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Sr Associate Regulatory Affairs

1 month ago

Thousand Oaks, United States Ampcus Full time

FULLY REMOTE - Must be able to support pacific time

Ideal candidate: Change control, looking for minimum of Bachelor's degree and 4 years of Regulatory (CMC preferred), Compliance, Quality, Biopharmaceutical, Pharmaceutical and/or related scientific experience, not looking for FTE opportunities, As this role is highly visible in nature, please send candidates that are personable and pleasant over the phone (e.g., you would hire them because they are a "people person?

Overview
The Senior Associate Regulatory Affairs (CMC) provides varying levels of product support to the regulatory Chemistry, Manufacturing and Controls (CMC) department, across regions and phases of development. Support may include organizing, managing and executing on regulatory CMC projects in support of regulatory submissions. Tasks may include formatting of documents per style guide, searching for and organizing data from regulatory repository systems, drafting meeting agendas and minutes, managing document reviews, and other tasks as requested.

What we are looking for:
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;
Qualified to work in the U.S. without employer sponsorship;

Experience
o Master's degree and 2 years of Regulatory (CMC preferred), Compliance, Quality, Biopharmaceutical, Pharmaceutical and/or related scientific experience
o OR
o Bachelor's degree and 4 years of Regulatory (CMC preferred), Compliance, Quality, Biopharmaceutical, Pharmaceutical and/or related scientific experience
o OR
o Associate degree and 6 years of Regulatory (CMC preferred), Compliance, Quality, Biopharmaceutical, Pharmaceutical and/or related scientific experience
o OR
o High school diploma / GED and 8 years of Regulatory (CMC preferred), 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 Project