Regulatory Affairs Associate II

San Rafael, CA 94901

Posted: 09/11/2017 Employment Type: Contract Industry: Regulatory Affairs & Compliance Job Number: 3283

Our client  focuses on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.

 

Duties:
  • Assemble FDA and ex-US  regulatory filings and briefing books, leveraging subject matter experts. 
  • Work with supervisors and vendors to plan filing schedules.
  • Work with publishing group to plan and finalize submissions.
  • Research regulatory requirements.

 

Skills:

  • Minimum of 2 years experience in Regulatory Affairs in the biotechnology industry Prior experience managing ex-US regulatory filings and associated vendors/CROs is required.
  • Prior experience reviewing Informed Consent Forms, Reviewing drug shipment packages, and eTMF filing highly desireable.
  • Prior experience compiling filings for FDA submissions is highly desireable.
  • Proficient with computer and standard software programs.
  • Strong interpersonal and communication (written and verbal) skills.
  • Effective task planning and coordination abilities.
  • Capable of working with an interdisciplinary team.

 

Education:

  • B.S. in life sciences or equivalent.
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