Deputy Manager, Regulatory Affairs at Amneal India

Ahmedabad, gujarat, India -

Full Time

Start Date

Immediate

Expiry Date

17 Aug, 26

Salary

0.0

Posted On

19 May, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Dossier Compilation, Regulatory Strategy, 505(b)(2) Applications, ANDA, CMC Changes, FDA Guidance, ICH Guidelines, EMA Deficiency Responses, Complex Injectables, Regulatory Intelligence, Document Control, Risk Mitigation

Industry

Pharmaceutical Manufacturing

Description

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 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.

Responsibilities

Lead the compilation and submission of regulatory dossiers for injectable products in US, EU, and Canadian markets. Manage regulatory strategies, author responses to health authority queries, and ensure compliance with global filing requirements.