- Teva Pharmaceuticals (West Chester, PA)
- Senior Director Regulatory Affairs CMC (Biologic Products) Date: May 15, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva ... to make a difference with. **The opportunity** The Sr. Director , Global Regulatory Affairs CMC is responsible to oversee and help develop regulatory … more
- Takeda Pharmaceuticals (Boston, MA)
- …bring life-changing therapies to patients worldwide. Join Takeda as a Director , Regulatory Affairs Vaccines CMC where you will provide program leadership ... regulations and guidelines by applying interpersonal skills and expert Regulatory Affairs Vaccines (RAV) CMC knowledge to identify, communicate, address,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …in more than 35 countries worldwide, with headquarters in Foster City, California. **Sr Director , CMC Regulatory Affairs -Small Molecules** **KEY ... RESPONSIBILITIES** The Sr Director , CMC Regulatory Affairs for Small Molecules is responsible for managing a team of professionals, who work with… 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 ... with Global CMC teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives. You will also influence… more
- Editas Medicine (Cambridge, MA)
- …years' experience in drug development/ regulatory affairs and a minimum 8 years in CMC regulatory affairs . + Experience with both US FDA and EMA with ... execution of these submissions. Key Responsibilities: + As the Director , Regulatory CMC , you will...+ Provide CMC expertise in the Editas regulatory affairs organization by keeping abreast of… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Senior Director , Commercial Regulatory Affairs , is responsible for the development ... products in US and Canada. In addition, the Senior Director , Commercial Regulatory Affairs , in...Regulatory Affairs , in collaboration with Head, Regulatory Affairs and CMC -RA, will… more
- Ascendis Pharma (Palo Alto, CA)
- The Director , Regulatory Affairs will be responsible for developing and implementing global regulatory strategies encompassing clinical, non-clinical and ... and able to have extensive/in-depth interactions with departments outside of regulatory affairs ; ensures timely preparation of Health Authority submissions… more
- Teva Pharmaceuticals (West Chester, PA)
- Associate Director , Regulatory Affairs - Remote OR West Chester, PA Date: May 15, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: ... with. **How you'll spend your day** As the Associate Director , Regulatory Affairs you will...of the regional, clinical and Chemistry Manufacturing and Controls ( CMC ) regulatory strategies with the overall global… more
- Merck (North Wales, PA)
- **Job Description** **Position Description:** **Associate Director , Regulatory Affairs Liaison- Vaccines and Infectious Disease** The Regulatory ... as needed to colleagues in Regulatory Operations, Clinical Safety, Labeling, Regulatory Chemistry, Manufacturing and Control ( CMC ) as well as other… more
- Ascendis Pharma (Palo Alto, CA)
- …position will be based in Palo Alto, CA and reports directly to the Senior Director , Regulatory Affairs . Key Responsibilities + Responsible for strategic and ... the business, from drug development to marketing. The Manager, Regulatory Affairs will be responsible for supporting...operational regulatory input and support for cross functional ( CMC… more
- Mallinckrodt Pharmaceuticals (St. Louis, MO)
- …personnel including senior management. Organizational Relationships/Scope : The Regulatory Affairs Product Technical Specialist reports to the Director , ... Job Title Regulatory Affairs Product Technical Specialist Requisition...Prepare and publish using eCTD software well-organized, scientifically sound CMC and safety-related regulatory submissions which include… more
- Ascendis Pharma (Palo Alto, CA)
- …that are technically complex and require extensive interaction with departments outside of regulatory affairs + Must be willing to provide hands-on, study level ... 6 of those years in Oncology) + Prior Senior Management experience representing Regulatory Affairs on cross-functional teams is desirable. + Must have hands-on… 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
- Lundbeck (Deerfield, IL)
- …- Open to candidates anywhere in the greater United States** **SUMMARY:** The Director , US Regulatory Affairs Global Strategic Labelling, oversees the ... Director US Regulatory Global Strategic Labelling...Trains, develops, and manages an effective regulatory affairs cross-functional team on key labelling requirements ( CMC… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …to biologics and Oncology, incl. coordinating Reg Intelligence & Policy activities with the Regulatory - CMC function and corporate affairs as needed. In the ... working. This role will also work with the Global Regulatory Affairs Leadership Team (GRA-LT) to define...strategic objectives + Work with other DS functions (incl. Regulatory - CMC ) to coordinate Regulatory Intelligence… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio ... be responsible for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data,… more
- Sanofi Group (Cambridge, MA)
- …products within the Sanofi portfolio of products. The team is part of the Global Regulatory Affairs , Regulatory CMC and Device Department within Global ... **Job title: Device Regulatory Lead (Associate Director )** + Location:...PA or Cambridge, MA **About the job** The Global Regulatory Affairs Device team is a globally… more
- Bill and Melinda Gates Foundation (Seattle, WA)
- …of product development for our priority diseases, in the domains of regulatory affairs , quantitative sciences, chemistry manufacturing & controls, and clinical ... Bill and Melinda Gates Foundation is seeking a Deputy Director of Chemistry, Manufacturing and Controls ( CMC )...deliverability targets. + Play a strategic role in addressing CMC -related issues pertaining to regulatory interactions and… more
- J&J Family of Companies (Trenton, NJ)
- …of 2) - 2406184564W **Description** Johnson & Johnson Innovative Medicine is recruiting for a Director , Global Regulatory Affairs Leader (1 of 2) located in ... Director , Global Regulatory Leader (GRL) (1...authority regulated industry + At least 6 years of Regulatory Affairs experience required with focus on the… more
- Bristol Myers Squibb (Summit, NJ)
- …operations. The Principal PQL supports efforts to establish collaborations between Regulatory Affairs , Process Development, MS&T, Analytical Development, Site ... **Position Summary** Bristol Myers Squibb is seeking an Associate Director , Principal Product Leader within the Cell Therapy Global...+ May act as author or Quality reviewer of CMC sections of regulatory submissions and response… more