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Regulatory Affairs Specialist III (Clinical)


Location: Bridgewater, New Jersey
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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)

REQUIRED SKILLS:
• 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
EXPERIENCE:
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.

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