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 me...