Primary Responsibilities (Key Accountabilities)

1) 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.

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 robust document control, version governance, and cross‑functional
document alignment.
* Monitor regulatory intelligence and imp

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