Manager - Regulatory Affairs

JOB DESCRIPTION: Primary Job Function: With Manager Support:- 1. Product registrations / Submissions -Actively leads product registrations by preparing/ requesting documentation needed for complex filings -Employs project management skills to monitor activities and meet deadlines -Prepares registration packages for routine filings -Identifies and collects data needed -Seeks expert advice and technical support for complex filings -Prepares responses to deficiency letters 2. Relationships & Cross Functional team work -Represents Regulatory CMC at relevant project meetings and communicates agreed RA position -Monitors and communicates actual versus planned regulatory activities and timelines -Identifies and communicates risks and issues impacting project progression 3. Affiliate Coordination -Maintains strong working relationships with Regional Product Leads and Affiliate colleagues 4. Compliance across Life-Cycle -Assesses and approves change requests and updates files accordingly -Maintains awareness of legislation and current developments within specific area of business -Works to assure products remain in compliance 5. Strategy -Develops Regulatory CMC strategies for assigned products and projects -Identifies, communicates, and mitigates Regulatory CMC risks 6. Process Improvement -Identifies opportunities and suggests improvements -Supports the development of position papers & work aids etc 7. Health Agency Interaction -Attends Health Agency meetings as appropriate 8. Licensing Reviews -Provides CMC Regulatory support for due diligence activities 9. Technical competency -Has general knowledge of technical/scientific principles and develops specific knowledge of allocated products -Has general knowledge of global and regional regulatory requirements -Has specialist regulatory knowledge of assigned country or product-class requirements CORE COMPETENCIES Adaptability -Effectively prioritizes mid-term (weeks) to longer-term (months) work tasks -Regularly reviews commitments and re-prioritises activities or negotiates timelines as necessary -Reacts quickly to solve problems and issues when they arise Initiative -Starts to learn new aspects of the business and understand the roles of other functions -Proactively anticipates, mitigates and avoids problems and issues -Proactively seeks feedback from manager and team members and adapts behaviour to improve performance Innovation -Has an intrapreneurial mindset to identify new or unique ways to address work problems or opportunities Integrity -Delivers high quality results. -Meets agreed deadlines. -Exhibits honesty and presents complete impartial information. -Displays consistency between words and actions. -Acknowledges and responds constructively to failures and mistakes. -Expresses dissatisfaction constructively, without over-reacting. Teamwork -Actively interacts with colleagues to drive completion of team and shared goals LEADERSHIP COMPETENCIES Set Vision and Strategy