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Ampcus Inc. is a certified global provider of a broad range of Technology and Business consulting services. We are in search of a highly motivated candidate tjoin our talented Team.
Job Title: Senior Associate Regulatory Affairs
Location(s): Thousand Oaks, CA (Remote)
Overview
The Senior Associate Regulatory Affairs (CMC) provides varying levels of product support tthe 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 tdetail;
- Proficient time management skills and ability prioritize workload;
- Ability twork both independently and as a member of a team;
- Proficient skills in Microsoft Office suite, especially Word, Excel, PowerPoint and Project;
- Qualified twork in the U.S. without employer sponsorship;
- Commitment of a 40-hour work week in Thousand Oaks, California
Experience
- 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.
Preferred Qualifications
- Degree in life sciences, biochemistry, or chemistry.
- Experience in biopharmaceutical or pharmaceutical industry.
- Familiarity with eCTD structure.
- Motivated with initiative tlearn quickly.
- Experience in CMC, including preparation of submissions Agencies.
- Proficient skills in Microsoft Office suite, especially Word, Excel, PowerPoint and Project.
Top 3 Must-Have Skill Sets
- Can-dAttitude - Ideal candidate does not easily give up. The candidate will be provided direction and support but will need tbe methodical and analytical when completing tasks while exhibiting a positive attitude (Client is a very large organization and there will be many parties the candidate will need tengage with for project success).
- Being Comfortable With Being Uncomfortable - Ideal candidate will not only be able tidentify problems but alsidentifies possible solutions. Project end goals will be known but all the in-between steps may not be known from the start sthe candidate will need tnavigate and structure the steps without being easily flustered. Attention tDetail - Ideal candidate will be thorough and deliver polished work product.
- Daily Responsibilities Daily responsibilities will be focused on providing submission execution support tproducts 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.
Ampcus is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veterans or individuals with disabilities.
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Ampcus, Inc
Apr 07, 2025