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.
- 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.