RA CMC Associate Level II
333 Lakeside Drive San Mateo, CA 94404 US
Specific Job Responsibilities:
Pay rate range: $30-33/hr
Participates in preparing moderately complex CMC regulatory submissions under direction of a senior Regulatory Affairs professional which require some interactions with other members in the Regulatory CMC department and technical teams as well as senior stakeholders for investigational and commercial products in line with US and ICH requirements, regional requirements and scientific and company policies and procedures.
Works to develop and acquire required regulatory skills and basic CMC knowledge, with guidance from immediate supervisor.
Assist with miscellaneous US RA CMC team-related administrative documentation/tracking and product maintenance activities. Performs workflows and procedures regarding document tracking, indexing, and retrieving, and disseminating information to the Regulatory Affairs CMC department.
Participates in group meetings and provides tactical approaches to addressing issues of moderate complexity and seeks assistance from appropriate internal and external resources.
Work cross-functionally within a matrixed organization.
Must work well under deadlines and have excellent attention to detail in alignment with project goals and regulatory submission timelines.
Strong computer and organizational skills required.
Excellent verbal and written communication skills and interpersonal skills are required.
Education & Experience:
A Bachelors Degree with a minimum of 2+ years of relevant training or industry experience preferably in a GMP environment, OR 1+ years relevant training and industry experience preferably in GMP environment with advanced degree.
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