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Sr Associate Regulatory Affairs – CMC

South San Francisco, CA
Top 3 Must Have Skill Sets:
    
1) 1-2 years work experience in Regulatory Affairs or Quality Assurance. CMC experience preferred. 2) Work experience related to biotech or small molecule product. 3) Knowledge or work experience related to CTAs, INDs, Marketing Applications and ICH CTD structure and format

Description:

Onsite after covid policy is lifted
Thousand Oaks Location
Must be able to report in Thousand Oaks 5 days per week.

Overview
The Senior Associate Regulatory Affairs (CMC) provides varying levels of product support to the regulatory Chemistry, Manufacturing and Controls (CMC) department, across countries 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, 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;
• Commitment of a 40-hour work week in Thousand Oaks, California
• 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

Daily Responsibilities
Daily responsibilities will be focused on providing submission execution support to products across modalities, regions and phases of development
Employee Value Proposition
You will work directly with project teams in Thousand Oaks in support of submission execution. The projects you will be involved with will have a positive impact on key processes that support the making of human therapeutics and the patients that use them.
Red Flags
• Leaving assignments before projects are complete
• Unexplainable time gaps in resumes
• References that are not from recent employers
• References that are not direct supervisors
Interview Process
Phone screening of possible candidates. In-person interview for those who pass the phone screening. We can start interviewing immediately and will be available as needed.
Additional Onboarding Requirements
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”).

"This posting is for Contingent Worker, not an FTE"
 

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