- ConvaTec (Lexington, MA)
- …**Team** Part of a small team. Reporting to Senior Manager - International Regulatory Affairs , additional direction from Sr. Director, Regulatory ... The primary responsibilities of the position are to drive improvements in regulatory affairs processes, systems and infrastructure whilst supporting … more
- Danaher Corporation (Boston, MA)
- …Business Syste m (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Senior Principal, Regulatory Affairs is ... and digital pathology in the clinical oncology environment. The Senior Principal, Regulatory Affairs will...internal procedures are updated to reflect evolving US and international regulations. + Assess the impacts of relevant drug… 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 GRA ... and other unique modalities + Represents, contributes and influences Regulatory , Pharmaceutical Development, and Commercial project teams throughout clinical… more
- Medtronic (Mansfield, MA)
- …innovation in a more connected, compassionate world. **A Day in the Life** The Senior Regulatory Affairs Specialist (Sr. RAS) is responsible for ... development and review process + Provide business and product information to the international regulatory affairs team to enable development and strategies… more
- Takeda Pharmaceuticals (Boston, MA)
- …to bring life-changing therapies to patients worldwide. The Associate Director, Global Regulatory Affairs Advertising and Promotion (GRA A&P) Review Lead is ... medicine promotion. **How you will contribute:** + As our Associate Director, Global Regulatory Affairs Advertising and Promotion lead you will act as the… more
- 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:** + Plan, ... GRA CMC Small Molecules where you will oversee the development and execution of regulatory CMC development and registration strategies. You will be RA CMC member on … more
- Fresenius Medical Center (Waltham, MA)
- …(Advanced degree such as a Master's, PhD, or MBA is highly preferred). + Regulatory Affairs Certification (eg, RAC) is preferred. + **Experience:** + 12+ years ... portfolio, including IND/CTAs, NDAs, NDSs, MAAs, etc..and other key regulatory submissions. + Collaborate with senior leadership...of experience in regulatory affairs , focusing on regulatory … more
- Sumitomo Pharma (Boston, MA)
- …The Director, Medical Strategy (Prostate Cancer) will be a key member of the Medical Affairs team reporting to the Senior Director, Medical Affairs Strategy. ... initiatives and advance patient advocacy efforts to ensure that Medical Affairs activities align with patient focused programs. **Job Duties and Responsibilities**… more
- Veterans Affairs, Veterans Health Administration (Leeds, MA)
- …and procedure. To perform this task, they must possess expertise in International Classification of Diseases (ICD), Current Procedural Terminology (CPT), and the ... services. Selects and assigns codes from the current versions of the International Classification of Diseases (ICD) Clinical Modification (CM) and Procedure Coding… more
- Sumitomo Pharma (Boston, MA)
- …Manager of Regulatory Operations is responsible for managing all Regulatory Affairs activities involving compilation, publishing, distribution, and archiving ... seeking a dynamic, highly motivated, and experienced individual for the position of Senior Manager, Regulatory Operations, For assigned projects, the Senior … more