Regulatory Affairs Senior Manager

Responsibilities: Lead the preparation, review, and submission of CMC sections of regulatory filings (e.g., INDs, NDAs, BLAs, MAAs, variations, renewals) to global health authorities, ensuring accuracy, completeness, and compliance with applicable regulations and guidelines. Provide regulatory guidance and support to cross-functional teams throughout...

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, of Marketing Manager, Cardio, Marketing, Manager, Healthcare, Senior, Business Services, Manufacturing

Category Manager/PharmacyTo help achieve these goals Montefiore is recruiting for seasoned Supply Chain leaders to provide expertise, create efficiencies, realize financial savings, and add value for our Clinicians and Associates.The Strategic Sourcing Category Manager/Pharmacy will be responsible for supporting contracting, negotiation, vendor management,...

Category Manager/PharmacyTo help achieve these goals Montefiore is recruiting for seasoned Supply Chain leaders to provide expertise, create efficiencies, realize financial savings, and add value for our Clinicians and Associates.The Strategic Sourcing Category Manager/Pharmacy will be responsible for supporting contracting, negotiation, vendor management,...

Category Manager/PharmacyTo help achieve these goals Montefiore is recruiting for seasoned Supply Chain leaders to provide expertise, create efficiencies, realize financial savings, and add value for our Clinicians and Associates.The Strategic Sourcing Category Manager/Pharmacy will be responsible for supporting contracting, negotiation, vendor management,...

As a Senior IT Applications Analyst (MES) you will be in a business facing role responsible for the configuration, implementation, maintenance, and ongoing support of our MES (Manufacturing Execution Systems) areas. A typical day might include, but is not limited to, the following: Coordinating across business departments and stakeholders, gathering and...

As the academic medical center and University Hospital for Albert Einstein College of Medicine, Montefiore Medical Center is nationally recognized for clinical excellence-breaking new ground in research, training the next generation of healthcare leaders, and delivering science-driven, patient-centered care. Montefiore is ranked among the top hospitals...

Our client, a US company that markets and distributes over-the-counter healthcare and personal care products, is passionate about offering innovative and quality products to customers around the globe. Reporting to the VP of Marketing, the Senior Insights Manager is responsible for ensuring the voice of the consumer and shopper influences all key elements of...

Our client, a US company that markets and distributes over-the-counter healthcare and personal care products, is passionate about offering innovative and quality products to customers around the globe. Reporting to the VP of Marketing, the Senior Insights Manager is responsible for ensuring the voice of the consumer and shopper influences all key elements of...

Job DescriptionJob DescriptionSenior Sales Manager Essential Functions & Responsibilities:Proactive account management with primary focus on the group intermediary segment healthcare, non-profit, Kosher, pharmaceutical, entertainment and legal.Maintains relationship with each accounts’ key group buyers (large and small), end users as appropriate, and other...

Summary: The Quality System Specialist participates in maintaining site compliance of operations inclusive of but not limited to Manufacturing, Quality Systems, Quality Control, Quality Assurance, Facilities Maintenance, Engineering, Materials Handling, and QA Validation in accordance with mandated regulatory requirements and site expectations. The...

Sun River Health is a leading healthcare organization dedicated to providing comprehensive, high-quality medical and social services to underserved communities. We are seeking a highly skilled and experienced Senior Events Manager to join our dynamic team. As the Senior Events Manager, you will play a pivotal role in planning, coordinating, and executing a...

As a Senior Principal Scientist – Imaging Informatics you will support the evolving imaging informatics and analysis needs of Regeneron Clinical Imaging. This will include the generate, ingest, standardize, manage, mine, interpret and visualize clinical imaging data effectively to support data-driven decision-making. The position involves collaboration...

Job DescriptionJob DescriptionDepartment: SourcingJob Overview:The Associate Sourcing Manager's (ASM-strategic sourcing) main objective is to assist in optimizing end-to-end supply chain costs while ensuring best in class supply performance that meets with or exceeds the overall corporate objectives, i.e., cost optimization, inventory reduction,...

Within this role you will be responsible for the development of analytic solutions that support Industrial Operations and Product Supply (IOPS). The analyst will work with the business to deliver analytic solutions that change the way work is currently performed and be able to effectively communicate compelling data stories to leaders across the business....

Job DescriptionJob DescriptionWe are looking for a Senior Corporate Accountant I to join our Accounting team at Aerolase. In this role, you will work cross-functionally across the organization and solve complex problems on a regular basis. If you are looking for an opportunity to make a significant impact on the financial infrastructure of an innovative...

Job DescriptionJob DescriptionWe are looking for a Senior Corporate Accountant I to join our Accounting team at Aerolase. In this role, you will work cross-functionally across the organization and solve complex problems on a regular basis. If you are looking for an opportunity to make a significant impact on the financial infrastructure of an innovative...

Job DescriptionJob Description Software Guidance & Assistance, Inc., (SGA), is searching for an Administrative Coordinator for a CONTRACT assignment with one of our premier Biotechnology clients in Sleepy Hollow, NY (Hybrid).* This will be a 6-month contract opportunity, 2-3 days/week onsite at our Sleepy Hollow, NY locationResponsibilities :Support...

As a Director, Digital Medicine at Regeneron, reporting to the VP, Clinical Sciences, you will play the lead role in driving digital biomarker strategy for clinical development programs. The mission is to transform the landscape of drug trial outcome measures by directly quantifying patient function in a real-world setting. Contribute to the digital...

Within this role you will beresponsible for the implementation and day to day operation of the Regeneron Manufacturing Execution System, the integrity of the data within the system and those provided by the associated data exchanges. You will be responsible for ensuring that MES operations fully meets the needs of the business by aligning with Commercial...