Sr Associate Regulatory Affairs

Sr. Associate Regulatory Affairs with experience in manufacture quality or distribution in Pharmaceutical or Biotech Industry.

Responsibilities:

• Assist RA CMC Site Regulatory to support regulatory activities (e.g. Facility registrations variations/supplements country specific documents coordination).
  
• Provide and maintain CTA/MA documentation support (e.g. Annual reports amendments) in collaboration with the Site Regulatory Lead.
  
• Appropriately archive all regulatory documents and agency communications as applicable.
  
• Ensure compliance with submissions to regulatory agencies as assigned by the Site Regulatory Affairs representative.
  
• Coordinate collection of functional documents in support of regulatory applications
  
• Monitor completion of Country Specific Document request by other Site functional areas
  
• Support the preparation of regulatory documents and packages. Provide regulatory support to Commercial Operations Process Developments New Product Introduction and/or functional groups through crossfunctional interactions within CMC.
  
• Respond to specific requests from and communicate relevant issues to Site RA CMC management.
  
• Support global registration and lifecycle management for Amgen products/site.
  
• Works cross functionally with local and global operations and regulatory personnel to coordinate preparation of regulatory filings and other documents used for registration purposes including: New marketing applications; Facility Registration documents; Country Submission Document ( CSD ) Requests.
  
  

Requirements

• Master degree or Bachelor degree and 2 years of related experience in a pharmaceutical industry environment or Associate s degree and 6 years of experience in a pharmaceutical industry environment or High school diploma / GED and 8 years of experience in a pharmaceutical industry environment.
  
• Educational background in Biotechnology Microbiology or Chemistry is preferred
  Basic navigation skills on Microsoft Office Word Excel Teams Outlook and Webex.
  
• Experience in manufacturing quality or distribution in the Pharmaceutical/Biotech industry.
  
• Strong oral and written communication skills in English and Spanish
  Proficiency working with teams at different levels
  Able to operate in a fast paced dynamic environment.