Regulatory Associate-Biotech
Lab Support, A Division Of On Assignment - Novato, CA

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Title: Associate, Regulatory Affairs
Length: Initial term, 4 months with extension possible
Position: Regulator Affairs International

Job Responsibilities and Duties: Provide RA support for MA submissions, including completing RA intelligence activities and reports, preparing ODD applications as needed, assisting with assembly of MAs, and supporting ongoing labeling activities and other RA INTL submissions as needed.

Individual should possess at least 2 years of industry experience in the biotech/pharma industry. The RA will support marketing application submissions in Japan, Canada, Australia, and Taiwan. Add'l supported needed for preparations for Agency Meetngs, ODD applications and other related submssion activities.