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Job details

Establishment Registration Drug Listing Coordinator

About Us

LexisNexis, a part of RELX, is a leading global provider of legal, regulatory, and business information. We help customers increase productivity and improve decision-making and outcomes. Our 10,500 experts and innovative tools help us shape a better world for our customers and communities.

About the Role

As a Regulatory ERDL Coordinator, you will play a vital role in our pharmaceutical industry by providing expert-level knowledge and compliance with FDA regulations and guidelines for Establishment Registrations & Drug Listings. Your responsibilities will encompass a wide range of tasks, including preparing certifications, maintaining registrations, liaising with third-party manufacturers, and ensuring compliance with customs queries. This role requires a deep understanding of FDA regulations, drug product distribution data, and structured product labeling. If you possess strong organizational skills, technical proficiency, and excellent communication, and have relevant experience in the pharmaceutical industry, we invite you to be part of our dynamic team working in an international environment.

Conditions of Employment:

You must be a U.S. citizen to apply for this position.
You must successfully pass a background investigation and achieve Public Trust security clearance.

Responsibilities

Prepare annual Blanket No Changes Certification for Product and plant NDCs.
Maintain Establishment Registrations for all companies and plants, including annual recertification and updates as changes occur throughout the year.
Provide guidance to Industrial Affairs on requirements for third-party manufacturer Establishment Registrations and liaise with these manufacturers to ensure their registrations are completed and up to date.
Collaborate with Supply Chain/Trade Compliance teams to resolve customs queries related to regulatory affairs.
Handle the preparation of GDUFA establishment registrations.
Manage the preparation of SPL for Active Ingredient (Bulk Ingredient) drug listings.
Coordinate the registration process and fee payments for Device Establishment Registrations for customer affiliates.
Responsible for obtaining and updating DUNS numbers from Dun & Bradstreet, and ensuring their maintenance and biannual validation.
Prepare templates and verify NDCs for the Distribution Data portion of each product’s Annual Report.
Conduct quarterly verification of FEIs and establishment data for TAA reporting purposes.
Maintain plant Establishment Information in the Reed Tech Portal (for SPL).
Demonstrate expert-level knowledge of FDA regulations and guidelines related to NDC numbers, Establishment Registrations, Medical Device Establishment registrations and fees, DUNS numbers, Labeler Codes, Drug Product Distribution Data, Biannual Lot Distribution Reports, and the Trade Agreement Act (TAA reports).
Utilize technical skills in Microsoft Office Suite, Adobe Acrobat, and XML coding (a plus) to efficiently manage regulatory tasks.
Adapt quickly to changing priorities and effectively communicate with cross-functional teams, including Industrial Affairs, CMC, Pricing, and Trade Compliance, to achieve objectives.
Possess a deep understanding of pharmaceutical industry processes, drug packaging development, and labeling maintenance objectives.
Uphold excellent oral and written communication skills to facilitate clear and effective communication within the team and with external partners.
Experience as a Regulatory ERDL Coordinator, or performing all of the listed duties, within the pharmaceutical industry. International environment experience is a plus.

Requirements:

Bachelor's degree in a relevant field or equivalent work experience in the pharmaceutical industry.
In-depth expertise and comprehensive understanding of FDA regulations and guidelines related to Establishment Registrations & Drug Listings, including but not limited to NDC numbers, Establishment Registrations, Medical Device Establishment registrations and fees, DUNS numbers, Labeler Codes, Drug Product Distribution Data, Biannual Lot Distribution Reports, and the Trade Agreement Act (TAA reports).
Proven track record of as a Regulatory ERDL Coordinator, or experience encompassing all the duties mentioned above, within the pharmaceutical industry.
Familiarity with international regulatory affairs practices and working in an international environment is a plus.
Technical proficiency in using Microsoft Office Suite, Adobe Acrobat, and XML coding (knowledge of Veeva, SharePoint, and eCTD will be advantageous).
Highly organized with the ability to work cross-functionally and coordinate discussions effectively to achieve desired objectives.
Adaptability and flexibility to respond to changing priorities and business needs efficiently.
Excellent oral and written communication skills, with the capacity to articulate complex regulatory information clearly and concisely.
Demonstrated ability to work independently and as part of a team, ensuring tasks are completed accurately and in a timely manner.
A strong commitment to maintaining compliance and upholding high-quality standards in regulatory affairs.
Proactive problem-solving skills and attention to detail to navigate through intricate regulatory processes.

Work in a way that works for you

We promote a healthy work/life balance across the organization, with various flexible and remote working options available to employees

Working with Us

LexisNexis Legal & Professional is proud to be an equal-opportunity employer. We are committed to equal opportunity employment regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. Together, we are building a diverse and inclusive workplace.

Working for you

We believe in a healthy work/life balance. We know that your well-being and happiness are key to a long and successful career. These are some of the benefits we are delighted to offer:

Comprehensive, multi-carrier health plan benefits
Disability insurance
Dependent care and commuter spending accounts
Life and accident insurance

- Retirement benefits (salary investment plan/employer stock purchase plan) - Modern family benefits, including adoption and surrogacy

About our Team

LexisNexis is a data and analytics company with 10,500 colleagues serving customers in more than 150 countries. We’re one of the largest information and analytics companies on the planet. We design solutions that help our customers increase productivity, improve decisionmaking and outcomes, and be more successful.

LexisNexis, a division of RELX Group, is an equal opportunity employer: qualified applicants are considered for and treated during employment without regard to race, color, creed, religion, sex, national origin, citizenship status, disability status, protected veteran status, age, marital status, sexual orientation, gender identity, genetic information, or any other characteristic protected by law. We are committed to providing a fair and accessible hiring process. If you have a disability or other need that requires accommodation or adjustment, please let us know by completing our Applicant Request Support Form:

https://forms.office.com/r/eVgFxjLmAK

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