Regulatory Affairs Senior CMC Associate

Keywords:

[REGULATORY AFFAIRS, REG. AFFAIRS, STRATEGY, CMC, IND, NDA, ECTD, IMPD, CHEMISTRY AND MANUFACTURING CONTROLS, ANDA, IND AMENDMENTS, ANNUAL REPORTS, EUROPEAN, FDA, HEALTH AUTHORITY, HEALTH AUTHORITIES, PRE-IND, STRATEGY, SUBMISSIONS, COMPLIANCE, MANAGEMENT]

Title:

Regulatory Affairs Associate

Role:

Reporting to the Associate Director of Regulatory Affairs, you will plan, organize, and submit RA submissions in a timely manner, and be responsible for much of the overall with regulatory requirements for generic drugs for the US markets. This is an extremely exciting opportunity in New Jersey offering a competitive salary as well as generous benefits.

Responsibilities:

-Prepares and reviews ANDA supplements, Annual Reports, Control Documents, etc. for FDA submissions
-Evaluate changes to regulatory documents and recommend appropriate filing category
-Represent Regulatory Affairs on project teams interdepartmentally
-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
-Interacts with RA colleagues world-wide
-Provide regulatory CMC expertise during due diligence
-Analyze regulatory information by determining acceptability of data, procedures, and other product-related documentation

Requirements:

-Minimum of BS degree in life sciences or related field, ideally an MS or advanced degree in chemistry or related scientific field
-Minimum 3 years in pharmaceutical regulatory affairs, with an emphasis on generics and RA strategy
-Ability to work independently and on teams
-Extensive experience in CMC and regulatory strategy
-Prior experience interacting with the FDA in the generic drug industry
-A strong analytic background and chemistry knowledge.
-Strong computer skills in Word, Excel ; RAPS RAC (U.S.)
-Demonstrates thorough knowledge of all FDA requirements pertaining to submission of regulatory documents
-Demonstrates the ability to establish and maintain good working relationships at all levels of the company

This role is looking to be filled this month for a January start, so apply now!To find out more about Real Staffing please visit www.realstaffing.com