Regulatory Senior Affairs Manager

Keywords:

[REGULATORY AFFAIRS, REG. AFFAIRS, STRATEGY, RA, IND, NDA, ECTD, IMPD, CTA, IND AMENDMENTS, ANNUAL REPORTS, EUROPEAN, FDA, HEALTH AUTHORITY, HEALTH AUTHORITIES, PRE-IND, STRATEGY, SUBMISSIONS, COMPLIANCE, MANAGEMENT]

Title:

Senior Manager of Regulatory Affairs

Role:

Reporting to the Senior Manager of Regulatory Affairs, you will plan, organize, and submit RA submissions in a timely manner, and be responsible for much of the overall strategy. This is an extremely exciting opportunity in the New York area offering a competitive salary as well as generous benefits. The position has strong international focus, and the right candidate should have experience with regulatory projects in a diverse range of therapeutic areas.

Responsibilities:

-Prepare SOPs
-Liase with FDA
-Represent RA on various product teams
-Coordinate, compile and submit regulatory applications
-Organize and maintain reporting schedules for regulatory applications
-Lead associates and train them to review and prepare basic regulatory documents.--Evaluates changes to regulatory documents and formulates strategies to maintain submission goals.
-Maintain awareness of regulatory changes
-Take lead roles in pre-IND meetings and FDA conference calls

Requirements:

-Minimum of BS degree in life sciences or related field, ideally an MS or advanced degree
-Minimum 8 years in pharmaceutical regulatory affairs, with an emphasis on submission strategy
-Experience reviewing outgoing FDA correspondences
-Experience with INDs, NDAs, BLAs, and other regulatory submissions
-Prior experience interacting with the FDA
-A strong strategic background

First round phone interviews will be taking place prior to Thanksgiving, so don't miss this opportunity!

To find out more about Real Staffing please visit www.realstaffing.com