- PSG Global Solutions (Cambridge, MA)
- DescriptionWe're looking for an Associate Director Regulatory Affairs CMC , working in the Pharmaceuticals and Medical Products industry in Cambridge, ... Massachusetts, United States.Responsibilities:Leads development and execution of robust global regulatory CMC strategy for assigned program(s) with balanced… more
- AstraZeneca GmbH (Boston, MA)
- …is what you will do:Position SummaryThe Associate Director of Global Regulatory Affairs Chemistry, Manufacturing, and Controls (GRA- CMC ) will be responsible ... for leading and providing global CMC regulatory support for the clinical and commercial product portfolio.You will be responsible for:Job Duties and… more
- Nova Anchora (Boston, MA)
- …academic development into the clinic, we are seeking a highly skilled and experienced Senior Director of CMC to lead this critical phase of our journey. The ... Senior Director of CMC will play a pivotal...up to support later clinical studies and commercial licensure. Regulatory and Quality Compliance: Implement and manage CMC… more
- Scismic (Boston, MA)
- …that is discovering and developing novel medicines for cancer.We are seeking an Associate Director / Director of Regulatory Affairs to join the company. This ... expertise for product development including the areas of clinical research, CMC , regulatory operations, nonclinical study requirements and regulatory … more
- Monte Rosa Therapeutics (Boston, MA)
- …and self-motivated regulatory professional to join our team as an Associate Director of Regulatory Affairs. This role will focus on oncology, immunology, and ... support the global development and approval of our innovative therapies.ResponsibilitiesThe Associate Director of Regulatory Affairs will be responsible for the… more
- Dennis Partners (Boston, MA)
- …innovative therapies for people living with serious muscle diseases. They are seeking a Regulatory Affairs Director or Senior Director who can develop and ... teams and Health Authorities to advance key programs and ensure regulatory success. This company offers innovative science and a collaborative, patient-focused… more
- Vertex Pharmaceuticals (Boston, MA)
- …a compliant strategy is developed, executed, and maintained.Support preparation of CMC clinical and commercial regulatory submissions.Work closely with ... Director , Product Quality Cell and Gene (Hybrid)Job DescriptionThe...technologies, ensuring internal and cross-functional alignment with industry and regulatory expectations, and identifying product quality risks and mitigations… more
- Vertex Pharmaceuticals (Boston, MA)
- …General Summary: This Commercial Manufacturing and Supply Chain (CMSC) Director Project Management, Povetacicept (POVE) will be responsible for facilitating ... the cross-functional project teams executing our CMC and manufacturing strategies within Vertex's newly formed POVE portfolio. Povetacicept is a Phase 3 ready asset… more
- Atlas Venture (Boston, MA)
- Senior Director , Drug Product Development (Small Molecules)Company Address: 1 Winthrop Square, Suite 400, Boston, MA, 02110 About Scorpion TherapeuticsScorpion ... member of Project Development Teams, collaborate and partner closely with CMC project management, drug substance SMEs, DMPK/toxicology, clinical operations, … more
- Vertex Pharmaceuticals Incorporated (Boston, MA)
- Job DescriptionGeneral Summary:This Commercial Manufacturing and Supply Chain (CMSC) Director Project Management, Povetacicept (POVE) will be responsible for ... facilitating the cross-functional project teams executing our CMC and manufacturing strategies within Vertex's newly formed POVE portfolio. Povetacicept is a Phase 3… more
- Astria Therapeutics Inc (Boston, MA)
- …R&D activities including but not limited to, preclinical research, clinical development, CMC , regulatory affairs, new product planning, business development and ... strategies for successful development Partner closely with Research, Development, Clinical, Commercial, CMC , Regulatory Affairs and other G&A functions to ensure… more
- Xilio Therapeutics (Waltham, MA)
- …as with company policies. Accountable for development and implementation of effective CMC regulatory strategies across products and product life cycles Ensures ... Regulatory Affairs and Quality will be responsible for hiring a Director , Regulatory Operations, to report to them. Job Responsibilities: Regulatory … more
- Xenon Pharmaceuticals Inc. (Boston, MA)
- …and commercial operations. About the Role: We are seeking a Senior Manager/Associate Director , Supply Chain Planning to join our team. The Senior Manager/Associate ... Director , Supply Chain Planning will be responsible for supply...Xenon's products. The candidate will collaborate closely with the CMC and Supply Chain Management teams, as well as… more
- Actalent (Boston, MA)
- Position: Director /Sr. Director of Regulatory CMC Location: Charlestown, MA About the Role We are seeking a creative and agile regulatory ... professional to join our collaborative team as the Director /Sr. Director of Regulatory CMC . This pivotal role involves providing leadership for our… more
- Actalent (Boston, MA)
- Key Duties & Accountabilities: * Actively represent Regulatory CMC and provide regulatory expertise as a member of interdisciplinary teams (eg CMC Teams, ... to agency questions, and maintenance activities. * Coordinate and drive regulatory CMC submissions, including assembling necessary cross functional teams… more
- Takeda Pharmaceuticals (Boston, MA)
- … Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC . **How you will contribute:** + Independently ... life-changing therapies to patients worldwide. Join Takeda as a Director , GRA CMC Small Molecules where you...where you will oversee the development and execution of regulatory CMC development and registration strategies. RA… 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- Small Molecule...CMC teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives.… 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 (Cambridge, MA)
- …regulatory affairs + Has knowledge of fundamental understanding in Clinical Sciences, Regulatory CMC , DMPK, Pharmacology and Toxicology + Has ability to ... accountable for ensuring that stakeholders (including executives) are aligned; that regulatory agencies understand Takeda's CMC strategies through active… 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
