Associate Regulatory Affairs

What we are looking for:

Desire to learn Regulatory Affairs CMC and global submission strategy

Strong organizational skills with attention to detail

Proficient time management skills and ability prioritize workload

Ability to work both independently and as a member of a team

Proficient skills in Microsoft Office suite, especially Word, Excel, PowerPoint and Project

Experience:

Bachelor's or Master degree with 1 to 2 years of either Regulatory, Compliance, Quality, Biopharmaceutical, Pharmaceutical or related scientific experience

OR

Associate degree and 6 years of either Regulatory, Compliance, Quality, Biopharmaceutical, Pharmaceutical or related scientific experience

OR

High school diploma / GED and 8 years of either Regulatory, Compliance, Quality, Biopharmaceutical, Pharmaceutical, and/or related scientific experience

Preferred Qualifications

Degree in life sciences, biochemistry, or chemistry

Experience in biopharmaceutical or pharmaceutical industry

Familiarity with eCTD structure

Motivated with initiative to learn quickly

Experience in CMC, including preparation of submissions to Agencies

Proficient skills in Microsoft Office suite, especially Word, Excel, PowerPoint and