Regulatory Affairs Specialist 5

Job Description

Job Description:
Candidate to author technical documents in Client's internal documentum system. Must have working knowledge of bacterial biologics and regulations pertaining to early and late phase pre-licensure activities. Must have working knowledge of GMPs and application to preparing clinical materials. Must be 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.

Job Responsibilities:
**This position is working in the CMC area. Relevant experience is required
Experience: 3 to 6 years
Experience with drug/biologics licensure
Prior regulatory experience
Technical writing experience (CMC experience )
Scientific background,

Required Skills:
CMC/ Regulatory writing experience
Scientific background, vaccines preferred
Microsoft Office (word, excel, powerpoint)
Documentum Applications
Trackwise Applications
ICH Guidelines
GMP experience
Experience with drug/biologics licensure
Prior regulatory experience

Education:
BS in Biology/Chemistry or related field

Qualifications

BS

Additional Information

For more information, Please contact

Akriti Gupta

Office: 973.967.3409 | Fax: 973.998.2599