13 Associate Regulatory Affairs-CMC Jobs in Thousand Oaks, CA
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Donatech is Hiring an Associate Regulatory Affairs-CMC Near Thousand Oaks, CA
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 ForDesire 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
Commitment of a 40-hour work week
Experience o 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 QualificationsDegree 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
Job Summary
Contractor
Business Services
$81k-105k (estimate)
03/27/2024
08/30/2024
donatech.com
FAIRFIELD, IA
50 - 100
1987
ROBERT H GLAZIER
$10M - $50M
Business Services
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About Donatech
Donatech began in 1987 by writing software for aviation equipment. Today, Donatech is a talent provider to many of the largest aerospace and defense companies in the world. Other supported industries include power and distribution systems, medical and scientific, advanced manufacturing, and technology. Our employees worked in 37 states in 2016 and support all types of tasks and programs. Learn more about our employees and why Donatech has been named Supplier-of-the-Year by two Fortune 500 clients!
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