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Associate Regulatory Affairs-CMC
Thousand Oaks, CA
Job Description
What we are looking for:
- Desire 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
Experience:
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 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
Ampcus is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identify, national origin, age, protected veterans or individuals with disabilities.
Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
High School or Equivalent
Required Experience
1 to 2 years
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