Regulatory Affairs Associate - II

Job Description

Foster City, CA

Contract Duration: 12-18 months

Rate: Negotiable

Responsibilities:

Excellent employment opportunity for a Regulatory Affairs Associate II in the Foster City, CA area. (Onsite Role)

Contractor must meet the company site requirements for the COVID Vaccination PRIOR to starting role

Responsible for the preparation of Drug Listings/Lot Distribution Reports (Biologics)

Responsible for compiling documentation and sending Certificate of Pharmaceutical Product (CPP) requests to FDA

Manage Notarizations (CA licensed notary public a plus), Legalization/apostille of regulatory documents

Assist in documentation and signature preparation for:

License renewals

Establishment registration

Performs document filing and retrieval functions as directed, or in conjunction with departmental SOPs and work instructions and direction of a senior Regulatory Affairs professional.

Performs workflows and procedures regarding document tracking, indexing and retrieving, and disseminating information to the Regulatory Affairs CMC department.

Seeks assistance from appropriate internal and external resources.

Participates in preparing regulatory submissions under direction of a senior Regulatory Affairs Professional which require some interactions with other members in the Regulatory department 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 knowledge, with guidance from immediate supervisor.

Assist with miscellaneous US RA CMC team-related administrative documents/activities such as processing of invoices.

Participates in group meetings and provides tactical approaches to addressing issues of moderate complexity and seeks assistance from appropriate internal and external resources.

Experience:

A Bachelor's Degree with a minimum of 2+ years of relevant training or industry experience preferably in a GMP environment, OR 1+ years relevant training or industry experience preferably in GMP environment with advanced degree.

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

Strong computer and organizational skills required.

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

Preferred:

Degree in a relevant Scientific field

Relevant Regulatory CMC submission experience