Manager - RA

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Date: Mar 27, 2025

Location: Airoli, MH, IN

Company: Lupin

Long Description

- Preparation of dossiers for Europe, Australia, New Zealand, and Canada (EANC). - Responding to queries from regulatory agencies of EANC advanced markets and customers. - Liaising with R&D, manufacturing plants, clinical teams, and respective EANC offices/BD teams. - Assisting in the life cycle management of EANC-registered products by obtaining variation approvals. - Maintenance of departmental databases. - Regular study of regulatory guidelines and electronic Common Technical Document (eCTD).

Competencies

Customer Centricity
Developing Talent
Collaboration
Strategic Agility
Process Excellence
Stakeholder Management
Innovation & Creativity
Result Orientation

Education

Masters in Biochemistry

Work Experience

2 years experience in RA

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