: Sr Associate Regulatory Affairs (CMC) (JP8144)
Thousand Oaks, CA
: 12 months with likely extensions
Job posting date
Remote until COVID-19 restrictions are lifted.
3 Key Consulting is hiring a Sr Associate Regulatory Affairs (CMC) for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.
What we are looking for:
- Must have CMC Pharma Biotech experience.
- 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.
- Commitment of a 40-hour work week in Thousand Oaks, California.
- Master's degree and 2 years of Regulatory (CMC preferred), Compliance, Quality, Biopharmaceutical, Pharmaceutical and/or related scientific experience
- OR Bachelor’s degree and 4 years of Regulatory (CMC preferred), Compliance, Quality, Biopharmaceutical, Pharmaceutical and/or related scientific experience
- OR Associate degree and 6 years of Regulatory (CMC preferred), Compliance, Quality, Biopharmaceutical, Pharmaceutical and/or related scientific experience
- OR High school diploma / GED and 8 years of Regulatory (CMC preferred), Compliance, Quality, Biopharmaceutical, Pharmaceutical, and/or related scientific experience.
Top Must have Skill Sets:
- 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
- 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 (Amgen is a 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.
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 Amgen processes that support the making of human therapeutics and the patients that use them.
• Leaving assignments before projects are complete
• Unexplainable time gaps in resumes
• References that are not from recent employers
• References that are not direct supervisors
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.
We invite qualified candidates to send your resume to firstname.lastname@example.org. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com
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