The opportunity
The RA Associate III is responsible for preparing and/or reviewing 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 independently and possess a strong knowledge 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 for early development projects requiring a human factor or comparative analysis study to 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 documents with all relevant departments.
Develop labeling content that requires carve-outs due to protected language associated with patents/exclusivities.
Serve as a Subject Matter Expert (SME) in all facets of SPL/drug listing, including but not limited to finished product, bulk, and manufacturer under contract. The SME must be able to provide guidance to other team members related to established SPL documents (content and data elements) to ensure alignment with associated applications and applicable FDA regulations and guidance, as well as troubleshoot any validation errors received.
Work closely with the SPL Vendor, as well as the FDA Drug Listing team, on any drug listing issues, ensuring a rapid resolution.
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 the CMC and Device teams, to align with internal product/device strategy and processes.
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.
Provide support to the Manager, as needed, in completing the year-end FDA Mandated Blanket No Change certification. This ensures all drug product listings remain active within the agency's National Drug Code (NDC) Directory, preventing potential issues such as disruptions in the market, Medicaid rebates, and other regulatory complications.
Assist in the training of new labeling personnel.
Maintain knowledge of US regulations, guidelines, and standard operating procedures applicable to US Gx labeling and drug listing.
Work in a team environment.
Perform all other job-related duties as required by management and dictated by process changes.
