Dossier Manager - Global Regulatory Operations

As a Dossier Manager you provide an Global Regulatory Operation (GRO) interface to Regulatory partners, and your responsibility is to support and navigate submission projects to regional partners and Health Authorities and update Lifecycle Management system for defined products.




YOUR DIRECT RESPONSIBILITIES:
• COLLABORATE AND SERVE AS A NAVIGATOR FOR THE REGULATORY PROJECT TEAMS, REGARDS TO THE OPERATIONAL ASPECTS OF PUBLISHING, SUBMISSION AND TRACKING OF REGULATORY SUBMISSIONS
• DEVELOP AND MAINTAIN STRONG PARTNERSHIPS WITH LOCAL AND GLOBAL CUSTOMERS AND PARTNERS
• ACTING AS THE FIRST POINT OF CONTACT TO THE EXPERTISE WITHIN GRO REGARDS TO DOCUMENT PUBLISHING, SUBMISSION PUBLISHING AND SUBMISSION TRACKING
• UPDATE LIFECYCLE MANAGEMENT SYSTEM FOR DEFINED PRODUCTS
• SUPPORT LIFECYCLE MANAGEMENT REPORTS TO SUPPORT LIFECYCLE COMPLIANCE

ESSENTIAL REQUIREMENTS
• UNIVERSITY DEGREE IN SCIENCE OR RELATED EXPERIENCE
• PROVEN LEADERSHIP SKILLS OF GLOBAL CROSS FUNCTIONAL PROJECT TEAMS
• RELEVANT EXPERIENCE OF WORKING IN ONE OR MORE AREAS IN REGULATORY AFFAIRS IN THE PHARMACEUTICAL OR RELATED INDUSTRY
• FLUENT IN ENGLISH, WRITTEN AND SPOKEN

DESIRABLE REQUIREMENTS
• Experience of working with Regulatory document or submission publishing, understanding the different procedures, formats and market requirements
• Planning for and managing submission publishing activities