Manager - Regulatory Affairs

Primary Job Function: 
 

-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
 

-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

-Maintains strong working relationships with Regional Product Leads and Affiliate colleagues

-Assesses and approves change requests and updates files accordingly 
-Maintains awareness of legislation and current developments within specific a...