Amgen Regulatory Affairs CMC Manager in Rhode Island, Rhode Island
The Regulatory Affairs CMC Site Team is responsible for input to the development and implementation of CMC regulatory strategies and activities for products manufactured at or planned for the specific site. The CMC site team interfaces with the site (R&D and operations authors) coordinate preparation of regulatory filings, identification of issues and factors that may implicate a regulatory strategy or activity. The CMC site team are members of CMC product teams. The CMC Site team is also responsible for coordination of site-specific change control regulatory assessments with input from the CMC Product teams and the CMC Region representative. The CMC site team is the key RA CMC representative on product deviation investigation teams.
Responsible for the strategy and execution of the site-specific aspects of the preparation of CMC investigational product amendments and post-market supplements, organization and preparation CMC sections of IND annual reports and annual reports of minor changes for specific products; acts as key RA CMC representative on product deviation investigation teams, participates in site change control teams.
Doctorate degree OR
Master’s degree and 3 years of Regulatory & Compliance experience OR
Bachelor’s degree and 5 years of Regulatory & Compliance experience OR
Associate’s degree and 10 years of Regulatory & Compliance experience OR
High school diploma / GED and 12 years of Regulatory & Compliance experience
6+ years’ experience in manufacturing, testing (QC/QA or clinical), or distribution in Pharmaceutical/Biotech industry
Regulatory CMC experience
Ability to develop solutions to technical and organizational issues in order to improve performance and productivity
Able to work independently and proactively
Strong computer skills, including word processing, database document repository and project management software
Able to influence vertically and across functional boundaries
Strong team player with a commitment to customer service