- Sanofi Group (Morristown, NJ)
- **Job Title:** Regulatory Submission lead **Location:** Morristown, NJ/ Cambridge MA **About the Job** Are you ready to shape the future of medicine? The ... be critical in helping our teams accelerate progress. The Submission Lead is responsible for the planning,...is responsible for the planning, co-ordination and tracking of regulatory submission activities for assigned programs at… more
- Sanofi Group (Morristown, NJ)
- …and leadership to metadata specifications and project/study specific data requirements + Lead regulatory submission activities, including electronic ... (ie statistical concepts, techniques and clinical trial principles) and ability to lead regulatory submissions + Ability to collaborate with external partners… more
- AbbVie (Florham Park, NJ)
- …multiple disciplines to advance medicines to our patients. Responsibilities: + Provide expertise/ lead regulatory submission and product life-cycle management ... regulatory requirements for work processes are met. Critically review regulatory submission documents. Participate in discussions with regulatory … more
- Mizuho Corporate Bank (New York, NY)
- VP, Liquidity Regulatory Reporting Lead The Liquidity Regulatory Reporting is a team responsible for the daily and monthly reporting and submission of ... US Branches production team, ensuring the accurate and timely submission of reports in compliance with regulatory ...explaining changes in the FR2052a reporting data. Responsibilities: + Lead and manage the Liquidity Regulatory Reporting… more
- Citigroup (New York, NY)
- …The objective of this role is to support the execution of regulatory interactions across Risk Management, to ensure the organization is responsive, agile ... and well-prepared for unique and demanding regulatory requests. The position will require project management and stakeholder engagement to ensure that regulatory … more
- Sanofi Group (Morristown, NJ)
- …of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (GRL), the Regulatory Strategist (RS) leverages their ... as well as for lifecycle management of products. + May serve as a regional/local regulatory lead and point of contact with HAs for projects/products in their… more
- J&J Family of Companies (Raritan, NJ)
- …risk and opportunity playbooks, scenario evaluation and business case development). + Lead operations with Global Regulatory Team (GRT), including activities ... clinical variations and Pediatric submissions, partnering to ensure alignment of Regulatory and compound submission strategies, developing clear and detailed… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- … trends, innovation, and compliance while balancing business benefits and risks. + Lead and Manage Global Regulatory Submission Activities: Oversee ... in the area of Biosimilar/BLA submissions including strategize, compile, review and manage/ lead regulatory submissions. Subject matter expert in the area of… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- … regulatory guidance throughout the product development cycle prior to regulatory submission . + Identify and communicate appropriately quantified risks and ... justifications for changes that do not require a 510(k) submission . + Coordinate and prepare technical files for ...regulatory associates to register our devices worldwide. + Lead regulatory efforts required to follow new… more
- Merck (Rahway, NJ)
- …product life cycle. + Oversee and independently lead the preparation, submission , and follow-up of regulatory applications and ensure quality and compliance ... International Regulatory Affairs with prior experience as a Global Regulatory Lead + Demonstrated scientific knowledge, writing ability, effective… more