Job Description
Job Description
We are looking for a Regulatory Affairs Specialist – Global Lifecycle Management (LCM) to support and manage post‑approval regulatory activities across global markets, ensuring compliance and timely maintenance of product licenses.
This role is pivotal in managing activities related to global lifecycle submissions, including variations, renewals, label updates, artwork changes, CMC updates, site transfers, and administrative maintenance. Collaboration with global Health Authorities, manufacturing sites, and internal cross‑functional teams will be essential to ensure continuous regulatory compliance of marketed products.
Roles & Responsibilities
- Should have regulatory experience in lifecycle management activities for multiple markets especially in Europe
- Preparation, review, and submission of variations (Type IA/IB/II), renewals, notifications, and a...