Regulatory Affairs Associate

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

Bachelors degree in a scientific field with 2 to 3 years relevant experience in the pharmaceutical or biotechnology industry. Must be detail oriented, have strong organizational and project management skills, have excellent written and verbal communication skills, have a good interpersonal skills and be able to deal effectively with a variety of personnel, be strongly skilled in Microsoft office programs. Experience with electronic submissions is highly desired.



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