Regulatory Writer - CMC, CTDs in Swiftwater, PA at Apex Life Sciences

Date Posted: 9/12/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    9/12/2018
  • Job ID:
    885489

Job Description


Responsibilities:

  • Author CMC (Module 2.3 and 3) and Common Technical Documents (CTDs) supporting an international,initial product registration
  • Utilize working knowledge of biologics, viral vaccines, and regulations pertaining to pre and post licensure CMC activities.
  • Perform work with minimal management and meet aggressive timelines.
  • Utilize knowledge of word processing and exhibit strong writing and analytical skills.
Qualifications:
  • BS or BA in Biology, Chemistry, or related field
  • Strong Scientific background with knowledge in vaccines preferred 
  • 3+ years with regulatory experience in drug and biologics licensure required
  • 2+ years experience writing and authoring CMC documentation (CTDs)
  • Proficient with Microsoft Office including Word, Excel, Powerpoint, Visio, Outlook
  • Knowledge of electronic documentation file systems required; Veeva Vault knowledge desired
  • Understanding of ICH / GMP guidelines required
  • EU regulatory experience highly preferred

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




885489