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Regulatory affairs Associate

Company Name:
MaxisIT
Assist in preparing and maintaining regulatory submissions (EU, NDA, IND). Prepare responses to questions from regulatory agencies and guidance. Review technical documents for submissions and provide QC checks for accuracy. Participate in cross functional teams for development projects. Maintain regulatory procedures and track and report status.
Some knowledge of current FDA regulatory requirements and trends
Knowledge of software, EDMS system
Ability to work with personnel at all levels and functions
Attention to details
2-5 years of RA experience preferred
Good prioritizing, organizational, interpersonal, communication and analytical skills.
Good computer skills
Bachelor's Degree in Scientific discipline preferred.
Location: South San Francisco, CA.
Contact: Venkata Giri
The best telephone number to reach me is 732-276-9940 Ext: 325. I appreciate if you forward your updated word formatted resume at /\ for review before we speak.

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