Regulatory Affairs Associate III Teva Pharmaceuticals

6.0 - 10.0 years

0 Lacs

maharashtra

On-site

As a Labeling Specialist in the Pharmaceutical Industry, you will be responsible for developing US labeling documents to align with company goals and submission requirements for assigned ANDAs and/or 505(b)(2)s. Your role will involve ensuring that labeling meets all legal and regulatory requirements through QC, proofing, editing, and formatting of documents. You will coordinate the review and approval of final submission documents with all relevant departments. Your expertise will be crucial in developing labeling content that requires carve-outs due to protected language associated with patents/exclusivities. Serving as a Subject Matter Expert (SME) in SPL/drug listing, you will provide guidance to other team members related to established SPL documents to ensure alignment with associated applications and FDA regulations. You will also work closely with the SPL Vendor and FDA Drug Listing team to resolve any listing issues promptly. Preparing and compiling full responses to the FDA via the appropriate filing mode will be a key aspect of your role. This includes developing side-by-side comparisons, SPL, and other required submission materials. You will perform quality reviews of labeling and submission documents, ensuring content accuracy and compliance with regulations. Collaboration with external departments such as CMC and Device teams is essential to align with internal product/device strategy and processes. You will also work with Regulatory Operations to ensure timely submission of assigned projects following eCTD requirements related to labeling. Supporting products falling under Business Development deals and attending project meetings to meet labeling timelines will be part of your responsibilities. Maintaining an accurate project tracker and providing support for FDA Mandated Blanket No Change certification are also key tasks. Additionally, you will assist in training new labeling personnel and stay updated on US regulations, guidelines, and standard operating procedures applicable to US Gx labeling and drug listing. To qualify for this role, you should have 7-9 years of experience in the Pharmaceutical Industry with a minimum of 6+ years in RA. A degree in Pharmacy or Life Sciences is required. Proficiency in US FDA regulations, eCTD submission standards, and software such as Adobe Acrobat Professional is necessary. Strong multitasking abilities and teamwork skills are essential for success in this fast-paced environment. If you meet these qualifications and are eager to contribute to our team, please share your CV to ankita.sonawane@teva.co.in. We look forward to reviewing your application and potentially welcoming you to our dynamic team.,

Posted 2 weeks ago

Apply

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.