- Merck & Co. (Rahway, NJ)
- … regulatory environment with potential strategic impact working closely with the Head of CMC Regulatory Policy.Performs risk assessments for determination ... managing a team of CMC professionals and ensuring high rigor in CMC regulatory strategy as well as delivery of high-quality CMC submissions for products… more
- Insmed Incorporated (Bridgewater, NJ)
- …key member of the nonclinical safety team, reporting to the Executive Director, Head of Toxicology and Molecular Mechanisms. In this role, you will represent ... oversee safety pharmacology and toxicology studies, author nonclinical sections in regulatory submission documents, and address regulatory inquiries. This… more
- Novo Nordisk Inc. (Boulder, CO)
- …new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi ... The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its...and development teams. Relationships This position reports to the Head of IP and Legal, US R&D. The role… more
- Insmed Incorporated (Bridgewater, NJ)
- …key member of the nonclinical safety team, reporting to the Executive Director, Head of Toxicology and Molecular Mechanisms. In this role, you will represent ... oversee safety pharmacology and toxicology studies, author nonclinical sections in regulatory submission documents, and address regulatory inquiries. This… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …generation, design and leadership of clinical development plans, and addressing all regulatory , drug and patient safety, data, CMC , IP, patient selection, ... cross-functional leadership abilities. The role reports to the Vice President, Head of Global Team Leaders.Responsibilities- Creating and leading a high performing,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …operates in more than 35 countries worldwide, with headquarters in Foster City, California. ** Head of CMC Regulatory Affairs - Small Molecules** **KEY ... RESPONSIBILITIES** The Head of CMC Regulatory Affairs - Small Molecules is responsible for Gilead's global portfolio of small molecule products in CMC … more
- Merck (Rahway, NJ)
- …changes in regulatory environment with potential strategic impact working closely with the Head of CMC Regulatory Policy. + Performs risk assessments for ... managing a team of CMC professionals and ensuring high rigor in CMC regulatory strategy as well as delivery of high-quality CMC submissions for products… more
- Takeda Pharmaceuticals (Boston, MA)
- … Pharmaceuticals, Oligonucleotides team, you will report to the Executive Director and Head , CMC Regulatory Affairs, Pharmaceuticals. **How you will ... regulatory team in the development and implementation of global CMC regulatory strategies during development commercialization and post approval LCM… more
- Gilead Sciences, Inc. (Foster City, CA)
- …guidelines and regulations to ensure approvability globally. The incumbent will report directly to Head of CMC Regulatory Affairs - Systems and Operations at ... to provide one CMC RA voice to PDM project teams regarding regulatory strategy and technical and quality risks. + Demonstrates success in influencing without… more
- Takeda Pharmaceuticals (Boston, MA)
- … Affairs CMC team, you will report to the Executive Director and Head , CMC Regulatory Affairs - Pharmaceuticals. **How you will contribute:** + ... Global CMC teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives. You will also influence changing… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …In addition, the Senior Director, Commercial Regulatory Affairs, in collaboration with Head , Regulatory Affairs and CMC -RA, will review and assess all ... and creating hope for all facing illness. The Senior Director, Commercial Regulatory Affairs, is responsible for the development and execution of the post-approval… more
- CSL Behring (King Of Prussia, PA)
- …our mission. o As a member of the GRA CMC Leadership Team, support the Head GRA CMC in developing regulatory infrastructure to support the function in ... a Hybrid role. You will report to the VP, Head of GRA CMC . You will provide...Health Authorities, Industry Associations) and company partners to shape regulatory CMC requirements. You will lead and… more
- Takeda Pharmaceuticals (Boston, MA)
- …Affairs Vaccines CMC where you will provide program leadership and develop CMC regulatory strategy for global vaccine programs in various stages of ... necessary, directly and indirectly. As part of the RAV CMC team, you will report to the Head...timely manner + Stay abreast of current and evolving regulatory CMC requirements, apply this knowledge to… more
- Frontier Medicines (Boston, MA)
- …South San Francisco office. As a crucial member of our team, reporting directly to the Head of CMC , you'll play an integral role in advancing our small molecule ... assessments of API and preclinical formulations + Fostering collaboration with CMC and Discovery R&D teams + Conducting development studies, interpreting results,… more
- Takeda Pharmaceuticals (Boston, MA)
- …and late-stage product development + Demonstrated experience with the preparation of analytical CMC sections of regulatory submissions + Sets a high compliance ... empowered to take charge of your future at Takeda. Join us as the Head , Analytical Development (AD) in Pharmaceutical Sciences. At Takeda, we are transforming the… more
- Sanofi Group (Framingham, MA)
- …drug substance processes on recombinant products. In cooperation with the global head of Injectables representing the Drug product part of those recombinant products ... LCM, scale up & process validation of new products transferred from CMC -Dev or next generation commercial processes. Take full accountability of Technology… more
- Sanofi Group (Framingham, MA)
- …complex change management & anchor the changes in MSAT and with connected functions, R&D- CMC , quality, regulatory . + Serve as a senior consultant on complex ... Implement Scientific board across MSAT/M&S organization and in connection with R&D- CMC for technical support and decision-making for complex topics requiring senior… more
- CSL Behring (King Of Prussia, PA)
- …used to treat serious and often rare conditions. Could you be our new Head of Global Pathogen Safety Scientific Liaison? This position is located in the King ... is a Hybrid role. You will report to the Head of Global Pathogen Safety (GPS). You will be...current scientific knowledge. Maintain the awareness of emerging and regulatory developments relating to pathogen safety science. Build partnerships… more
- Bristol Myers Squibb (Princeton, NJ)
- …all Statistical Programming deliverables. The position will be a key partner to the Head of Biostats in Cell Therapy and will assists their teams to ensure ... retention strategies for Statistical Programming for CT Stats Programming, including CMC programming in partnership / collaboration with Statistical Programming LT,… more
- Sanofi Group (Waltham, MA)
- …an integrated end-to-end mRNA vaccine capabilities and research with R&D, digital and CMC teams. Bring your ambition and optimism and join us on our journey ... about the position - About the Opportunity** The mRNA Analytical Development Head of Quality Control within mRNA Analytical Sciences Department, Center of Excellence… more
