12 Sr Associate Regulatory Affairs – CMC Jobs in Thousand Oaks, CA
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Sr Associate Regulatory Affairs – CMC
$88k-112k (estimate)
Full Time
9 Months Ago
Advanced Bio-Logic Solutions Corp is Hiring a Sr Associate Regulatory Affairs – CMC Near Thousand Oaks, CA
DescriptionNote:
"This posting is for Contingent Worker, not an FTE"
- 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?
- 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.
- 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;
- Master's degree and 2 years of Regulatory (CMC preferred), Compliance, Quality, Biopharmaceutical, Pharmaceutical and/or related scientific experience
- Bachelor's degree and 4 years of Regulatory (CMC preferred), Compliance, Quality, Biopharmaceutical, Pharmaceutical and/or related scientific experience
- Associate degree and 6 years of Regulatory (CMC preferred), Compliance, Quality, Biopharmaceutical, Pharmaceutical and/or related scientific experience
- High school diploma / GED and 8 years of Regulatory (CMC preferred), Compliance, Quality, Biopharmaceutical, Pharmaceutical, and/or related scientific experience
- 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
- Experience in Manufacturing and/or Quality Assurance
- Organized
- Flexible
- Can-do Attitude – Ideal candidate does not easily give up. The candidate will be provided direction and support but will need to be methodical and analytical when completing tasks while exhibiting a positive attitude (Very large organization and there will be many parties the candidate will need to engage with for project success).
- Being Comfortable With Being Uncomfortable – Ideal candidate will not only be able to identify problems but also identifies possible solutions. Project end goals will be known but all the in-between steps may not be known from the start so the candidate will need to navigate and structure the steps without being easily flustered.
- Attention to Detail – Ideal candidate will be thorough and deliver polished work product.
"This posting is for Contingent Worker, not an FTE"
Job Summary
JOB TYPE
Full Time
SALARY
$88k-112k (estimate)
POST DATE
12/14/2023
EXPIRATION DATE
09/15/2024
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