Regulatory Affairs Associate - MedFocus (California)

Regulatory Affairs Associate - MedFocus (California)
Apply to jobs now hiring in California today!

Job Description:

A Regulatory Affairs Associate is needed for a 6-month contract position at major pharma company in Northern California.

Duties: The Associate, Regulatory Affairs is responsible for the coordination, preparation and submission of a variety of regulatory submissions including INDs, CTAs, BLAs and NDAs to regulatory authorities.

Responsibilities:

* Attend project team meetings across functional areas

* Prepare, submit, and maintain domestic and international regulatory filings, both pre and post approval

* Assist with and coordinate meetings with regulatory authorities

* Assist with development strategy

* Support the filing, review, and approval of global license applications

* Support for multiple projects if necessary

* Other duties as assigned

Education and Experience:

* Bachelor’s Degree

* 2-3 years industry experience in the pharmaceutical or 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

Please send resume to jobs@inventivhealth.com

*Min Salary:* $0.00

*Max Salary:* $0.00

*State:* CA

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