Regulatory Affairs Specialist II - CMC Job Summary
Education & Qualifications
- Candidate to author CMC (Module 2.3 and 3) Common Technical Documents (CTDs) supporting an international, initial product registration at a minimum.
- The candidate must have working knowledge of biologics (preferably viral vaccines) and regulations pertaining to pre and post licensure CMC activities.
- Working knowledge must also include an understanding of ICH/ GMPs guidelines with EU regulatory experience regarded as a plus.
- The candidate must be well-organized, work with minimal management and meet aggressive timelines.
- Must utilize knowledge of word processing (software capabilities / functionality) and exhibit strong writing / analytical skills.
- BS / BA in Biology / Chemistry or related field
- Experience: 3 to 6 years with regulatory experience in drug/biologics licensure (EU regulatory experience preferred) including CMC technical writing
- CMC / Regulatory writing experience - minimum of 3 years authoring CMC documentation (CTDs)
- Scientific background (vaccines preferred)
- Microsoft Office (Word, Excel, Powerpoint, Visio, Outlook)
- Electronic documentation file systems (Veeva Vault)
- ICH / GMP guidelines
- Experience with drug/biologics licensure (EU preferred)
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.