The opportunity
The RA Associate II is responsible for preparing and revising high-quality US Gx labeling documents submitted under an ANDA and/or 505(b)(2), as required. This role ensures compliance with federal regulations, guidance documents, and internal procedures while meeting deadlines aligned with company objectives.
The candidate must demonstrate the ability to work with minimal supervision and possess a thorough understanding of US FDA labeling regulations and guidance documents, applying this knowledge effectively across all work output. Additionally, they will be responsible for creating compliant Structured Product Labeling (SPL) files, ensuring complete drug listing information, and adhering to compliance requirements for importation, bulk listings, and related processes.
How you’ll spend your day
Develop US labeling documents to align with company goals and submission requirements for assigned ANDAs and/or 505(b)(2)s, 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.
Develop US labeling documents needed for early development projects requiring a human factor or comparative analysis study and ensure established 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 with all relevant departments.
Some experience in developing labeling content that requires carve-outs due to protected language associated with patents/exclusivities.
Establish and maintain SPL for assigned projects. Ensure product data elements align with the required drug listing regulations and established SPL is submitted through FDA’s Electronic Submission Gateway.
Prepare and electronically compile full responses to the FDA via the appropriate filing mode. This includes, but is not limited to, the development of side-by-side comparisons, SPL, and other required submission materials, as necessary.
Perform quality reviews of labeling and submission documents by proofreading established files for content accuracy, either manually or by utilizing the electronic proofreading tool TVT.
Work closely with external departments, including CMC and the Device team, to align with internal product/device strategy and process.
Work closely with Regulatory Operations, as well as in Teva’s publishing software, to ensure assigned projects are submitted on time following the eCTD requirements related to labeling.
Support products falling under Business Development deals, if required, from a labeling/artwork and drug listing perspective.
Attend assigned project meetings to ensure labeling timelines are met.
Maintain an accurate project tracker of all assigned projects with identified due date priorities and timelines of initial assignment, initiation, and completion of projects.
Maintain knowledge of US regulations, guidelines, and standard operating procedures applicable to US Gx labeling.
Work in a team environment with minimal supervision.
Perform all other job-related duties as required by management and dictated by process changes.
