Regulatory ERDL Coordinator (S018)

  • Contract Duration: 10 months, Remote until allowed onsite
  • Research & Development
  • Bridgewater, NJ (Remote)

Website Lenox Executive Search

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
• Requests new or reassignment of NDC labeler codes
• Ensures that all SAIS entities that require an NDC labeler code are assigned an NDC labeler
• 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
• 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

Upload your resume here.

Our COVID-19 Policy

As with other larger employers and customer-facing organizations, Lenox Executive Search is carefully monitoring the situation regarding Coronavirus (COVID-19), with a particular focus on public health guidance offered by the CDC and state officials.  We are reaching out to make you aware of our activities and preparations in light of the spread of the Coronavirus (COVID-19). Our number one priority is the safety of our employees, clients and the broader community. Given the current unpredictable nature of the spread of COVID-19, and in an abundance of caution, Lenox Executive Search has implemented the following practices immediately:
  • We have increased our overnight cleaning activities to ensure frequently touched areas are being disinfected and sanitized.
  • We have implemented social distancing techniques to minimize the typical face-to-face- contact by utilizing teleconference calls and flexible workspaces.  We have suspended non-essential business travel for our employees and have asked that inter-company meetings be conducted via teleconference. In addition, we kindly ask all of our customers to help us maintain a handshake-free zone at all Lenox Executive Search locations.
  • We have asked employers who feel ill to stay home.
  • We have convened a team of senior leaders who meet daily to discuss the situation and stand ready to take additional steps, if necessary.
  • We have measures in place to ensure our operations can effectively continue so that we can provide our clients uninterrupted service.  Lenox Executive Search already had robust and detailed business continuity plans in place.
– The Lenox Executive Search Team