- Parexel (Boston, MA)
- …motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs Senior /Consultant. This role is critical to ensure ... contingency plans for CMC -related scenarios - Represent CMC Regulatory Affairs in cross-functional...for a Consultant level role, 7+ years for a Senior Consultant - Proven success in preparing regulatory… more
- Parexel (Boston, MA)
- …strategic thinker with a passion for navigating the complex world of global regulatory affairs ? Do you thrive in cross-functional environments and love ... a dynamic and experienced Post-Approval Regulatory Strategy Lead to join our Regulatory Affairs team. In this pivotal role, you will be responsible for… more
- Parexel (Boston, MA)
- …motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs Senior /Consultant. This role is critical to ensure ... contingency plans for CMC -related scenarios * Represent CMC Regulatory Affairs in cross-functional...for a Consultant level role, 7+ years for a Senior Consultant * Proven success in preparing regulatory… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …and biomarker assay development and validation. + Collaborate with Global Manufacturing, Regulatory Affairs , and Global Quality to explore methods and implement ... and empower you to shine? Join us as a Senior Manager of Statistics- CMC in our...as appropriate in a timely manner. + Respond to regulatory questions that are statistical in nature. + Increase… more
- Bausch + Lomb (Boston, MA)
- …in assigned due diligence activities for business development and acquisitions. + Lead all CMC regulatory activities for IND, NDA, ANDA, and BLA submissions. + ... preferred + Minimum of 8 years in recent experience in strategic pharmacuetical Regulatory Affairs . This position does not work with medical device, cosmetics… more
- Parexel (Boston, MA)
- …strategic thinker with a passion for navigating the complex world of global regulatory affairs ? Do you thrive in cross-functional environments and love ... a dynamic and experienced Post-Approval Regulatory Strategy Lead to join our Regulatory Affairs team. In this pivotal role, you will be responsible for… more
- Sumitomo Pharma (Boston, MA)
- …highly motivated, and experienced individual for the position of **Associate Director, Regulatory Affairs (Oncology).** The Associate Director is part of the ... Global Regulatory Affairs (GRA) team based in the US....the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of … more
- Sumitomo Pharma (Boston, MA)
- …seeking a dynamic, highly motivated, and experienced individual for the position of **Director Regulatory Affairs ** . The Director is part of the Global ... Regulatory Affairs (GRA) team based in the...collaboration, and idea sharing + Reviews nonclinical, clinical and CMC documentation (eg nonclinical study reports, clinical protocols/study reports,… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, ... needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling,...the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory operations, etc.)… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …cross-functionally with analytical team members, process chemistry, formulation development, regulatory affairs , quality assurance, and other departments to ... drug substance and drug product ensuring compliance with relevant ICH and regulatory guidelines + Develop and implement stability study protocols and timelines,… more
- Sanofi Group (Cambridge, MA)
- …toward all GPT members, including eg project management, clinical operations, regulatory , safety, translational medicine, statistics, CMC , IA **Basic ... Global Project Head (GPH) is delegated various responsibilities by the Senior GPH and/orTherapeutic Area Head to provide leadership, supervision, and coordination… 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 ... development and enable continuous improvements without compromising quality. + Engages senior leaders and functional area stakeholders to ensure alignment of program… more
- Bristol Myers Squibb (Cambridge, MA)
- …plan (IDP) in partnership with the cross functional GPT members + Participates in regulatory filings (NDA, BLA filings) as well as develops strategy for orphan drug ... maximize program impact + Actively supports Investor Relations and Public Affairs in managing external BMS communications **Integrates commercialization inputs and… more
