Sr Associate Regulatory Affairs
One Amgen Center Drive Thousand Oaks, CA 91320 | Contract
Ideal candidate- Must be Bi-lingual English/Spanish- both written and verbal. BS or MS in Health Sciences (Biotechnology, Chemistry, Biology, Biochemistry, Pharmacy or similar). Cross functional role-will be collaborating, QC labeling documentation, complaining and submitting submissions and compiling data and archiving in a highly regulated documents.
The Regulatory Affairs Coordinator will be responsible for:
• Local coordination and execution of regulatory submissions in compliance with corporate standards and local regulatory requirements.
• Management and execution of the preparation, delivery and electronic archiving of documentation for inclusion in local regulatory submissions.
• Coordination and execution of Regulatory Affairs processes and deliverables.