- Sumitomo Pharma (Boston, MA)
- …agencies. + Understands evolving Health Authority (HA) standards and procedures for regulatory submissions . Guides and trains project teams on new requirements, ... of external publishing staff contracted to publish and dispatch health authority submissions . + Represents Regulatory Operations on project teams for matters… 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 ... and potential risks to inform decision-making across the organization. + **Global Regulatory Submissions :** + Oversee the planning, preparation, and execution of… more
- AbbVie (Waltham, MA)
- …enable first pass approvals. Develops and manages content strategy for regulatory submissions , including INDs/CTAs and amendments, new marketing applications ... + Prepares CMC regulatory product strategies. Prepares and manages regulatory submissions , including new applications and amendments, renewals annual… more
- Takeda Pharmaceuticals (Boston, MA)
- …strategic role in supporting the Global RA business by overseeing all PDT regulatory submissions globally to ensure proper resourcing, planning and on-time ... Responsible for overseeing the strategic planning and implementation of global regulatory submissions across PDT products. + Works closely with 3rd party vendor… more
- ConvaTec (Lexington, MA)
- …departments including but not limited to QC and legal in order to support regulatory submissions . **Travel Requirements** Position may involve travel up to 25% ... regulations and guidance documents to ensure complete and scientifically sound product submissions , as required. + Generate and execute regulatory strategies for… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …pharmaceutical and/or healthcare industry. - Knowledge and experience with preparation of global regulatory submissions (IND, CTA, NDA or BLA, MAA). - RAC ... planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment with… more
- Takeda Pharmaceuticals (Boston, MA)
- … regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with ... experience. + Preferred experience in reviewing, authoring, or managing components of regulatory submissions . + Solid working knowledge of drug development… more
- Takeda Pharmaceuticals (Boston, MA)
- … regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with ... experience. + Preferred experience in reviewing, authoring, or managing components of regulatory submissions . + Solid working knowledge of drug development… more
- Grifols Shared Services North America, Inc (Worcester, MA)
- …the scope of experimentation and the selection of data needed to support regulatory submissions . + Interacts with regulatory authorities regarding programs ... and development of contingency plans. + Ensures that technical documentation for regulatory submissions meets the appropriate standards and content requirements… more
- Takeda Pharmaceuticals (Lexington, MA)
- …and implements effective development plans. Accountabilities: + Develops, executes and oversees regulatory submissions preparation per the GRA CMC Product Team ... scientific and risk-based approach with line management. + Leads assigned global regulatory submissions (eg, Core Dossiers, INDs, CTAs, BLAs, MAAs, Variations,… more