affairs Manager - Emerging Markets

Job description

JOB DESCRIPTION: Regulatory Affairs – Senior Role Summary 1. Product Registrations & Submissions 2. Cross‑Functional Leadership 3. Life‑Cycle Compliance 4. Regulatory Strategy & Business Partnership 5. Continuous Improvement & Operational Excellence 6. Health Authority Engagement 7. Licensing Responsibilities - Provide high‑level regulatory leadership for global development programs and commercial products across Emerging Markets (defined as all regions except Switzerland, the United States, Europe, Canada, and Australia). - Define, drive, and optimize global regulatory strategies, ensuring full alignment with cross‑functional stakeholders. - Determine data requirements, evaluate scientific evidence against regulatory standards, and ensure robust dossier quality. - Lead the preparation, review, and approval of complex registration packages and responses to agency inquiries. - Maintain complete oversight of filings, approvals, and regulatory documentation throughout the product life cycle. - Develop strategy and briefing materials for Health Authority interactions, ensuring consistent and well‑positioned company messaging. - Represent Regulatory Affairs in senior internal forums, ar...