Reglatory Affairs Associate Manager ( RA Associate Manager)

Keywords:

[REGULATORY AFFAIRS, REG. AFFAIRS, STRATEGY, RA, IND, NDA, ECTD, IMPD, CTA, IND AMENDMENTS, ANNUAL REPORTS, EUROPEAN, FDA, HEALTH AUTHORITY, HEALTH AUTHORITIES,CMC, MODULE 1, MODULE 2, MODULE 3, MODULE 4, PRE-IND, STRATEGY, SUBMISSIONS, COMPLIANCE, MANAGEMENT,ECTD]

Title:

Associate Manager of Regulatory Affairs (RA Associate Manager)

Role:

Reporting to the Director of Regulatory Affairs, you will take a lead role in this small regulatory team, working on the strategy behind key NDA submissions, as well as several INDs. 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 New Jersey offering a competitive salary as well as generous benefits. The right candidate should be seasoned on the various aspects of NDAs from Module 1 to Module 5.

Responsibilities:

-Take lead roles in pre-IND meetings and FDA conference calls
- Independently review and provide feedback to the promotional review committee related to promotional marketing items.
-Help guide regulatory strategy
-Lead associates and train them to review and prepare basic regulatory documents.
-Evaluates changes to regulatory documents and formulates strategies to maintain submission goals.
- Respond to queries from FDA associated with NDA submissions
-Prepare SOPs
- Provide strategic regulatory support to all functional groups in alliance projects with contract manufacturers.
-Represent RA on various product teams
- Create, organize and manage the preparation of all types of FDA submissions
-Coordinate, compile and submit regulatory applications
-Organize and maintain reporting schedules for regulatory applications

Requirements:

-Minimum of BS degree in life sciences or related field, ideally an MS or advanced degree
- At least 5-7 years of experience in the pharmaceutical industry including 3 plus years of direct regulatory affairs experience
-Experience reviewing outgoing FDA correspondences
-Experience with INDs, NDAs, BLAs, and other regulatory submissions
-Prior experience interacting with the FDA
- Knowledge of eCTD publishing software preferred
-A strong strategic background

Initial phone screenings will be conducted by the end of this week.To find out more about Real Staffing please visit www.realstaffing.com