Senior Manager Of Regulatory Affairs

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:

Manager of Regulatory Affairs

Role:

Reporting to the AD 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 Virginia 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:

- Respond to queries from FDA associated with NDA submissions
-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.
-Take lead Role in NDA submission strategy
-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
-Lead associates and train them to review and prepare basic regulatory documents.--Evaluates changes to regulatory documents and formulates strategies to maintain submission goals.

Requirements:

-Minimum of BS degree in related field, ideally an MS or advanced degree
- At least 4-6 years of experience in the pharmaceutical industry including 4 plus years regulatory affairs
-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 backgroundTo find out more about Real Staffing please visit www.realstaffing.com