Search Jobs

Scientific. Clinical. Software Engineering

Snr Regulatory Specialist

Edison-New Brunswick Metro Area, NJ

Job Type: Scientific Job Number: JN -042020-26673 Region: Edison-New Brunswick Metro Area

Job Description

BS/BA in a scientific field.

Preparing, compiling, reviewing and processing the regulatory submissions documents including both pre-approval and submissions such as IND, NDA/BLA, MAA, amendments/supplements, annual reports, etc.

Coordinating and consulting with other concerned functions on the content, and assembly of regulatory documentation and ensuring consistency, completeness and adherence to standards for all the regulatory submissions.

Assist with regulatory communications with the FDA for assigned products and activities, including preparing and formatting of FDA meeting requests, briefing book, meeting rehearsals/slides, meeting minutes of the FDA meetings and the generation of responses to the FDA queries.

Good oral and written communication skills Experience with Veeva electronic document management system Project management skills,

Apply Online

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.