8 Lorenz Jobs

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a w...

8+ years of Regulatory Operations and Regulatory Information Management experience. Knowledge of drug development and approval process. Global R&D submission process and requirements including eCTD publishing principles and various application types.

Regulatory Affairs Executive : (BKM) is seeking a Regulatory Affairs Executive to join our team. In this role, you will be responsible for getting new products approval from the regulated market. In-depth knowledge of US FDA, EMA, and ICH regulatory frameworks, eCTD/ACTD dossier preparation, compilation and submission. Familiar with regulatory tools like Extedo, Lorenz, Veeva Vault RIM Job Responsibility : Prepare, compile, and review eCTD dossiers for submissions (e.g., ANDA/NDA /MAA/ANDS). Coordinate with cross-functional teams (QA, QC, R&D, Manufacturing, Packaging) for accurate documentation. Submit applications to US FDA, HC, EMA, and other authorities in compliance with regional requir...

Role Overview: As a Quality Assurance (QA) Associate specializing in Corrective and Preventive Actions (CAPA), Audits, and Inspections, you will play a critical role in ensuring compliance and continuous improvement within GMP-regulated environments in the Life Sciences industry. Your primary focus will be managing CAPA processes, supporting audits, and preparing for regulatory inspections to maintain adherence to standards such as GMP, ISO, and ICH guidelines. Key Responsibilities: - Manage Corrective and Preventive Actions (CAPA) by initiating, tracking, and closing CAPA records in alignment with quality objectives. - Conduct root cause analysis using tools like 5 Whys, Fishbone, or Six Si...

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a w...

Handled ANDA submissions with thorough knowledge on review of CMC documents of dosage: Injectables (simple and complex), Ophthalmics, Topicals, Nasal Sprays and Tablets. knowledge on Module 5 requirements with review & upload study reports. Required Candidate profile Experience of eCTD tools - Educe/Lorenz and/or Pharma Ready. evaluate and respond Agency’s Deficiencies. review DMF. USFDA. Experience of handling submissions related to site transfer products

Title: Senior Submission Publisher Business Unit: Regulatory Operations Global Regulatory & Business Continuity Innovative Medicines Job Grade G10 / Manager Location : Mumbai (preferred) / Gurgaon / Baroda Key Responsibilities At Sun Pharma, we commit to helping you Create your own sunshine by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine As you enter the Sun Pharma world, you'll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we T...

You have hands-on experience working with the US, Canada, and European Market regions in regulatory publishing and submissions. Your expertise includes managing dossiers, using Lorenz, and working with Docubridge. As a Submission Publisher, you will be responsible for regulatory submissions related to the pharmaceutical industry. This is a full-time, permanent role in the ITES/BPO/KPO sector, specifically within the functional area of pharmaceuticals. You should be well-versed in handling dossiers, using Lorenz software, and working with Docubridge. The job code for this position is GO/JC/20989/2025. Your recruiter for this role is HariharanA.,