Below is the Job Description for your reference:
Job Title: Regulatory Affairs Specialist III
Location: Bridgewater NJ
Contract: Long Term Contract
The Regulatory ERDL Coordinator is responsible for:
Accurate assignments of manufacturer NDCs
Prepares annual Blanket No changes Certification for Product and plant NDCs
Maintain database of current and historical NDC assignments, with periodic review of data to ensure accuracy and completeness
Reconcile NDC data from multiple sources
Maintain Establishment Registrations; annual recertification and as changes occur during the year
Advises manufacturing sites on requirements for third party manufacturer Establishment Registrations and liaises with third party manufacturers to ensure their Establishment Registrations are completed and up-to-date
Liaise with Supply Chain/Trade Compliance to resolve customs queries
Liaise with Sales to resolve NDC issues
Prepares GDUFA establishment registrations
Prepares SPL for Sanofi Active Ingredient Solutions (SAIS) drug listings
Requests new or reassignment of NDC labeler codes
Ensures that all SAIS entities that require an NDC labeler code are assigned an NDC labeler code
Responsible for obtaining/updating DUNS number from Dun & Bradstreet, and maintenance and biannual validation of DUNS numbers
Responsible for verification of FEIs and establishment data
SME on FDA requirements for SPL: stylesheet, document types, XML coding, etc.
Maintains plant Establishment Information in the Reed Tech Portal (for SPL)
SME-level experience and knowledge of FDA regulations and guidance's for:
o Assignment of NDC numbers/changes to NDC numbers
o Manufacturer Drug Listing for Imports
o Annual Blanket No Changes Certification
o DUNS numbers
o Establishment Registrations
o Labeler Codes
o Structured Product Labeling and Drug Listing
Understanding of the pharmaceutical industry, US bulk labeling requirements, drug listing and establishment registration.
Organizational skills: capability to work cross functionally (Industrial Affairs, CMC, Sales, Trade Compliance, etc.), coordinate discussions, and reach objectives
Must be active and demonstrate initiative: capable of carrying out multiple tasks quickly and accurately
Technical skills: Microsoft Office Suite with advanced Excel skills, Adobe Acrobat DC, XMLSpy, XML coding is a plus, Veeva, SharePoint, capacity to learn new tools, InSite for Viewing, eCTD
Ability to adapt quickly to changing priorities
Excellent oral and written communication skills
Minimum of 5-10 years as a Regulatory ERDL Coordinator, or performing all of the duties listed above, in the pharmaceutical industry. Experience working in an international environment is a plus.
Siri InfoSolutions Inc.
"s and Holders are also encouraged to apply"