Regulatory Affairs Associate II, Labeling Date: May 13, 2025 Location: Navi Mumbai, India, 400706 Company: Teva Pharmaceuticals Job Id: 61885 **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 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. **Your experience and qualifications** + Pharma Graduate / Postgraduate with a Scientific or Regulatory background or equivalent combination of education and experience + 3+ years of pharmaceutical industry experience, specifically in Regulatory Affairs with a focus on US Gx labeling and drug listing. + Knowledge of SPL development and US FDA drug listing requirements. + Bachelors in Pharmacy/Master in science & Life sciences- 4-5 Years in the Pharmaceutical Industry. + Master in Pharmacy-3-4 Years in the Pharmaceutical Industry. + Proven experience in regulatory affairs within the pharmaceutical, biotechnology, or medical device industry. **Teva’s Equal Employment Opportunity Commitment** Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience. EOE including disability/veteran