- Editas Medicine (Cambridge, MA)
- …cross-functional teams in the execution of these submissions. Key Responsibilities: + As the Director , Regulatory CMC , you will be responsible for: + Provide ... in the Editas regulatory affairs organization by keeping abreast of global CMC regulatory requirements and ensure that project team colleagues and management… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as a Director , Regulatory Affairs Vaccines CMC where you will provide program ... leadership and develop CMC regulatory strategy for global vaccine programs in various stages of development. You will represent the vaccine regulatory … more
- Takeda Pharmaceuticals (Boston, MA)
- …GRA CMC Pharmaceuticals, Oligonucleotides team, you will report to the Executive Director and Head, CMC Regulatory Affairs, Pharmaceuticals. **How you ... regulatory team in the development and implementation of global CMC regulatory strategies during development commercialization and post approval LCM… 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 ... with Global CMC teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives. You will also influence… 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...thorough understanding of ICH guidelines, GLP/GMP manufacturing, and related regulatory requirements is required + Ability to travel domestically… more
- Sanofi Group (Cambridge, MA)
- **Main responsibilities:** + Leads the US regulatory activities. + As a key member of the Global Regulatory Team (GRT), and strategic partner to the Global ... Regulatory Lead (GRL), the Regulatory Specialist leverages...strategy in collaboration with non-US - non-EU regions / GRA- CMC / GRA-Devices. Attends HA meetings and collaborates with… more
- Sanofi Group (Cambridge, MA)
- …the job** **Our team** The team is involved in developing and executing regulatory strategies for Tzield in life cycle development stages and post marketing to ... a later diagnosis. **Main responsibilities:** + Leads the US regulatory post-marketing activities. + As a key member of...strategy in collaboration with non-US - non-EU regions / GRA- CMC / GRA-Devices. Attends HA meetings and collaborates with… more
- Sumitomo Pharma (Boston, MA)
- …management of the global contract testing laboratories in partnership with the Company's CMC Team. The Associate Director also participates in drafting and ... **Associate Director , GMP Quality Control** Sumitomo Pharma America (SMPA)...for marketed pharmaceutical products or clinical trial materials. Review regulatory IND, IMPD, CTD and BLA/NDA CMC … more
- Novo Nordisk (Lexington, MA)
- …Development, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing ... + Work with, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams to deliver and drive the… 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
- Lilly (Boston, MA)
- …global regulatory climate and emerging requirements; ability to address key CMC regulatory questions that enable clinical studies and support marketing ... modern synthetic organic and process chemistry techniques to address key CMC challenges. + Identify scientific projects/process improvements where solutions are… more
- Novo Nordisk (Lexington, MA)
- …Non-Clinical Research, Bioanalytics, Clinical Operations, Medical Writing, Program Management, CMC and Regulatory Affairs. Interfaces with both internal ... functions such as Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC , and Regulatory Affairs to deliver and drive timely… more
- Novo Nordisk (Watertown, MA)
- …drug substance and resolve technical issues or deviations + Author and review relevant CMC sections for US and ex-US regulatory filings, including NDAs + Work ... Development - Boston and will work closely with other functions of CMC drug development, including Drug Product, Analytical Sciences, Quality Assurance, and Supply… more
- Sanofi Group (Framingham, MA)
- …Development department within CCD located in Framingham, MA in the role of Associate Director . We are looking for a candidate with excellent scientific, CMC , ... and harvest processes for clinical and commercial manufacturing + Have CMC experience covering FIH to commercial process development, process characterization, and… more
- Bristol Myers Squibb (Cambridge, MA)
- …a difference. As part of the Discovery Biotherapeutics efforts at BMS, the Senior Director of Protein Engineering will play a key role in discovering and delivering ... a first-in-class and best-in-class Biotherapeutics pipeline. The Senior Director , Protein Engineering, will be responsible for leading a team of 20+ scientists… more
- J&J Family of Companies (Lexington, MA)
- …on CMC team and to coordinates directly with Quality, Regulatory , Commercial, Formulation, Drug Product Development (DPD), Analytical Development (AD), Sourcing, ... Engineering Director , Devices - 2406181206W **Description** Johnson & Johnson...**Description** Johnson & Johnson is recruiting for an Engineering Director , Devices located in Malvern, PA, or Lexington, MA.… more
- Sanofi Group (Waltham, MA)
- …pace, working with other global project team members including physicians, regulatory leaders, CMC representatives, discovery scientists, and assay development ... Sanofi is recruiting for a Deputy Director of Clinical Immunology to support a diverse...of clinical protocols, provide scientific and technical support for regulatory communications and filings, as well as define the… more
- Lilly (Cambridge, MA)
- …improvements in healthy outcomes for our customers. We are seeking an Executive/Senior Director - DDCS Drug Delivery and New Product Innovation to partner with R&D ... the Medicines Innovation Hub and the Business Units, as well as leaders in Regulatory and Manufacturing to define and deliver our strategy. This individual will be… more
- ThermoFisher Scientific (Cambridge, MA)
- …experience in Pharmaceutical Industry, including Manufacturing, Quality Control, Quality Assurance, CMC , Regulatory or related compliance experience with at ... in the mission to holistically assess the state of quality and regulatory compliance across PSG global manufacturing/testing sites via fully independent audit… more
- WuXi AppTec (Boston, MA)
- …needs in TIDES drug development from discovery through clinical to commercial. Moreover, our Regulatory Affairs CMC team is experienced in preparing CMC ... drug). We greatly simplify the TIDES drug development by providing all discovery, CMC development and the entire manufacturing supply chain under one roof. With over… more