1) Dossier Compilation & Submission (US/EU/Canada)
- Lead compilation, review, and finalization of dossiersfor regulated markets, primarily for US (ANDA/505(b)(2) and, EUfor injectable products.
- Develop and finalize regulatory strategies for recent product development (complex injectable product).
- Coordinate with stakeholders to obtain/verify documentation required for Modules 1-3.
- Support regulatory impact assessment for CMC changes and ensure compliance with internal change control and global filing requirements.
- Author and coordinate responses to FDA/EMA deficiency letters/queries, ensuring scientifically justified, traceable, and timely responses.
- Support inspection/audit readiness(including DMF support where applicable) by ensuring traceability, data integrity, and submission correctness.
- Plan workload, mentor junior team members, and ensure high standards for document quality, formatting, and technical consistency across submissions.
- 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.