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Title : SG-Regulatory Affairs Specialist III -018
State : New Jersey   Date : May 17, 2021
Experience Level :  
Position Type : Regulatory Affairs Specialist III      
Description
This position is for a leading pharmaceutical company. Below are the details of the engagement. If you are available and interested please send me your updated word resume & your expected hourly rate on W2 ASAP.
Looking forward to hearing from you soon.

Work Location: Remote

Job Title: Regulatory Affairs Specialist III

Duration: 10+ months (extendable) contract on W2


Duties:

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 the Client's 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)
Skills (Required):

  • SME-level experience and knowledge of FDA regulations and guidance’s for:
  1. Assignment of NDC numbers/changes to NDC numbers
  2. Manufacturer Drug Listing for Imports
  3. Annual Blanket No Changes Certification
  4. DUNS numbers
  5. Establishment Registrations
  6. Labeler Codes
  7. 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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Many Thanks,   

Sree Kanth
Recruitment Manager
Sree@newageclinical.com

NewAgeSys, Inc.
Direct: 609-945-1736 Fax: 609-228-4079
600 Alexander Rd, Suite 3-3 
Princeton , NJ 08540 
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