Regulatory Affairs - Project Management

MAJOR RESPONSIBILITIES:

• End to end project management.

• Project Coordination with internal and external stakeholders.
• Attend and lead project meetings and related coordination.
• Preparation and tracking project trackers.
• Preparation of cost proposal, tracking milestones and financials of the project.
• Review of Agreements related to the project.
• Responsible for preparation and compilation / review of registration dossiers as per current regulatory requirements of Russia CIS, EU region to obtain the necessary authorization.
• Maintain awareness and knowledge of current regulatory guidelines/legislation and ensures best regulatory practice all time.
• Provides regulatory guidance to internal stakeholders, to allow them to make key decisions on business-critical activities and project feasibility.
• Review, analyse and prepare/compile documents generated by R&D, Operations, QA
• and other related departments as per current regulatory requirements.
• Handling queries from Regulatory Bodies from time to time.
• Regulatory gap analysis and variation application filing accordingly.
• Lifecycle Management

Review of New product development documents