- Takeda Pharmaceuticals (Lexington, MA)
- …life-changing therapies to patients worldwide. Join Takeda as an Associate Director , Global Regulatory Affairs CMC where you will develop and lead the ... execution of regulatory CMC investigational, registration and/or post-approval strategies...CMC team, you will report to a Senior Director and work with stakeholders across the business. **How… more
- Lundbeck (Deerfield, IL)
- Director Global Regulatory Affairs CMC - Remote Opportunity Requisition ID: 5582 Location: Deerfield, Illinois, US Do you want to join a team where the ... of the product (IND/CTAs, NDAs/BLAs, Marketing applications). This role will provide CMC regulatory support and guidance for assigned projects and interfaces… more
- Gilead Sciences, Inc. (Foster City, CA)
- …countries worldwide, with headquarters in Foster City, California. **About the Role:** The Senior Director , CMC Regulatory Affairs for Biologics is ... product in Gilead's global portfolio of biological products in CMC Regulatory Affairs . This position...by maintaining the global licensures. In addition, the Sr Director will be accountable for leading the interpretation and… more
- Takeda Pharmaceuticals (Boston, MA)
- … CMC team, you will report to the Senior Director Global Regulatory Affairs CMC . **How you will contribute:** + Independently plan, execute and ... life-changing therapies to patients worldwide. Join Takeda as a Director , GRA CMC Small Molecules where you...where you will oversee the development and execution of regulatory CMC development and registration strategies. RA… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …to build/maintain database to address external questions regarding drug products. The CMC Regulatory Associate Director , Biologics is responsible for ... a products lifecycle. Members of the organization develop global regulatory CMC strategies and partners with key...HA meetings); and/or post-approval submissions. In this role, the GRS- CMC Associate Director , Biologics will serve as… more
- Takeda Pharmaceuticals (Boston, MA)
- … CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs - Pharmaceuticals. **How you will contribute:** + Leads the ... therapies to patients worldwide. Join Takeda as a Senior Director , GRA - CMC Pharmaceuticals- Small Molecule...CMC teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives.… more
- Gilead Sciences, Inc. (Foster City, CA)
- …be accountable for the interpretation and implementation of new and existing CMC regulatory guidelines and regulations to ensure approvability globally. ... Gilead and help create possible, together. **Job Description** The Associate Director , Analytical Regulatory Science, collaborates with product development,… more
- Organon & Co. (Plymouth Meeting, PA)
- **Job Description** **The Position** Reporting to the Director or Executive Director in Organon Regulatory CMC New Products, the Associate Principal ... Scientist (Associate Director ) is responsible for Regulatory Chemistry Manufacturing & Controls ( CMC ) aspects of clinical phase through market product… more
- Amicus Therapeutics (Marlow, OK)
- Director , CMC RA Location Marlow, UK...matter experts in Tech Ops, Science, Quality and Global Regulatory Affairs to ensure timely delivery of ... and ensuring seamless communication. The incumbent will manage, prepare & execute the CMC regulatory strategy for technology transfer of small and large molecule… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …including working with contract manufacturing organizations CMO.** This position serves as the Regulatory Affairs (RA) CMC project representative to the ... years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience or + PhD. with 6-8 years pharmaceutical industry experience… more
- Ascendis Pharma (Palo Alto, CA)
- …a dynamic workplace for employees to grow and develop their skills. The Associate Director , Regulatory Affairs will be responsible for developing and ... implementing global regulatory strategies encompassing clinical, non-clinical and CMC ...complex and require extensive interaction with departments outside of regulatory affairs . + Excellent organizational skills and… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Senior Director , Regulatory Affairs - Clinical (Neuroderm), may be called ... to facilitate timely drug development and registration. The Senior Director , Regulatory Affairs - Clinical...support marketing product claims. + Acts as liaison between Regulatory Affairs & CMC and… more
- Amgen (Washington, DC)
- …10 million patients worldwide. It's time for a career you can be proud of. ** Regulatory Affairs Director - Global Regulatory Leader (General ... time for a career you can be proud of. ** Regulatory Affairs Director - Global...filings (eg clinical trial applications, marketing applications, label extensions, CMC changes) + Ensure consistency of evidence-based global product… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Director , Regulatory Affairs (Early Development) provides strategic global ... in the rare disease space. In this role, the Director defines and implements regulatory strategies; works...requests, and briefing documents. + Acts as liaison between Regulatory Affairs and other functional areas, including… more
- Boehringer Ingelheim (Ridgefield, CT)
- …or more therapeutic areas covering multiple dosage forms while interacting effectively within Regulatory Affairs and across CMC stakeholder functions, as a ... Scientific Communications, clinical operations, translational medicine and clinical pharmacology, and regulatory affairs . This position will require the Fellow… more
- Danaher Corporation (Raleigh, NC)
- … Affairs department and report to the Vice President of Global Quality and Regulatory Affairs . The Director of Global Regulatory Affairs ... human health. This position is part of Quality and Regulatory Affairs located in Fargo, ND and...the authoring, review and support of client filings including CMC submission in INDs, BLAs, NDAs, etc. + Primary… more
- Organon & Co. (Lansdale, PA)
- …**The Position** Reporting to the Executive Director in Organon's Regulatory Chemistry, Manufacturing and Controls ( CMC ) New Products, the Senior ... for the preparation and review of information required for development of regulatory CMC dossiers for commercial products. Primary responsibilities include, but… more
- Ascendis Pharma (Palo Alto, CA)
- …all aspects of the business, from drug development to marketing. The Senior Manager, Regulatory Affairs will be responsible for supporting and developing global ... Alto, CA and reports directly to the Head of Regulatory Affairs . Key Responsibilities + Responsible for.... Key Responsibilities + Responsible for strategic and operational regulatory input and support for cross functional ( CMC… more
- Gilead Sciences, Inc. (Foster City, CA)
- …regulations to ensure approvability globally. The incumbent will report directly to Head of CMC Regulatory Affairs - Systems and Operations at Gilead. **JOB ... more than 35 countries worldwide, with headquarters in Foster City, California._ **Senior Director - Analytical Regulatory Science** KEY RESPONSIBILITIES The Sr … more
- Lilly (Indianapolis, IN)
- …for people around the world. Purpose: The purpose of the Senior Director /Executive Director , Global Regulatory Affairs , Global Regulatory Lead (GRL) ... regulatory excellence attributes as described in Global Regulatory Affairs white papers. + Participatein forumsthatshareregulatoryinformationacrossGRA… more