Regulatory Affairs Associate II (Labeling)

Who we are

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

The opportunity

The Regulatory Affairs Associate II, Labeling is responsible for the development and/or revision of high-quality US Gx labeling documents filed under an ANDA and/or 505(b)2, if required, while ensuring adherence to federal regulations and meeting deadlines driven by company goals.

 

Occasional travel required (10% Local/Domestic)

Location: Parsippany, NJ (Hybrid Schedule)

How you’ll spend your day

• Developing and electronically compiling labeling documents to align with company goals and submission requirements for assigned ANDAs and/or 505b2s, if required, and ensure labeling meets all legal and regulatory requirements.  This includes QC, proofing, editing and formatting of documents, and coordinating the review and approval of final submission documents.
• Establishing SPL for assigned projects to ensure product data elements align with the required drug listing regulations and established SPL is submitted through FDA’s Electronic Submission Gateway.
• Creating, revising, and preparing labeling documents needed for full responses to FDA via appropriate filing mode (including development of side-by-side comparisons, SPL, and other required submission materials, as necessary.)
• Perform quality reviews of labeling and submission documents.
• Working closely with external departments, including CMC team(s) and device team(s), to align with internal product/device strategy.
• Working with Regulatory Operations, in the US and in India, or Regulatory Affairs CMC by uploading all labeling documents, for scheduled submissions, into the electronic publishing tool while ensuring the submission is completed on-time following the eCTD requirements related to labeling.
• Supporting products falling under Business Development deals from a labeling/artwork and drug listing perspective.
• Maintaining an accurate project tracker of all assigned projects with identified due date priorities and timelines of initial assignment, initiation, and completion of projects; and attending assigned project meetings to ensure labeling timelines are met.
• Maintain knowledge of regulations, guidelines, and standard operating procedures applicable to Gx labeling.

Your experience and qualifications

Required:

• Bachelor's Degree in a scientific-related field or equivalent combination of education and Gx labeling experience in a Regulatory environment.
• 3 years of pharmaceutical industry experience, specifically in Regulatory Affairs, with a focus on Gx labeling (including knowledge of SPL development and FDA drug listing requirements, and experience using Adobe Acrobat Professional.)

 

Preferred:

• Knowledge of FDA US regulations and guidance’s related to US Gx labeling
• Knowledge of FDA eCTD submission standards and experience in applying these requirements to routine labeling submissions to FDA
• Knowledge of TVT

Enjoy a more rewarding choice

We offer a competitive benefits package, including Medical, Dental, Vision, and Prescription coverage starting on the first day. We also offer Disability and Life Insurance, Paid Time Off, 13 paid Holidays, 6% match on the 401(k), Employee Stock Purchase Plan, and Tuition Assistance.

Reports To

Manager, Regulatory Affairs

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