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Senior Associate, Regulatory Affairs, Clinical and Nonclinical
Ref No.: 18-13930
Location: San Rafael, California
Hours: 8:00am to 5:00pm

This position will play a key role in preparing US and international regulatory filings for both early and late-stage products designed to treat rare, unmet medical conditions. The position will focus on the clinical and nonclinical aspects of regulatory affairs and will work closely with cross-functional team members.

Prepare, submit, and maintain domestic and international regulatory filings, both pre and post approval
Attend project team meetings across functional areas
Coordinate meetings with regulatory authorities
Assist with development strategy
Support the filing, review, and approval of global license applications
Supporting the preparation and filing of INDs and CTAs
Support for multiple projects if necessary
Other duties as assigned

Required Skills:
At least 2-4 years of experience in Regulatory Affairs in the biotechnology industry
Proven ability to manage critical projects with a minimum of supervision
Prior experience compiling filings for FDA submissions is required with the ability to successfully manage projects to deadlines
Prior experience in a product development role
Proficient with computer and standard software programs
Strong interpersonal and communication (written and verbal) skills
Effective task planning and coordination abilities
Demonstrated good judgment
Capable of working with an interdisciplinary team
Strong understanding of US FDA regulations applicable to therapeutic products.
While not rqeuired, the ideal candidate will have:
Prior experience preparing ex-US CTAs.
Prior experience with orphan products.

BS degree (advanced degree desirable) in life sciences or equivalent.