- Teva Pharmaceuticals (West Chester, PA)
- Senior Director , Regulatory Affairs CMC , Innovative Medicine (Hybrid) Date: Mar 28, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: ... difference, and new people to make a difference with. **The opportunity** The Senior Director , Regulatory Affairs CMC is responsible to manage and help… more
- Lilly (Indianapolis, IN)
- …determined to make life better for people around the world. ** Senior Advisor/ Director , Global Regulatory Affairs - CMC , Small Molecules** At Eli Lilly, we ... new medicines to patients who need them all over the world. The Senior Advisor/ Director in Global Regulatory Affairs - CMC Small Molecules will leverage… more
- Lilly (Indianapolis, IN)
- …the world. Lilly is looking for regulatory Chemistry, Manufacturing and Control ( CMC ) scientists to join us in developing and bringing life-changing new medicines ... the project leader, you will be expected to collaborate with the broader CMC team to provide strategic, tactical, and operational support for market registrations… more
- Merck (North Wales, PA)
- **Job Description** Under general supervision of an Executive Director / Senior Director , the Principal Scientist / Director is responsible for developing ... and implementing Chemistry, Manufacturing, and Controls ( CMC ) regulatory strategies for our organization's biologics product franchises in accordance with domestic… 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 ... molecules to peptides, pediatric formulations, and devices. The Executive Director , as a senior member of the...available to patients in markets as needed. The Executive Director of CMC Pre-approval Pharm holds responsibility… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as a Director , GRA CMC Pharmaceuticals, Oligonucleotides where you will lead the GRA ... CMC Pharmaceuticals, Oligonucleotides team, you will report to the Executive Director and Head, CMC Regulatory Affairs, Pharmaceuticals. **How you will… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …product quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status and potential critical ... areas centered around rare diseases and immune disorders. **Summary** CMC Lead is responsible for supporting the overall ...CMC Lead is responsible for supporting the overall CMC strategies within projects, and manage project teams. The… more
- Frontier Medicines (Boston, MA)
- Join Frontier Medicines on an exciting journey as our newest Senior Manager/Associate Director in CMC Development, located at either our Boston or South San ... of our team, reporting directly to the Head of CMC , you'll play an integral role in advancing our...of API and preclinical formulations + Fostering collaboration with CMC and Discovery R&D teams + Conducting development studies,… more
- Takeda Pharmaceuticals (Boston, MA)
- …order to bring life-changing therapies to patients worldwide. Join Takeda as a Senior Director , GRA Pharmaceuticals- Small Molecule where you will establish ... trade associations and acts as an advisor/ liaison to senior management to plan, evaluate and recommend implementation strategy....CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs -… 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 ... Director , Analytical Regulatory Science, is responsible for supervising a...incumbent will support "right first time" global approvals for CMC control strategies and maintain "right to operate" throughout… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. **Summary** The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC ... for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data, authoring … more
- BeiGene (San Mateo, CA)
- **General** **Description:** The Senior Director of CMO and Distribution Logistics, Clinical Supply Chain is responsible for overseeing the Clinical Supply Chain ... (including but not limited to clinical Operation, Quality, Regulatory, CMC , and GRDS) to ensure alignment of organizations and...mitigation plans by working with supply chain leaders and CMC project managers. + Act as point of escalation… more
- Editas Medicine (Cambridge, MA)
- …distribution of non-GMP materials at all locations. Key Responsibilities: As the Sr. Director , Supply Chain, you will be responsible for: + Building out all aspects ... and Technical Operations and partner with leadership in TechOps, ClinOps, Finance, CMC and Program Teams to lead short-term integrated production and raw materials… 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 ... pertain primarily to marketed products in US and Canada. In addition, the Senior Director , Commercial Regulatory Affairs, in collaboration with Head, Regulatory… more
- Boehringer Ingelheim (North Brunswick, NJ)
- …Boehringer Ingelheim has a career opportunity developing pharmaceutical products as a Senior Associate Director , Analytical Development. We are looking for an ... in development. You will represent the Analytical Development function in the CMC -Technical Development Team whenever needed and pro-actively help the team to… more
- Bristol Myers Squibb (Warren, NJ)
- …the Cell Therapy Attribute Sciences group, the energetic and motivated Sr. Director will have overall responsibility for leading the development of scientific ... inform the development of manufacturing processes and analytical tools within a CMC technical development function. The dynamic leader will be tasked with… more
- Gilead Sciences, Inc. (Foster City, CA)
- …than 35 countries worldwide, with headquarters in Foster City, California. ** Senior Director , Strategic Sourcing and Supplier Management, Contracting** **KEY ... RESPONSIBILITIES** The Sr. Director , Contracting is accountable for the processes, systems, and...management systems + Understanding of activities related to the CMC development of biopharmaceuticals + Knowledge of relevant GMPs… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and Oncology, incl. coordinating Reg Intelligence & Policy activities with the Regulatory- CMC function and corporate affairs as needed. In the short term, the ... strategic objectives + Work with other DS functions (incl. Regulatory- CMC ) to coordinate Regulatory Intelligence activities and ensure regulatory/development… more
- Magellan Health Services (Honolulu, HI)
- …oriented (External and Internal). Flexible and adaptable. General Job Information Title Senior Director , Account Management- HMSA Grade 32 Work Experience - ... for building strategic relationships with customers, particularly the relationships with senior customer management, and setting and carrying out account growth and… more
- Lilly (IN)
- …and a track record of delivering impactful medicines that improve people's lives. As Senior Director DOCTA External Innovation, this role will help develop and ... and technologies in line with R&D priorities + Liaise with senior leadership and internal experts to prioritize and facilitate reviewofexternalopportunities. Perform… more