Regulatory Submissions Jobs in USA

This role is responsible for leading project-specific Chemistry Manufacturing and Control (CMC) matrix teams. The primary responsibility and accountability of the role is to define and deliver contemporary CMC packages during clinical development market authorization and Life Cycle Management (LCM)....

OverviewThe Director of Biostatistics is ahandson statistical leaderresponsible for the design analysis and interpretation ofPhase 1Phase 3 clinical trialswith a primary focus oninflammation and oncology indications. This role combines scientific leadership withactive execution and intensive CRO ove...

Job DescriptionThe Department of Neurological Surgery is a dynamic treatment training and discovery driven enterprise dedicated to improving quality of life through leadership in care and research that restores neural function. Our clinical care research and training mission keeps us at the forefron...

Overview:The Frank H. Netter MD School of Medicine at Quinnipiac University is seeking acollaborative analytical finance leader who thrives in a dynamic academic environment and is committed to the mission values and studentcentered culture of Quinnipiac University as the Director of this role you...

Position Details: Our client a world-leading Pharmaceutical Company in Cambridge MA / Pearl River NY / Collegeville PA is currently looking for a Medical Writer to join their expanding team. Job Title: Medical Writer / ABPI Code (Association of the British Pharmaceutical Industry) Duration: 12 m...

Position Details: Our client a world-leading Pharmaceutical Company in Cambridge MA / Pearl River NY / Collegeville PA is currently looking for a Medical Writer to join their expanding team. Job Title: Medical Writer / ABPI Code (Association of the British Pharmaceutical Industry) Duration: 12 m...

Technical expert that will independently investigate identify develop and optimize new methods/ techniques to address critical project needs. Continuously seek to improve existing laboratory methods and processes. Read and adapt literature to accomplish assignments. Demonstrate mastery of broad rang...

Key Responsibilities:Build and lead key Global Medical Affairs (GMA) capabilities in areas such as medical communications operations field medical and a robust independent scientific research assessment process.Facilitate the development and execution of the multi-year US and global medical strategy...

Responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on market products or those products in development.This individual demonstrates the ability to combine knowledge of scientific regulatory & business issues to enable de...

Purpose:Leads the direction planning execution and interpretation of clinical trials or research activities of one or more clinical development programs with principal responsibility for clinical strategy including the end-to-end Clinical Development Plan(s). Participates in and may lead cross-funct...

Purpose:Leads the direction planning execution and interpretation of clinical trials or research activities of one or more clinical development programs with principal responsibility for clinical strategy including the end-to-end Clinical Development Plan(s). Participates in and may lead cross-funct...

Purpose:Leads the direction planning execution and interpretation of clinical trials or research activities of one or more clinical development programs with principal responsibility for clinical strategy including the end-to-end Clinical Development Plan(s). Participates in and may lead cross-funct...

The Senior Director Regulatory Portfolio Management is accountable for providing program and project management support across the Regulatory Affairs (RA) organization. This includes project management in support of all Global Regulatory Product Teams (GRPTs) as well as the management of the portfol...

The Regulatory Affairs Specialist role is responsible for preparing and submitting the appropriate documentation for FDA 510(k) submissions and documentation for other international regulatory bodies.Responsible for managing and preparing 510(k) submissions to obtain FDA clearance to commercially di...

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are unique...

At RayzeBio every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb RayzeBio blends the nimble pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transfor...

Job Title: Clinical Scientist Medical DevicesLocation: Newark DELong Term ContractRole:Clinical Scientist responsible for developing Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER) to support CE Mark regulatory submissions for medical devices.Key Responsibilities:Develop and a...

Leads the direction planning execution and interpretation of clinical trials or research activities of one or more clinical development programs. Participates in and may lead cross-functional teams to generate deliver and disseminate high-quality clinical data supporting overall product scientific a...

Leads the direction planning execution and interpretation of clinical trials or research activities of one or more clinical development programs. Participates in and may lead cross-functional teams to generate deliver and disseminate high-quality clinical data supporting overall product scientific a...

ResponsibilitiesManages the design and implementation of one or more clinical development programs in support of an overall Product Development Plan based on strong medical and scientific principles knowledge of compliance and regulatory requirements AbbVies customers markets business operations and...