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...
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...
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...
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...
Direct activities of assigned Regulatory Affairs team with emphasis on global regulatory strategy and the preparation, review, and submission of documents for FDA, EMA and other regulatory authorities. This role includes overseeing regulatory affairs staff, various outside contractors, supporting pr...
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...
As the Employee Listening Program Manager, a typical day might include the following:. In this role you will be responsible for managing our growing employee listening program, keeping a constant pulse on what our people want, feel, and do and providing actionable insights. Strong technology experie...
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...
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...
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...
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...
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 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...
The Project Manager is an integral part of implementing the companys sustainability strategy by managing data collection and reporting with a focus on greenhouse gas (GHG) emissions, assisting with sustainability regulatory reporting / compliance, assisting with managing internal sustainability comm...
Integrated Marketing Program Manager, AVP. We are seeking a collaborative and dynamic individual to help orchestrate integrated programming and governance to ensure marketing programs deliver on organizational goals. Wealth Management Marketing fuels growth by driving brand awareness, consideration,...
The Senior Project Manager is responsible for overseeing project setup, implementation and execution through completion of commission & qualification. Project Manager, Life Sciences. This role must be experienced in cGMP and cGLP capital projects as the Senior PM will lead all aspects of Life Sc...
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 ...
The Infrastructure Project Manager role involves project management activities with the following primary functions:. Project manage multiple strategic projects concurrently. Experience in a Financial organization as a Project Manager, with direct experience with Traders, Front, Middle, and Back Off...
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 Associate, Regulatory Affairs will work with Regulatory Counsel in regulator and entity relationships, cover important legislative and regulatory hearings and meetings as assigned, and supports the Regulatory Affairs function by serving as an enterprise wide resource on public policy and IDR tre...