- Actalent (Boston, MA)
- …therapy experience + Must be located in EST time zone Responsibilities: + Actively represent Regulatory CMC and provide regulatory expertise as a member of ... to agency questions, and maintenance activities. + Coordinate and drive regulatory CMC submissions, including assembling necessary cross functional teams… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …Establish collaboration with Takeda teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives on drug-device ... product role in pharmaceuticals and/or medical devices industry including experience in regulatory CMC ; international experience is a plus + Experience working… more
- Takeda Pharmaceuticals (Boston, MA)
- …the Regulatory Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs - Pharmaceuticals. **How you will ... therapies to patients worldwide. Join Takeda as a Senior Director , GRA CMC Pharmaceuticals Development Portfolio Lead...CMC teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives.… more
- Takeda Pharmaceuticals (Boston, MA)
- …knowledge. **Job Description** Takeda Development Center Americas, Inc. is seeking an Associate Director , CMC Program Lead, Cell Therapies in Cambridge, MA with ... and product quality improvement in Chemistry, Manufacturing & Control ( CMC ) processes; Employ technical project management principles (project planning, RACI,… more
- Takeda Pharmaceuticals (Boston, MA)
- …a network of company Subject Matter Experts across Global R&D (Pharmaceutical Sciences, CMC Regulatory Affairs & Devices), Global Manufacturing Supply and Global ... events. + He/she must have a depth of experience in defining global Regulatory CMC strategy, superb collaboration skills, rapid, disciplined decision making and… more
- Merck (Boston, MA)
- …pivotal leadership role within the organization, overseeing the quality assurance and regulatory CMC for complex medical devices, including auto-injectors and ... **Job Description** The Executive Director , Device Quality & Regulatory will...oversight of product validation, verification, and risk mitigation activities. Regulatory CMC Oversight + Lead the preparation… more
- Merck (Boston, MA)
- …**Reports to** - Director Regulatory Compliance, Device Quality and Regulatory **Location** - Remote , Preference would be to work from Rahway, NJ, ... **Job Description** **Position Title** - Director / Principal Scientist, Regulatory Compliance **Department**...standards. + Provide strategic advice to senior management on CMC regulatory matters based on health authority… more
- Takeda Pharmaceuticals (Boston, MA)
- …to bring life-changing therapies to patients worldwide. Join Takeda as a Director , Pharmaceutical Sciences Program Leadership where you will be responsible for ... Sciences Early-Stage Portfolio team, you will report to Pharmaceutical Sciences ( CMC ) Early-Stage Portfolio Leader and mentor and cultivate best practices in… more
- Merck (Boston, MA)
- …be drivers of innovation and digitalization, as well as thought directors in CMC (Chemistry, Manufacturing and Controls) data analytics to save and improve lives. ... you will do:** You will be an advocate for CMC statistics and data science and serve as a...evaluate data for submissions and assist with replies to regulatory agencies and pharmacopoeia. You will mentor junior members… more
- Organon & Co. (Boston, MA)
- **Job Description** **The** **Position** **This position can be 100% remote in the US** The Director , Translational Medicine and Early Development (TMED) Lead ... cross-functional colleagues in preclinical science, data science, clinical operations, regulatory affairs, chemistry, manufacturing and control ( CMC ), project… more
- Merck (Boston, MA)
- …process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients ... a lead GCS Planning program representative) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines, strategies… more
- Takeda Pharmaceuticals (Boston, MA)
- …that will inspire you and empower you to shine? Join us as an Executive Director , Global Program Leader (GPL) in our Cambridge office. At Takeda, we are transforming ... versatile and strong enterprise leaders + be committed to simultaneously driving regulatory approval as well as product launch and global patient access +… more
- Takeda Pharmaceuticals (Boston, MA)
- …experience within related functions (eg Clinical Science, Clinical Operations, Research, Regulatory , CMC , Marketing) + 3-5 years program management experience ... is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy. \#LI-JT1 **Takeda Compensation and Benefits Summary** We understand… more