Deputy Manager, Regulatory AffairsAmneal Pharmaceuticalsfull-timeRequired skillscomplianceAbout the role Amneal Pharmaceuticals Website: amneal.com Job details: Job DescriptionPrimary 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 InterpretationMaintain 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 changesProvide input to regulatory strategy and risk assessments based on evolving regulatory expectations and trends.Essential FunctionsLead 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 approvalsEnsure 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 QUALIFICATIONS B. Pharm B. Pharm - RequiredM. Pharm M. Pharm - PreferredExperience:8 years or more in 8 - 10 YearsSpecialized Knowledge: Licenses: Click on Apply to know more. This page is fully interactive when JavaScript is enabled. Please enable JavaScript to apply or browse related roles.