Job Description
Primary Responsibilities (Key Accountabilities)
- Dossier Compilation & Submission (US/EU/Canada)
- Lead compilation, review, and finalization of dossiers for regulated markets, primarily for US (ANDA/505(b)(2) and, EU for injectable products.
- Develop and finalize regulatory strategies for new product development (complex injectable product).
- Coordinate with stakeholders to obtain/verify documentation required for Modules 1–3.
- Provide hands‑on leadership for 505(b)(2) application strategy, including identification of reliance approach, bridging requirements, PIND meeting submissions and NDA positioning to support approval.
- 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.
- 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 robust document control, version governance, and cross‑functional document alignment.
- Monitor regulatory intelligence

📌 Deputy Manager, Regulatory Affairs (Ahmedabad)
🏢 Amneal Pharmaceuticals
📍 Ahmedabad