- Merck (North Wales, PA)
- …+ In depth knowledge and application of global CMC guidelines regarding IND/BLAs or post approval changes. + The CMC Project Lead is accountable for the ... Manage execution of CMC documentation including IND/CTA, original BLA/MAA, or Post Approval Life Cycle, including agency background packages and response to… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …individual will be responsible for working on cross-functional teams, developing and executing post - approval Regulatory CMC strategies, reviewing CMC ... Harmonization (ICH), and other applicable regulations. This includes preparation, review, and approval of CMC documentation for BLA Supplements (PAS, CBE-0,… more
- Merck (Rahway, NJ)
- …while developing and expanding your career. The Chemistry, Manufacturing & Controls ( CMC ) Pre- approval Pharm Executive Director is accountable for managing a ... patients in markets as needed. The Executive Director of CMC Pre- approval Pharm holds responsibility for overseeing...small molecules, peptides, pediatric formulations, and devices. As a senior figure within the GRACS CMC Organization,… more
- BeiGene (Emeryville, CA)
- …ensure on-time and high- quality global submissions for investigational, market, and post - approval applications. . Develop regulatory strategy and execute in the ... + A proven record of leading Health Authority interactions, CTA, NDA/MAA, post - approval preparation, submission, and subsequent response to HA queries. +… more
- Lilly (Indianapolis, IN)
- …seeking Regulatory Scientist GRACMC-Biotechnology to be a part of the Lilly post - approval regulatory group to support global submissions and registrations. As ... provide strategic, tactical, and operational support for market registrations and post - approval submissions. The regulatory scientist in Global Regulatory… more
- Lilly (Indianapolis, IN)
- …people who are determined to make life better for people around the world. ** Senior Advisor/Director, Global Regulatory Affairs - CMC , Small Molecules** At Eli ... life-changing new medicines to patients who need them all over the world. The Senior Advisor/Director in Global Regulatory Affairs - CMC Small Molecules will… more
- Takeda Pharmaceuticals (Boston, MA)
- …of global CMC regulatory strategies during development commercialization and post approval LCM stages. Combine knowledge of scientific, regulatory and ... CMC requirements relevant to global drug development and post -market support. + Experience providing strategic regulatory guidance to drug development,… more
- Takeda Pharmaceuticals (Boston, MA)
- …to assure regulatory conformance prospectively and retrospectively for products in the post - approval space. + Work closely with colleagues in quality and ... and bring current products to industry standards. + Represent CMC and GRA on key governance committees and play...of new technologies and molecules. + Lead and mentor senior individuals with varying backgrounds, enabling them to hire,… more
- Kedrion Biopharma, Inc. (Fort Lee, NJ)
- …Product Owners (GPOs) to prepare technical sections of US dossiers of post - approval supplements (annual reports, LDRs, PSURs, promotional material and ... US regulatory activities. + Familiar with FDA regulation and guidelines for post - approval change management. + Familiar with ICH guidelines. + Experience… more
- Boehringer Ingelheim (New Brunswick, NJ)
- …Authorities in various regulatory processes, eg geographical expansion of existing products, post approval changes on existing registrations. + Lead strategy ... Program Leader + Responsibilities include: + Operations Lead (by topic) of CMC Development sub-team + Technical guidance and recommendation for user requirements,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …more than 35 countries worldwide, with headquarters in Foster City, California._ ** Senior Director - Analytical Regulatory Science** KEY RESPONSIBILITIES The Sr ... analytical control strategies in regulatory submissions preparation, review and approval . By balancing analytical knowledge and evolving regulatory expectations with… more
- Organon & Co. (Jersey City, NJ)
- …and review of CMC submission components and documentation to support post - approval supplements, annual reports, registration renewals and responses to health ... Position** Reporting to the Director in Regulatory Chemistry, Manufacturing & Controls ( CMC ), the Senior Scientist is responsible for implementing Regulatory… more
- Takeda Pharmaceuticals (Boston, MA)
- …of global CMC regulatory strategies during development ,commercialization and post approval LCM stages + Combines knowledge of scientific, regulatory ... to bring life-changing therapies to patients worldwide. Join Takeda as a Senior Director, GRA Pharmaceuticals- Small Molecule where you will establish collaboration… more
- Lundbeck (Deerfield, IL)
- …Provides regulatory expertise and strategic direction for the development and post - approval maintenance of global labelling, influencing cross functional ... Senior Director US Regulatory Global Strategic Labeling -...registration regulatory strategies to ensure the successful development and approval of assigned drug and biological products. Manages team… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …leads, develops, and implements strategic and tactical support for commercial, post approval regulatory activities for successful and compliant promotion ... Regulatory Affairs, is responsible for the development and execution of the post - approval regulatory strategy, post -marketing commitments, post -marketing… more
- AbbVie (Irvine, CA)
- …material suppliers, reduce cost and/or enhance the intellectual property landscape. + Support CMC life cycle management and post - approval continued process ... in AbbVie. We have an exciting opportunity for a Senior Scientist position based in Irvine, CA. The scientist...of affected product lots. + Author and review relevant CMC sections of submissions and support agency inspections, inquiries… more
- AbbVie (Irvine, CA)
- …material suppliers, reduce cost and/or enhance the intellectual property landscape. + Support CMC life cycle management and post - approval continued process ... in AbbVie. We have an exciting opportunity for a Senior Scientist II position based in Irvine, CA. The...of affected product lots. + Author and review relevant CMC sections of submissions and support agency inspections, inquiries… more
- AbbVie (Irvine, CA)
- …regulatory approvals including CE mark, US PMAs, US IDEs, US 510(k), post - approval reports, annual reports, export certificates, establishment registrations and ... into the preparation and maintenance of chemistry, manufacturing, and controls ( CMC ) device sections of regulatory submissions, responses to Agency questions for… more
- Amgen (Cambridge, MA)
- …worldwide. It's time for a career you can be proud of. Process Development Senior Principal Scientist **Live** **What you will do** Let's do this. Let's change the ... within the analytical sciences space. + Author chemistry, manufacturing and controls ( CMC ) sections in regulatory files, lead the preparation of responses to… more
- Takeda Pharmaceuticals (Boston, MA)
- …analytical testing capabilities in line with Takeda's R&Dportfolio from discovery to post approval .This position will also determine and support new areas ... strategies) and is responsible for the management of all CMC analytical testing activities for the global R&D portfolioincluding...world that will serve as the basis for marketing approval . + Develops and implements strategies to reliably control… more