Manager Regulatory Affairs CMC

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:

Manager of Regulatory Affairs CMC

Role:

Reporting to the Associate Director of CMC Regulatory, you will plan, organize, and submit RA submissions in a timely manner, and be responsible for much of the overall CMC strategy. This is an extremely exciting opportunity inNew Jerseyoffering a competitive salary as well as generous benefits.

Responsibilities:

-Coordinates compilation and reviews CMC data package for appropriate and complete documentation
-Independently provide project team representation while working closely with Manufacturing, Quality, Technical Support/service groups and Site Senior management
-Interacts with RA colleagues world-wide
-Provide regulatory CMC expertise during due diligence
-Maintains Change Control Request process of Change Requests received in CMC
-Coordinate regulatory document packages to support post-market changes at the Site
-Provide project team representation, consults on regulatory project needs and is responsible for developing required regulatory documentation/submissions
-Provide direction in managing information from other departments
-Recommends/approves changes for manufacturing and compliance, ensuring conformance with existing regulatory approvals
-Analyze regulatory information by determining acceptability of data, procedures, and other product-related documentation
-Minimum of a MS Degree in a scientific discipline with 10+ years of regulatory affairs (biologics or drugs)
-Represent RA on various product teams
-Organize and maintain reporting schedules for regulatory applications
-Provide regulatory CMC expertise during negotiations and interactions with regulatory agencies

Requirements:

-Minimum of BS degree in life sciences or related field, ideally an MS or advanced degree in chemistry or related scientific field
-Minimum 8 years in pharmaceutical regulatory affairs, with an emphasis on CMC and RA strategy
-Extensive experience in CMC and regulatory strategy
-Prior experience interacting with the FDA
-A strong analytic background and chemistry knowledge.

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