Lead RA

**Key Areas of Responsibility:**

+ **Translates regulatory intelligence into actionable local, regional, and global regulatory strategies** aligned with business goals. **Anticipates regulatory risks and emerging issues** , offering proactive, solutions‑oriented guidance throughout the product lifecycle. **Evaluates products for classification, jurisdiction, and market‑access requirements** , identifying the most efficient regulatory pathways. **Provides technical regulatory input** across quality, preclinical, clinical, and manufacturing teams to ensure compliance. **Leads regulatory submissions end‑to‑end** —planning, preparing, submitting, and managing interactions with global health authorities. **Reviews scientific documentation** (quality, preclinical, clinical) for completeness, accuracy, and regulatory acceptability. **Collaborates effectively with cross-functional teams** , supporting meetings with regulatory authorities and advisory committees. **Develops and enh...