Sr Associate Regulatory Affairs
One Amgen Center Drive Thousand Oaks, CA 91320
Must be Bi-lingual English/Spanish- both written and verbal. BS or MS in Health Sciences (Biotechnology, Chemistry, Biology, Biochemistry, Pharmacy or similar). Manager would also look at recent grad or someone completing MS in regularly with no industry experience if bi-lingual and right type or person. Cross functional role-will be collaborating, QC labeling documentation, complaining and submitting submissions and compiling data and archiving in a highly regulated document.
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.
Top Skill Sets:
1. Good communication skills (both oral and written) within a technical and clinical environment (Fluent in both English and Spanish: high level command on written, reading and speaking skills)
2. Action orientated with ability to manage multiple activities.
3. Document management and archiving practices with high attention to detail