Regulatory Affairs Associate - II (Hybrid/CMC/GMP/Pharma/Healthcare)JK

Cube Hub Inc. • Independent • US, CA, Foster City • 4w ago

Job Title: Senior Associate - Regulatory Affairs CMC

Location: **Onsite-Hybrid ** (Foster City, California)

Duration: 12 Months contract-Possible to extend

Shift Details: 1st shift

Pay Range : $68/h to $70/h

Job Description

Specific Job Responsibilities:

Responsible for the preparation of moderately complex regulatory submissions which require interaction with departments outside of Regulatory Affairs CMC for investigational products and marketed products for US in line with ICH requirements, regional requirements and scientific and company policies and procedures.

Responsible for routine clinical and commercial labeling approvals and changes, protocol reviews, drug listing review and ensure product packaging and associated information is updated and maintained in accordance with the product license.

Develop and maintain knowledge of regulatory requirements independently and with line manager.

Assess change controls for regional regulatory impact and record assessment using a variety of internal systems.

Contribute to local process improvements, which have an impact on the working of the RA CMC function or other departments.

Work cross-functionally within a matrixed organization.

Primarily plans, schedules and arranges own activities in alignment with project goals and deadlines.

Must be capable of leading a small team in preparation of regional submissions.

Must work well under deadlines and have excellent attention to detail. Strong computer and organizational

skills required. Work is performed under limited direction of a senior Regulatory Affairs professional.

Excellent verbal and written communication skills and interpersonal skills are required.

Education & Experience

A Bachelor's Degree with a minimum of 5+ years of relevant training or industry experience in Biologics, preferably in a GMP environment.

OR a Master's Degree with a minimum of 2+ years of relevant training or industry experience preferably in a GMP environment.

Preferred Degree In a Relevant Scientific Field.

Relevant Regulatory CMC submission experience. Must be knowledgeable of regulatory requirements, including ICH requirements and US regional requirements.

Regulatory Affairs Certification (RAC) is a plus but not required.