Regulatory Affairs Manager - Emerging Markets

**Regulatory Affairs – Senior Role Summary**

**1. Product Registrations & Submissions**

+ 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.

**2. Cross‑Functional Leadershi...