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...
What you’ll do: Help animals in need! Our highly skilled technicians play a crucial role in our program, working as a team with CM veterinarians and assistants to provide essential services to the pets and rescue animals that need us most. What you’ll get: Work/life balance:paid vacation time to rel...
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 for ...
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 for ...
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...
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...
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...
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...
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...
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...
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...
Assistant Survey Project Manager. Candidates can expect to work on a wide variety of survey projects in different sectors such as commercial, transportation, environmental, industrial, institutional, and energy projects. Be a part of a growing group of survey professionals working on a wide variety ...
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 ...
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...
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...
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 Quality Compliance Specialist ensures quality and compliance tocGMPs, internal, external, and international requirements with respect to change control activities. We are currently looking to fill a Principal Quality Compliance Specialist position on the Quality Assurance Change Control Team. As...
The Senior Project Manager in Process Sciences manages timelines, leads projects, monitors department operations, develops a company-wide and external network and leverages relationships to enable department objectives. Leading cross functional teams and managing the deliverables for the assigned pr...
Squarespace is looking for a Payroll Specialist to join the Payroll function of our growing company. You will report to the Head of Global Payroll & Compliance. ...
Fortress Investment Group seeks an entry level Compliance Analyst to join the Fortress Compliance Department. The successful candidate will work with members of the Legal and Compliance Department and other departments and businesses around the firm on, among other things, the following major items:...
Provides training, education and coaching to providers and staff regarding accurate and complete medical record documentation and coding in compliance with established documentation and coding standards. Audits medical records to assure compliance with applicable coding and documentation standards. ...