Primary Responsibilities (Key Accountabilities)
1) Dossier Compilation & Submission (US/EU/Canada)
2) Regulatory Intelligence & Guidance Interpretation
- Maintain up‑to‑date knowledge of FDA guidance , ICH guidelines , EU requirements, and relevant public domain information; assess impact on ongoing and future submissions and translate updates into actionable changes
- Provide input to regulatory strategy and risk assessments based on evolving regulatory expectations and trends.
Essential Functions
- Lead and manage regulatory workload planning, prioritization, and performance delivery for regulated market programs.
- Drive dossier compilation for complex injectable products/high‑impact submissions and ensure first cycle approvals
- Ensure strong document control, version governance, and cross‑functional document alignment.
- Monitor regulatory intelligence and implement necessary updates into strategies and documentation standards.
- Lead CFT communications (queries, commitments, and follow‑ups) and maintain submission traceability.
- Apply risk identification and mitigation across regulatory programs to reduce approval delays.
