Regulatory Affairs Specialist

ESSENTIAL DUTIES AND RESPONSIBILITIES include, but are not limited to:

  • Assists with the preparation of submissions to regulatory authorities, with minimal supervision (e.g. clinical trial applications, initial IND and maintenance submissions, annual reports, expedited safety reports).
  • Performs quality checks of regulatory submission documentation and electronic publishing output.
  • Conducts review of clinical regulatory documents.

QUALIFICATIONS:

  • Must be detail oriented
  • Strong organizational and project management skills
  • Excellent written and verbal communication skills
  • Good interpersonal skills and can deal effectively with a variety of personnel,
  • Strongly skilled with Microsoft Office programs.
  • Experience with electronic submissions is highly desired.

EDUCATION and/or EXPERIENCE:

Bachelor’s degree in a scientific field with 2-3 years’ relevant experience in the pharmaceutical or biotechnology industry.

 

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