- Unknown (Boston, MA)
- …guidance to the client contact for CMC development teams. The Director will also lead regulatory intelligence activities, monitoring changes in regulations ... The Director will collaborate cross-functionally with internal teams to ensure alignment of CMC regulatory strategies with overall development plans and… more
- Takeda Pharmaceuticals (Boston, MA)
- …what is possible in order to bring life-changing therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant management ... requirements, beyond EU/US. who has an understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market… more
- Lilly (Boston, MA)
- …determined to make life better for people around the world. **Job Summary** The Director /Senior Director , CMC , Drug Product Development will lead formulation ... capabilities in drug product development and manufacturing + Author CMC sections of regulatory submissions (IND, CTA) related to drug product development and… more
- Sumitomo Pharma (Boston, MA)
- …of the product + Supports the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of regulatory strategy, and interactions ... a dynamic, highly motivated, and experienced individual for the position of **Associate Director , Regulatory Affairs (Oncology).** The Associate Director is… more
- Sanofi Group (Framingham, MA)
- **Job title** : Global Regulatory Affairs Device Lead (Associate Director ) **Location** : Morristown, NJ or Cambridge, MA or Framingham, MA **About the Job** Are ... critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse...of products. The team is part of the GRA CMC & GRA Device Department within Global R&D. The… more
- Bristol Myers Squibb (Cambridge, MA)
- …at work and in their personal lives. Read more: careers.bms.com/working-with-us . **Sr Director , Global Regulatory Strategy, Neuroscience** + Will be a key ... Leadership Team to ensure the development, implementation, and alignment of regulatory strategies across projects and the Neuroscience therapeutic area. + Acts… more
- Takeda Pharmaceuticals (Boston, MA)
- …we do begins with our commitment to putting patients first. As the Director , Technology Business Partner for Pharmaceutical Sciences R&D Data Digital and Technology ... as a strategic advisor and technology domain expert for Pharmaceutical Sciences/ CMC scientific and clinical manufacturing informatics and digital solutions +… more
- Takeda Pharmaceuticals (Lexington, MA)
- …strategy), site leadership, Technical Services, Pharmaceutical Sciences, Global Quality, and Regulatory CMC . + Provide technical support to marketing ... best of my knowledge. **Job Description** **About the role** As Associate Director , API Process Engineering, you will be Takeda's global expert for small-molecule… more
- Takeda Pharmaceuticals (Boston, MA)
- …Pharmaceutical Sciences counterparts. + Other key functional groups such as Global Quality, Regulatory CMC etc. **Leadership** + Provide vision and strategy for ... Description** **Title: Process Engineer Small Molecules API Process Science (Associate Director )** **Location: Cambridge, MA (Hybrid)** **About the role:** As a… more
- Takeda Pharmaceuticals (Boston, MA)
- …roles, with deep expertise across Pharmaceutical Sciences + Strong understanding of CMC processes, GxP, regulatory compliance and global quality standards + ... & Technology (DDT) portfolio driving innovation and operational excellence across the CMC lifecycle. This leadership role is accountable for shaping and delivering… more
- Amgen (Cambridge, MA)
- …Join us and transform the lives of patients while transforming your career. ** Director , Commercial Drug Products & Life Cycle Management** **What you will do** Let's ... leader in delivering superior, robust drug product manufacturing processes, high-quality CMC sections, and ensuring supply of commercial products. Drug Product Team… more
- Otsuka America Pharmaceutical Inc. (Waltham, MA)
- **Job Summary** The Senior Director will serve as the Translational Medicine CNS Therapeutic Area Head, reporting to the VP, Translational Medicine and Early ... Clinical Development within OPDC's Early Development Organization (EDO). The Senior Director Translational Medicine will oversee a small team of CNS Translational… more
- Bristol Myers Squibb (Cambridge, MA)
- …late-stage challenges (eg, trends in disease area therapeutic advances, and evolving regulatory , patient advocacy and market access environments) to create a vision ... for both internal and external opportunities. + Participates in regulatory filings (NDA, BLA filings) as well as develops...evidence. + Supports commercial needs and recommendations to guide CMC and GPS on trade packaging and commercial product.… more
- Alloy Therapeutics (Waltham, MA)
- …with external partners to discover and develop AntiClastic RNA medicines. The Role The Director to Executive Director of Nucleic Acid Chemistry will lead a team ... from research scale to GMP production, ensuring robustness, reproducibility, and regulatory compliance. + Implement Quality by Design (QbD) principles to establish… more
- Editas Medicine (Cambridge, MA)
- …+ Coordinate activities and deliverables across functional teams including Clinical, Non-clinical, Regulatory , CMC , and Data Management. + Track progress against ... possible in medicine, apply now. Decoding The Role: The Director , Project Management will lead the planning and execution...an aligned view of the program critical path. The Director , PM role will manage the weekly Program team… more
- Sanofi Group (Waltham, MA)
- **Job Title:** Associate Director , Genomic Medicine Purification Process Development **Location:** Waltham, MA Work Model: M-F onsite **About the Job** Are you ready ... our teams accelerate progress. The Genomic Medicine Unit (GMU) CMC group at Sanofi is dedicated to the establishment...located in Waltham, MA in the role of Associate Director . The GMU PPD group operates with the mission… more
- Takeda Pharmaceuticals (Boston, MA)
- …that will inspire you and empower you to shine? Join us as a Senior Director , Global Program Leader - Oncology, Solid Tumors in our Cambridge office. At Takeda, we ... experienced, versatile and strong enterprise leaders + Committed to simultaneously driving regulatory approval as well as launch and global patient access + Ability… more
- Takeda Pharmaceuticals (Boston, MA)
- …**Location: Cambridge, MA** **About the role:** As a Process Scientist (Associate Director ) - Global Manufacturing Science GMSci Drug Product (DP), you will provide ... and the life cycle management of existing products. You will lead regulatory interactions, including the preparation of Chemistry, Manufacturing, and Controls (… more
