Manager Regulatory Affairs, CMC Biosimilar

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

4. Compliance across Life-Cycle

-Assesses and approves change requests and updates files accordingly

-Maintains awareness of legislation and curren...