Regulatory Affairs Assoc I #JN -062021-64851

Madison, New Jersey
Industry: Regulatory
Job Number: JN -062021-64851

Description:

  • Under close supervision, performs limited or routine duties in the preparation, review and submission of pre- and post-approval submissions to the Food and Drug Administration, using governmental guidelines and regulations.
  • Electronically prepares documentation that is complete, accurate, on time, and electronically functional. Publishes uncomplicated submissions, including eCTDs, NDAs, BLAs, supplements and advertising and promotional materials. Responsibilities also include archiving regulatory submissions in accordance with company naming standards.

 Minimum Qualifications:

  • Associates Degree in Chemistry or related field from an accredited college or university, and three (3) year pharmaceutical industry experience.

 Physical Requirements and Working Conditions:

  • Incumbents in this class are subject to extended periods of sitting, standing and walking, vision to monitor and moderate noise levels. Work is performed in an office environment.


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