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Job Details

Responsibilities

Regulatory Lifecycle Strategy & Hub Delivery Leadership
Develop and execute regulatory execution strategies for lifecycle maintenance activities across European (EU and non‑EU) countries within a Hub operating model, maximizing Hub-delivered work and minimizing local execution where feasible.
Lead end-to-end coordination of post-approval maintenance activities, including (as applicable) variations, renewals, notifications/administrative changes, labeling/PI updates, post-approval commitments, line extensions, and country-specific maintenance requirements.
Translate global strategy into country action plans: define scope, timelines, dependencies, stakeholders,



and deliverables; maintain robust trackers and ensure “no-surprise” execution.
Anticipate regulatory and operational risks (e.g., missing inputs, data gaps, conflicting country expectations, dependency delays), propose mitigation plans, and support timely decision-making.
Coordinate preparation, review, and submission readiness of required documentation (e.g., Module 1 country components and relevant CTD/eCTD content as needed), ensuring alignment with core dossiers and company standards.
Lead responses coordination to regulatory authority questions, deficiency letters, and compliance requests for assigned markets, ensuring timely input collection, quality review, and on-time dispatch.
Coordinate EU PI / labeling updates and drive alignment/harmonization with local labels (where in scope), ensuring timely implementation and traceable decision logs.
Regulatory Compliance, Planning Discipline & Intelligence Ap

📌 Senior Manager, EU Hub (Noida)
🏢 Pharmalex
📍 Noida