Amgen Senior Associate Regulatory Affairs CMC - RI Site in West Greenwich, Rhode Island
To facilitate product development and global registration by developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle.
The RA 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 site functions to coordinate preparation of regulatory filings, identification of issues and factors that may implicate a regulatory strategy or activity. 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 to provide regulatory input to product deviation investigation teams.
The RA CMC Senior Associate will interface with global and regional CMC regulatory leads, site teams and supply chain for specific strategies or activities that impact a product or multiple products. The RA CMC Sr Associate will be responsible for varying levels of product support, including leading projects, based upon their experience level.
Responsible for regulatory assessments of change control requests
Contributes to site inspections: provides and may present Amgen corporate/ portfolio information and regulatory role within change control.
Contributes to the organization and preparation of CMC post-market supplements, facility registrations, and annual reports of minor changes for specific products to meet the strategy defined by the global CMC team
Responsible for documenting CMC submissions and related communications in IMR; archiving documents in document management systems
May be responsible for training staff on select CMC procedures and systems.
Contributes to CMC product teams: interacts with authors/reviewers with respect to delivery of documents for required for regulatory submissions; provides reports status of activities and projects to teams and department.
May participate in cross-functional special project teams.
Contributes to the design and content development of department training programs.
CMC- specific regulatory knowledge & experience
Understanding and application of principles, concepts, theories and standards of scientific/technical field
Bachelor’s degree and 2 years of directly related experience
Associates degree and 6 years of directly related experience
High school diploma / GED and 8 years of directly related experience
Degree in Life Science discipline
5+ years’ experience in manufacture, testing (QC/QA or clinical), or distribution Pharmaceutical/Biotechnology industry; 3-5 years regulatory CMC
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.