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Associate, Regulatory Affairs (Temporary) - United States  

Company managed [?] Still accepting applications

Posted on : 15 April 2017

Project Description

BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

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
  • 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
  • Bachelors Degree

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We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.