eNewsletter Signup
Miles
Km80.5

Regulatory Operations Specialist, Sr Specialist, or /Manager

Cost Management Incentives, Inc.

E-Mail to a Friend Add to Job Folder View All Jobs Back to Search Results Share
Location: Jersey City, NJ Posted Date: 4/8/2013 Position Type: Full time Job Code: RegAffNJ Required Education: High school or equivalent Areas of Expertise Desired: Clinical Research
Medical Writing
Regulatory Affairs

Description

This individual will be the representative for assigned project(s) (i.e., INDs, IND amendments, annual reports, FDA meeting packages, NDAs, NDA amendments, etc.) He/she will  functions  as a Project Manager, working with other departmental and company representatives to ensure that all required reports and documentation are prepared and submitted on a timely basis.  

The Specialist/Sr. Specialist/Manager Regulatory Operations is responsible for the scheduling, timelines, follow-up, and preparation of all IND/NDA Annual Reports, Amendments, Briefing Documents and other periodic submissions in support of regulatory filings to regulatory agencies This person will ensure that all regulatory requirements are accurately completed, in accordance with established timelines, for assigned project(s), including preparing regulatory documents (ie INDs, Amendments, Supplements, Safety Reports, Annual Reports, Agency meetings/briefing documents, etc.).  this person will l also draft  general correspondence for submission to regulatory agencies for all assigned clinical development and/or marketed products. Person will provide guidance and support for organization, formatting, and structure of assigned regulatory submissions (IND, NDA) for assigned products and/or therapeutic area(s), support the scheduling and timelines of major regulatory submissions and act  as contact for collection of required documents from participating departments, and distribution of those documents for review and approval by Regulatory Affairs management

Requirements

Minimum BA/BS or equivalent work experience in life science or closely related field;  minimum of three (3)+ years direct experience with regulatory submissions in the pharmaceutical industry, including experience preparing and drafting variety of regulatory documents
E-Mail to a Friend Add to Job Folder



By applying to/saving a job using , you are agreeing to comply with and be subject to the Terms of Use for use of our website. To use our website, you must agree with the Terms of Use and both meet and comply with their provisions.

ADVERTISEMENTS