Project Manager - Regulatory Affairs - Healthcare

Role and Responsibilities:

- Regulatory Submission Approval Planning, Monitoring and Control of Tasks and Milestones with Regulatory Team of EU region.

- Track and manage regional performance for EU countries ensuring adherence to Monthly and Quarterly On-Time Submission/ Approval Metrics for the Regulatory Teams of countries

- Providing Consultative guidance to EU countries in Planning and Control of On-Time License Renewals, Post Approval Changes, Regulatory Reporting and Query Handling from Drug Regulatory bodies,

- Lead Projects and Initiatives to support Country Regulatory team in Regulatory Changes

- Strategic Planning and Execution for Submission preparations, Dossier preparations, Global Trade Services (GTS) Regulatory Controls, Advertising Promotions, and publishing

- Liase with Global Regulatory Counterparts and represent in various Change Advisory Boards including Regulatory Assessment, GTS, Regulatory Systems such as Liquent Insight, Documentum, Oracle Agile, SAP Modules

- Coordinate with cross geography stakeholders from Supply Chain, Regulatory, IT Systems, etc and resolution of Sales Order, STO or Delivery Blocks

- Work with Local and Regional Project Teams to identify Process Inefficiencies and work towards Continuous Improvement of processes, workflows etc.

- Regulatory Operations Health and KPI Monitoring, Information Management and Analytics.

- Weekly and Monthly Dashboard Management on Business Intelligence Tools such as MS Power BI for QRA and Monthly/ Quarterly Org Health Report Development for Country Business Leader