A company is looking for a Senior Regulatory Specialist to support product compliance strategies and ensure regulatory standards are met. ...
Prepares other Scientific and Regulatory documents for submission to Regulatory Authorities including pre-IND Meeting Requests and Packages, Orphan Drug Designation requests, Priority Review requests, Fast Track requests, etc. Experience in preparing regulatory documents, publishing regulatory submi...
A company is looking for an Associate Regulatory Operations Specialist (Remote). ...
Uses general knowledge and familiarity of nuclear safety, security, nonproliferation and regulatory issues in internal meetings, interagency working groups, and interactions with foreign regulatory bodies. The International Relations Specialist will recommend policies and procedures regarding specif...
A company is looking for a Senior Regulatory Compliance Specialist to assist with the implementation and maintenance of its Compliance Software Program. ...
Develops regulatory strategies for moderately to highly complex submissions to FDA and other regulatory agencies. Provides risk assessments of strategies and regulatory options to business teams and to product development/support teams. Represents the business in interactions with regulatory authori...
The Regulatory Affairs Specialist is a critical member of the Regulatory and Laboratory Compliance team of Surgical Critical Care Initiative (SC2i), a precision medicine center located at the Uniformed Services University of the Health Sciences, Bethesda, MD. The Regulatory Compliance Specialist wil...
The Regulatory Affairs Specialist is a critical member of the Regulatory and Laboratory Compliance team of Surgical Critical Care Initiative (SC2i), a precision medicine center located at the Uniformed Services University of the Health Sciences, Bethesda, MD. The Regulatory Compliance Specialist wil...
Ensures that protocol and regulatory documents are maintained and are kept up to date. Maintains study compliance with established local, state, federal, and DoD regulations for human subjects' research with institutional regulatory direction from USUHS, WRNMMC and HJF. Maintains complete and accura...
Regulatory Compliance Specialist . Maintains effective relationships with research staff, Principal Investigators, Institutional Review Board (IRB) regulatory personnel, SC2i consortium regulatory counterparts, and other key stakeholders to ensure the continued scientific and operational functioning...
Regulatory Compliance Specialist. Maintains effective relationships with research staff, Principal Investigators, Institutional Review Board (IRB) regulatory personnel, SC2i consortium regulatory counterparts, and other key stakeholders to ensure the continued scientific and operational functioning ...
Nuclear Regulatory Commission Senior Physical Security Specialist Rockville , Maryland Apply Now. Responsibilities As a Senior Physical Security Specialist, you will assists the Chief, Security Management and Operations Branch (SMOB), in development, direction, coordination and administration of the...
You will primarily assist in the preparation of regulatory submissions for AgNovos’ lead product to ensure compliance with regulatory requirements in the EU, US FDA, and regulatory bodies in other countries. Working with both internal teams and external consultants, you will provide overall regulato...
Position Overview We are seeking a Senior Regulatory Affairs Specialist to lead the development of Standard Operating Procedures (SOPs) and Working Practice Guidelines (WPGs) for managing Data Safety Monitoring Boards (DSMBs) within an electronic DSMB management system. Collaborate with cross-functi...
We are seeking a Senior Regulatory Affairs Specialist to lead the development of Standard Operating Procedures (SOPs) and Working Practice Guidelines (WPGs) for managing Data Safety Monitoring Boards (DSMBs) within an electronic DSMB management system. Collaborate with cross-functional teams, includ...
The Compliance Analyst role within the Housing Opportunities Commission of Montgomery County entails a comprehensive set of responsibilities critical to maintaining and enhancing the quality and compliance of our affordable housing operations. The Compliance Analyst is responsible for identifying an...
A company is looking for a Go-To-Market Program Manager to join their Revenue Operations team. ...
Key Responsibilities:Develop and implement regulatory strategies for global medical device clearances and approvalsManage regulatory submissions and communications with FDA and EU notified bodiesProvide regulatory guidance to cross-functional teams throughout the product lifecycleRequired Qualificat...
A company is looking for a QA (Quality Assurance) Specialist to help ensure the quality of its products and services. Key Responsibilities:Test and review products for quality and functionalityReport bugs and issues to the teamsEnsure products meet company standards before releaseRequirements:Basic ...
A company is looking for an Affordable Housing Compliance Specialist to join their property management team. ...
A company is looking for a Senior Associate, Regulatory Operations. ...
Manager, Regulatory Affairs III to provide strategic direction and operational support for CMC regulatory activities. ...
A company is looking for a Project Compliance Specialist. ...
A company is looking for a Compliance Analyst II to handle compliance-related duties and manage risk within the organization. ...
A company is looking for a Senior Governance, Risk, and Compliance (GRC) Analyst to join their Security & Compliance team. ...