Deputy Manager, Regulatory Affairs
Amneal Pharmaceuticals
- Location
- Ahmedabad, Gujarat, India
- Job type
- Full-time
About the role
Amneal Pharmaceuticals
Website:
amneal.com
Job details:
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 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 - Required
- M. Pharm M. Pharm - Preferred
Experience:
- 8 years or more in 8 - 10 Years
Specialized Knowledge: Licenses:
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