Regulatory Affairs Associate Director

Title:

Regulatory Affairs Associate Director

Role:

Reporting to the VP of Regulatory Affairs, you will provide strategic regulatory guidance to cross-functional project teams. You will be responsible for product development and organizing submissions in a timely manner. You will interact with regulatory agencies to negotiate agreements, coordinate planning, and conduct of regulatory agency meetings. This is an extremely exciting opportunity in New Jersey offering a competitive salary as well as generous benefits.

Responsibilities:

-Reporting to the Vice President of Regulatory Affairs
-Lead development and implementation of regulatory strategy for assigned programs
-Supervise changes to regulatory documents and recommend appropriate filing category to ensure compliance with FDA regulations and guidelines.
- Perform U.S. and international regulatory research tasks
-Act as liaison with the FDA and other regulatory agencies including European Health Authorities
- Mentor and coach regulatory staff and other team members
-Reviews regulatory and related publications to assure compliance and anticipate future regulatory action
-Coordinate compilation and reviews CMC data package for appropriate and complete documentation

Requirements:

- BS degree in life sciences or related field, ideally an MS or advanced degree in chemistry or related scientific field
- 8+ years in pharmaceutical regulatory affairs, with an emphasis on generics and RA strategy
-Ability to work independently and on teams
-Extensive experience in regulatory strategy
-Prior experience brining drugs to market and interacting with the FDA
-Demonstrate thorough knowledge of all FDA requirements pertaining to submission of regulatory documents

This role is looking to be filled this month for a JanuaryTo find out more about Real Staffing please visit www.realstaffing.com