Project Manager - Regulatory Affairs

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 Leaders.