7 pharmaceutical jobs found

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH.   Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c).   Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To...

Regeneron Pharmaceuticals, located in Sleepy Hollow NY, is seeking a Manager, Tax Operations . In this role you will report to Director of Tax Operations in support of Regeneron’s overall tax initiatives through preparation of financial statements, tax returns and other compliance related tasks. As Manager, Tax Operations a Typical Day May Include: Corporation Income Tax Returns: Manage corporate income/franchise taxes, including tax return preparation process supporting schedules and other analyses, as required. Responsible for accurate and timely filing of all returns, extensions, estimates and payments of taxes, as applicable. Tax Accounting under ASC740: Reconciliation of tax accounts, preparation of corporate tax provisions (book and tax) and preparation of income tax disclosures for publicly issued financial statements. Manage state and local tangible property tax returns and other business filings in which an obligation exists to file. Analysis of Tax Legislation...

Summary: Responsible for assisting management with ensuring auditors have the education, experience and/or training necessary to be able to perform audits, and assisting with the maintenance and continuous improvement of the auditor training program. Responsible for planning, coordinating and performing pre-, during and post-audit activities for assigned audits. Extensive knowledge of USA and EU GxP regulations is required. Essential Duties and Responsibilities include, but are not limited to, the following: Maintain professional expertise and knowledge of audit criteria including, but not limited to, internal company policies and procedures, and applicable local and international regulations, standards and guidelines (e.g., Chapter 21 of the Code of Federal Regulations, Eudralex Volume 4 and associated Annexes, ISO Standards, and ICH, WHO and IPEC Guidelines, etc.); Monitor industry trends with respect to regulatory agency findings, expectations and warning letters;...

The Senior Manager Accounting will be responsible for management of the Inventory Accounting team based in Limerick in connection with the Company’s biopharmaceutical manufacturing operations in Limerick and International entities. A typical day might include, but is not limited to, the following:  Reporting of monthly actual results for inventory for the international entities Responsible for Profit in Inventory Elimination for international entities Reviewing and handling the company’s inventory and standard cost system including annual standards' development Reviewing and maintaining company’s inventory and standard cost system Oracle Process Manufacturing Working with Master Data Management to ensure production Recipes / BOM’s are accurate and are reflected in the Standard Costing calculations Reviewing Sub Ledger (Production, Inventory, Purchasing, Revaluation, Order Management) Responsible for coordination and review of quarterly inventory...

Within this role you will be responsible for planning, coordinating and performing pre-, during and post-audit activities for assigned audits. You will be responsible for assessing systems, processes, procedures and records against applicable U.S. and ex-U.S. GxP regulations, with primary emphasis on GMP, IT and Quality audits that may impact Regeneron operations and/or product. Note this position requires approximately 50% travel globally. As a GMP Quality Auditor, a typical day might include, but is not limited to, the following:   Maintaining professional expertise and knowledge of audit criteria including internal company policies and procedures, and applicable local and international regulations, standards and guidelines (e.g., Chapter 21 of the Code of Federal Regulations, Eudralex Volume 4 and associated Annexes, ISO Standards, and ICH, WHO and IPEC Guidelines, etc.) Supervising industry trends with respect to regulatory agency findings, expectations and...

As a GMP Quality Auditor you will be r esponsible for planning, coordinating and performing pre, during and post-audit activities for assigned audits. You will be responsible for assessing systems, processes, procedures and records against applicable U.S. and ex-U.S. GxP regulations, with primary emphasis on GMP, IT and quality audits that may impact Regeneron operations and/or product. A typical day might include, but is not limited to, the following:   Maintaining professional expertise and knowledge of audit criteria including, but not limited to, internal company policies and procedures, and applicable local and international regulations, standards and guidelines (e.g., Chapter 21 of the Code of Federal Regulations, Eudralex Volume 4 and associated Annexes, ISO Standards, and ICH, WHO and IPEC Guidelines, etc.) Supervising industry trends with respect to regulatory agency findings, expectations and warning letters Performing supplier/external audits and...

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH.   Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c).   Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To...