- Novo Nordisk Inc. (Plainsboro, NJ)
- …of any required documents to FDA.RelationshipsThe fellow will report to the fellowship track manager within the Regulatory Affairs - Therapeutic Area team ... About the Department The Clinical , Medical and Regulatory (CMR) department...Are you ready to make a difference? The PositionThe Regulatory Affairs Therapeutic Area Postdoctoral Fellowship is… more
- Eisai, Inc (Exton, PA)
- …to improve efficiency. Essential Functions 1. Development Projects Assumes CMC regulatory accountability for clinical development documents (INDs, IMPDs, and ... Job Summary Implements global chemistry, manufacturing and control (CMC) regulatory strategies throughout the lifecycle of pharmaceuticals. Coordinates the… 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 ... Medical Affairs interests on cross-functional teams including, Field Medical Affairs , Medical Operations, Clinical Trial Management, HEOR, Market Access,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a regulated GCP environment or equivalent experience preferred- Experience in Clinical Safety and Pharmacovigilance preferred- Medical Affairs experience ... the Oncology Business Unit globally; promote a quality culture within Global Medical Affairs Quality Assurance by providing study team support to uphold the ethical… 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 ... sources, both internally (eg, Global R&D, US Competitive Intelligence, Managed Markets, Clinical Insights, Medical Affairs , Scientific Center of Excellence) and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel required. Position is ... About the Department The Clinical , Medical and Regulatory (CMR) department...Affairs , Medical Strategy & Operations, Medical Information, Publications, Clinical Directors, HEOR Directors, Global Medical Directors, Marketing, and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions ... healthcare providers, key stakeholders and policymakers. Our Market Access and Public Affairs professionals ensure that the latest therapies and products reach the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …market access, commercial effectiveness, sales, medical/CMR, legal, compliance, and regulatory . Other internal relationships include Public Affairs , Government ... have solid understanding of the pharmaceutical marketplace including legal, medical, regulatory and clinical processes Develops accurate short- and long-term… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …key internal relationships may include Medical Affairs , Regulatory Affairs , Marketing, Learning & Development, Clinical Trial Management, and Clinical ... About the Department The Clinical , Medical and Regulatory (CMR) department...Functions Fellow will collaborate with cross-functional areas including Medical Affairs , Regulatory Affairs , Marketing, etc.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... Interactions: Leads US FDA/EU EMA interactions with support from higher-level manager . Regulatory Knowledge: Demonstrates expert knowledge of US/EU regulatory… more
- System One (Deerfield, IL)
- Project Manager (Quality/ Clinical / Regulatory Affairs ) 6 months contract Start: 08/05/2024 to 02/02/2025 Hybrid Northern IL Job Description: The Project ... Manager provides project leadership for high-visibility, highly complex compliance...the globe. This leader works closely with the program manager and project teams to define the business case,… more
- Edwards Lifesciences (Irvine, CA)
- …Mitral and Tricuspid Therapies (TMTT) division. As a Manager in the Clinical , Medical, and Regulatory Affairs Program Management Office, you will ... + Planning: Develop multi-level, detailed project plans to meet clinical , medical and regulatory objectives based on...project plans to meet clinical , medical and regulatory objectives based on cross-functional input and analysis. Build… more
- Kelly Services (Deerfield, IL)
- **Project Manager ** **_(Sterility Quality/ Clinical / Regulatory Affairs )_** + **Location** : (ONSITE) - Deerfield, Illinois (60015) + **Duration** : ... available, now or in the future, for this position. The Project Manager provides project leadership for high-visibility, highly complex compliance initiatives across… more
- Danaher Corporation (West Sacramento, CA)
- …lives with diagnostic tools that address the world's biggest health challenges. The Regulatory Affairs Manager for Beckman Coulter Diagnostics is responsible ... indications within a Therapeutic Area and supports the Sr. Manager Clinical Affairs in the...internal customers who may contribute to regulated communication on Regulatory /FDA issues including Public Affairs , Clinical… more
- Philips (Chicago, IL)
- The Senior Manager Regulatory Affairs will play a critical role within Philips' Clinical Informatics organization by leading regulatory projects for ... world. **Your role:** + Leading project teams for end-to-end regulatory affairs input and deliverables for new... and all key stakeholders including R&D, Marketing, Quality, Clinical Affairs , and other functions at all… more
- Teleflex (Morrisville, NC)
- Sr. Regulatory Affairs Manager - Product Management **Date:** Sep 28, 2024 **Location:** Morrisville, NC, US **Company:** Teleflex **Expected Travel** : Up ... a difference in patients' lives. **Position Summary** The Senior Manager , Regulatory Affairs is an...succession planning, and employee development. 3. Partner with R&D, Clinical , Quality and Design Assurance, Legal, and Marketing teams… more
- Bio-Techne (Minneapolis, MN)
- …Our family of brands creates a unique portfolio of products and services. POSITION SUMMARY The Regulatory Affairs Manager at R&D Systems will lead a team of ... purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides...Regulatory professionals, working closely with the Sr. Director, Regulatory Affairs and the R&D Systems (RDS)… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Sr. Manager , Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory ... following:** + Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of… more
- Philips (Chicago, IL)
- The Senior Regulatory Affairs Program Manager will play a critical role in ensuring Philips' Ambulatory Monitoring & Diagnostics (AM&D) products are ... maintain quality and regulatory compliance. + Reporting to the Head of Regulatory Affairs for AM&D, you will communicate with Internal Stakeholders and… more
- BeiGene (Emeryville, CA)
- **General Description:** + The Senior Manager , Regulatory Affairs CMC, is responsible for developing and implementing global regulatory CMC strategies to ... degree. **Experience:** + Minimum 6+ years of experience in a global CMC regulatory affairs position with expertise in biologics and deep experience in… more
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