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CMC Regulatory Affairs Specialist at Apex Systems, Inc

Posted in Information Technology 30+ days ago.

This job brought to you by Professional Diversity Network, Inc

Type: Full Time
Location: Summit, New Jersey

Job Description:

Author technical documents in internal Documentum system.
Perform technical writing and authoring CMC documents following ICH and GMP guidelines
Expected to stay well-organized, work with minimal management, and meet aggressive timelines.
Utilizes knowledge of word processing software, strong writing and analytical skills to document software capabilities and functionality.
BS degree required
3 + years authoring CMC regulatory documents
Experience working in the pharmaceutical and/or clinical research industries
Experience with drug/biologics licensure desired
Working knowledge of bacterial biologics and vaccines and regulations pertaining to pre and post licensure activities related to CMC
Microsoft Office (word, excel, powerpoint)
Documentum and Trackwise Applications
Experience with ICH and GMP guidelines
Prior regulatory experience a must
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 or 844-463-6178.
VEVRAA Federal ContractorWe request Priority Protected Veteran & Disabled Referrals for all of our locations within the state.We are an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic. The EEO is the Law poster is available here.