Job 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.

Education:

• B. Pharm B. Pharm - Required

• M. Pharm M. Pharm - Preferred

Experience:

• 8 years or more in 8 - 10 Years

Specialized Knowledge: Licenses: