Regulatory Affairs Specialist

San Francisco, CA 94158

Posted: 03/09/2018 Employment Type: Contract Industry: R&D Job Number: 3978

Our client is a clinical-stage biopharmaceutical company developing a pipeline of drug candidates which are designed to improve the benefits of drugs for patients. 

 

Duties:
  • Under the direction of AD Regulatory Operations, assists in gathering and assembling information necessary for submissions in accordance with regulations and relevant guidelines.  
  • Maintains regulatory submissions and correspondence archives for Company sponsored projects, and all company related sections for partner sponsored projects.  
  • Provides general administrative support to Regulatory Operations staff including formatting and processing submissions documents, assembling and preparing briefing books for FDA submissions.
  • Follows general instructions to complete projects.  Organizes workday to complete mid-term assignments.

 

Skills:

  • Must be able to demonstrate excellent organizational, planning and follow-up skills.
  • Excellent word processing, and graphic documentation skills are required.
  • Must be able to demonstrate a good attention to details and be goal-oriented, and quality conscientious.
  • Strong computer skills in Word, Excel and Adobe Acrobat Pro, with a working knowledge of electronic publishing/file management systems are an asset.  
  • Strong oral and written communication skills are required.
  • Must be able to adapt to changing priorities and manage multiple tasks.

 

Education:

  • A minimum of a Bachelor’s degree in a scientific discipline is preferred.  
  • Equivalent experience may be accepted.
  • A minimum of 2 years related industry experience is required. 
  • A minimum of 2 years hands-on Regulatory Affairs experience preferred.
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