- Daiichi Sankyo, Inc. (Bernards, NJ)
- …quality, reliability, consistency and efficiency.ResponsibilitiesPlan, coordinate, and review US regulatory submissions in collaboration with USRL, Regulatory ... FDA forms, administrative information, letter of authorization, etc.) for US regulatory submissions .Support FDA meeting preparation including preparation of… more
- Eisai, Inc (Exton, PA)
- …strategies throughout the lifecycle of pharmaceuticals. Coordinates the preparation of CMC regulatory submissions that meet global regulatory requirements, ... to improve efficiency. Essential Functions 1. Development Projects Assumes CMC regulatory accountability for clinical development documents (INDs, IMPDs, and CTAs)… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …provides guidance to ROI staff as needed during assembly of regulatory submissions .Advertising and PromotionGain understanding of how prescription drug ... required documents to FDA.RelationshipsThe fellow will report to the fellowship track manager within the Regulatory Affairs - Therapeutic Area team throughout… more
- Aequor (Tallahassee, FL)
- …wording for case related data exchange Monitoring compliance in regard to regulatory submissions and/or contractual wording for data exchange Assign tasks ... to MAX Shift/Schedules- Flex, normal dayshift hours Title (Role) Case Management - Manager Organization Global Patient Safety Intake Call Notes with HM: What are the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …adequate systems and process support, including facilitation of respective regulatory inspection preparation, management and follow-up in collaboration with impacted ... flow based on read outs from audits, inspections, Quality Events, regulatory intelligence, effectiveness checks on process implementations and metrics. Support… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …time and within budget to support drug development processes and global submissions . This position also partners with internal and external stakeholders to optimize ... this position possesses a working knowledge of clinical operations and relevant regulatory requirements. This position has experience working on Phase I-IV studies… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Centers of Excellence, Corporate Communications, etc.) Also interacts with Sales, Medical, Regulatory , and Legal. The Manager leads, manages, and directs a ... approval, distribution and lifecycle management of promotional marketing materials. The Manager will oversee the process across designated portions of the portfolio… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Interactions: Leads US FDA/EU EMA interactions with support from higher-level manager . Regulatory Knowledge: Demonstrates expert knowledge of US/EU regulatory ... working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Hinge-Health (San Francisco, CA)
- … approval to introduce new products to market, provide advice on regulatory requirements and prepare regulatory submissions .What You'll AccomplishParticipate ... IDEs, pre- submissions and PMAs.Create and review project deliverables for regulatory submissions .Interact with regulatory agency authorities for initial… more
- Kaiser Permanente (Rockville, MD)
- …HealthChoice, the Program Manager V is a key leader of KP's Regulatory Reporting and Technical alignment with the Maryland HealthChoice program. The Program ... Manager is responsible for regulatory reporting, Medicaid...regulatory reporting, Medicaid IT contractual requirements, and encounter submissions .Job Summary:Manages large-scale programs or components with multiple workstreams… more
- Samsung Research America (Mountain View, CA)
- …research, clinical research and validation, software development, AI / Gen AI, and regulatory submissions . Millions of Samsung users' lives around the world have ... been touched by our products, including the Samsung HeartWise for cardiac rehabilitation and the Samsung ECG Monitor App. Samsung's unique advantage in the consumer electronics market and growing focus on Digital Health and AI / Gen AI provides exciting… more
- Samsung Electronics GmbH (Mountain View, CA)
- …research, clinical research and validation, software development, AI / Gen AI, and regulatory submissions . Millions of Samsung users' lives around the world have ... been touched by our products, including the Samsung HeartWise for cardiac rehabilitation and the Samsung ECG Monitor App. Samsung's unique advantage in the consumer electronics market and growing focus on Digital Health and AI / Gen AI provides exciting… more
- Samsung Research America (Mountain View, CA)
- …research, clinical research and validation, software development, AI / Gen AI, and regulatory submissions . Millions of Samsung users' lives around the world have ... been touched by our products, including the Samsung HeartWise for cardiac rehabilitation and the Samsung ECG Monitor App. Samsung's unique advantage in the consumer electronics market and growing focus on Digital Health and AI / Gen AI provides exciting… more
- Helen of Troy (Boston, MA)
- …our Beauty and Wellness Team at Helen of Troy as our Director of Product Manager , Liquids (hybrid work onsite and from home), and make an immediate impact on our ... formula contains all activities needed to make the claims.Work with legal and regulatory on crafting robust clinical testing plans, driving the completion of all… more
- Takeda Pharmaceutical (Boston, MA)
- …function to ensure compliance to company quality standards and global regulatory requirements. The Principal Archivist contributes to company success by employing ... and retrievability of vital data/records used to support Takeda's global regulatory filings. As the primary archival subject-matter-expert (SME) in Takeda, works… more
- Takeda (Boston, MA)
- …function to ensure compliance to company quality standards and global regulatory requirements. The Principal Archivist contributes to company success by employing ... and retrievability of vital data/records used to support Takeda's global regulatory filings.As the primary archival subject-matter-expert (SME) in Takeda, works… more
- Vertex Pharmaceuticals (Boston, MA)
- …combine attention to detail with a big picture perspective. Experience with regulatory submissions , manufacturing or QC/QA experience a plus. Flex Designation: ... validation, inspection readiness, capacity planning, product launch, lifecycle management and regulatory strategies and commitments. This is an exciting and visible… more
- Vertex Pharmaceuticals Incorporated (Boston, MA)
- …to combine attention to detail with a big picture perspective.Experience with regulatory submissions , manufacturing or QC/QA experience a plus.Flex Designation: ... validation, inspection readiness, capacity planning, product launch, lifecycle management and regulatory strategies and commitments. This is an exciting and visible… more
- Takeda Pharmaceuticals (Boston, MA)
- …experienced, versatile and strong enterprise leadersbe committed to simultaneously driving regulatory approval as well as product launch and global patient ... of the functional sub-teams for a given asset.Accountable with the Global Program Manager for operating budgets within the global program; leads budget setting in… more
