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 current 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 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.

Education:

- B. Pharm B. Pharm - Required

- M. Pharm M. Pharm - Preferred

Experience:

- 8 years or more in 8 - 10 Years

Specialized Knowledge: Licenses:

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