Minimum Qualifications include: 

• Bachelors degree in a scientific discipline such as Chemistry, Biology, Microbiology, or equivalent.
• Direct experience with small molecule or biological pharmaceutical products.
• Seven years of regulatory affairs experience within the biotech or pharmaceutical industry with three years of those years demonstrating management and authoring of regulatory submissions in the U.S.
• Demonstrated experience with MS Office Suite with a strong proficiency in MS Word.
• Knowledge of biotech R&D and writing/preparing regulatory submissions in the Common Technical Document format.

The successful candidate will possess the following knowledge and abilities: 

• The successful candidate will have experience in the preparation, assessment, and submission of regulatory filings in the U.S. and preferably experience in European or Canadian submissions. eCTD submission/maintenance experience a plus.
• The ability to function in a fast-paced, high-growth, entrepreneurial environment.
• Strong, professional interpersonal skills including ability to communicate effectively with people both individually and in groups.
• Good working knowledge of regulatory affairs, drug development, and clinical requirements. CMC and/or clinical requirements knowledge a plus.
• Demonstrated ability to work independently and take initiative in scheduling and meeting deadlines, and providing timely follow up reports to supervisors.
• Good communication skills and ability to work effectively in a remote environment.
• Experience with antiviral or anti-infective drugs a plus.
• Is a team player who can work flexibly and enthusiastically within a small business environment.