- Takeda Pharmaceuticals (Boston, MA)
- …of the Global Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC . **How you will contribute:** + ... therapies to patients worldwide. Join Takeda as an Associate Director , GRA CMC Small Molecules where you...where you will oversee the development and execution of regulatory CMC development and registration strategies. You… more
- Takeda Pharmaceuticals (Lexington, MA)
- …as follows: + Champions, independently develops and leads the execution of regulatory CMC investigational and/or registration strategies for assigned products as ... guide the team to define and drive strategy for CMC regulatory dossier content and reviews this...timely manner. Acts as an advisor and liaison to senior management. + As a member of the modality… more
- Takeda Pharmaceuticals (Lexington, MA)
- …their teams in the field of analytical controls and compliance + Global CMC program oversight of Pharmaceutical Sciences (PS) with management and oversight of all ... Contribute to overall functional direction globally and represent function within CMC /Pharmaceutical Science and across the global Takeda organization. + Implement… more
- Humana (Boston, MA)
- …with business partners to uphold ethical standards and mitigate risks. The Senior Clinical Compliance Professional will support the Director of Compliance, ... caring community and help us put health first** CenterWell Senior Primary Care (PCO) is a growing provider organization... focused primary care centers in 15 states. The Regulatory Compliance team that supports the PCO is responsibility… more
- Fresenius Medical Center (Waltham, MA)
- …pharmaceutical portfolio, including IND/CTAs, NDAs, NDSs, MAAs, etc..and other key regulatory submissions. + Collaborate with senior leadership in ... considerations into all stages of product development, including preclinical, clinical/medical, CMC , and post-market phases. + Monitor regulatory trends,… more
- Takeda Pharmaceuticals (Lexington, MA)
- …in leading cross-functional clinical programs within Medical Affairs, Clinical Research, Regulatory , CMC or other drug development related function. Clinical ... with significant experience within related functions (eg, Medical Affairs, Clinical Operations, Regulatory , CMC , Marketing). + Minimum of 5 years' experience as… more
- AbbVie (Worcester, MA)
- …policies and external agency regulations worldwide. Products include regulatory starting materials, Active Pharmaceutical Ingredients (API), Intermediates, and ... Global Supply Chain, Domestic and International AbbVie Plants and Affiliates, Regulatory Affairs, R&D, and PDS&T to ensure alignment Responsibilities + Support… more
- AbbVie (Cambridge, MA)
- …one aspect of Drug Development (eg, pre-clinical research, clinical development, Regulatory Affairs, Chemistry Manufacturing and Controls ( CMC )). + Experience ... an in-depth understanding of the science behind each of these opportunities. The Associate Director , Search & Evaluation will be a key member of the Specialty and… more
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