CMC Regulatory Affairs Specialist performs regulatory assessment of changes. Interpreting the current, approved and planned clinical regulatory landscape by contributing to the regulatory submission form process. Reviews regulatory submissions to ensure all aspects of global regulatory and CMC compl...
A typical day might include the following:Reviews regulatory submissions to ensure all aspects of global regulatory and CMC compliance (beyond GMP compliance) are met and fully support clinical supplyCollaborates cross-functionally to support the submission strategies and impacts on supply and regul...
CMC Regulatory Affairs Specialist performs regulatory assessment of changes. Interpreting the current, approved and planned clinical regulatory landscape by contributing to the regulatory submission form process. Reviews regulatory submissions to ensure all aspects of global regulatory and CMC compl...
As a Regulatory Specialist (also known as Regulatory Affairs Specialist, Compliance Specialist), you'll play a crucial role in ensuring that our cosmetic products comply with all applicable regulations and standards. Your responsibilities will include monitoring and interpreting relevant regulations...
The Clinical Regulatory Compliance Specialist provides and supports regulatory, accreditation and certification activities to achieve and sustain ongoing compliance. Experience working with regulatory and accreditation systems (eg. Identifies and assesses risk as an integral part of the regulatory c...
Responsible for overseeing, generating and reviewing technical documentation supporting pharmaceutical regulatory submissions. Generates and reviews technical documentation supporting regulatory submissions. Evaluates options to address technical challenges within regulatory submissions and presents...
The salary range for this position is noted within this job posting.Where an employee or prospective employee is paid within this range will depend on, among other factors, actual ranges for current/former employees in the subject position; market considerations; budgetary considerations; tenure and...
We are currently looking to fill a Sr CMC Regulatory Sciences Specialist position. Routine activities include overseeing, generating, and reviewing technical documentation supporting pharmaceutical regulatory submissions. Manages and coordinates the authoring, review, and finalization of CMC documen...
Troubleshoot location challenges with compliance program platform, maintaining compliance etc. Under moderate supervision, ensures First Student's driver, monitor, technician, and staff maintain compliance under Federal/State/contractual rules and regulations. Upload and compliance date maintenance ...
Position OverviewAs a Senior Director of Regulatory Affairs, you will manage a team of regulatory professionals who analyze new regulatory requirements, work closely with the business to understand the impact and obligations of those requirements, and support the business in understanding the evolvi...
Position OverviewAs a Senior Director of Regulatory Affairs, you will manage a team of regulatory professionals who analyze new regulatory requirements, work closely with the business to understand the impact and obligations of those requirements, and support the business in understanding the evolvi...
The Associate Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. Utilize regulatory expertise and knowledge...
In addition, Senior Regulatory Affairs Associate is responsible for supporting a variety of activities in the department related to regulatory submissions and R&D requests, and supporting other departments within the organization. Ability to review regulatory and scientific submission documents ...
Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs related to the development of novel therapeutics including quality, preclinical and clinical areas of drug development and the policies/procedures requi...
CMC Regulatory Affairs Specialist performs regulatory assessment of changes. Interpreting the current, approved and planned clinical regulatory landscape by contributing to the regulatory submission form process. Reviews regulatory submissions to ensure all aspects of global regulatory and CMC compl...
This management position in Regulatory Affairs involves the ability to lead and manage a Therapeutic Area (TA) within Regenerons Regulatory Affairs organization so that all corporate objectives are met within specified timelines and so that the necessary state of compliance is maintained relative to...
The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. Utilize regulatory expertise and knowledge of regula...
Perform the compliance activities of the portfolio to determine regulatory impact and associated submission requirement for clinical and commercial regulatory filings in accordance with country specific regulatory guidance documents. Support CMC development activities from a regulatory standpoint du...
Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs related to the development of novel therapeutics including quality, preclinical and clinical areas of drug development and the policies/procedures requi...
Title:: Network Project Manager - IV. Responsible for executing implementation aspect of engineering projects for Inbuilding/ DAS/ oDas and small cell upgrades for 4G LTE and 5G mmW; Including but not limited to installation, commissioning, and integration. Scheduling, forecasting, and tracking for ...
In this role, a typical day might include the following:Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development, including, but not limited to, the following: INDs/CTAs, amendments and info...
The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. Utilize regulatory expertise and knowledge of regula...
Job Description: Anti-Fraud Team is looking for an Analyst and Associate level compliance Business analyst to support a project. The Analyst will be working on a project within the Anit-Fraud team. ...
The Senior Director - Regulatory Affairs is responsible for managing Regulatory Affairs activities (nonclinical and clinical) for assigned investigational and/or marketed products. This individual is expected to be capable of serving as the Regulatory Project Lead for assigned projects, responsible ...
As a Compliance Specialist within Process Sciences, a typical day might include, but is not limited to, the following:. Driving compliance-related process improvements and efficiencies associated with PS laboratory operations is a key task. Supporting PS laboratory personnel on compliance-related to...