Update and develop procedures for the regulatory affairs in supporting changes in the regulatory landscape, including EU MDR. Assist the strategy implementation and operations for regulatory affairs activities, including directing development of product registration submission, progress reports, sup...
The Regulatory Affairs Lead will be responsible for ensuring compliance with all regulatory standards and guidelines, leading the preparation and submission of regulatory documents, and overseeing the development of generics including Risk Evaluation and Mitigation Strategies (REMS) programs. Our cl...
Role: Senior Regulatory Affairs Specialist. Update and develop procedures for the regulatory affairs in supporting changes in the regulatory landscape, including EU MDR. Assist the strategy implementation and operations for regulatory affairs activities, including directing development of product re...
They engage in correspondence, meetings, and interactions with the FDA to address regulatory inquiries, respond to requests for additional information, and seek clarification on regulatory matters under the guidance of the Director, US Market Access. Analyzes and communicate the adequacy of proposed...
Eligibilities & qualifications....
We currently have an opening for a Regulatory Affairs Specialist II. This position is responsible for Regulatory Affairs support of submissions and on-going regulatory compliance for product development process. Acts as a core team member on development teams, providing Regulatory Affairs feedback a...
Hiring - Senior Regulatory Affairs Specialist. Assess applicable change requests for regulatory impact and follow-up on related regulatory action items. Support marketing, R&D and Lonza BU in ad hoc projects, in relation to market growth and innovation initiatives by preparing US regulatory assessme...
Prepare new and maintain existing regulatory files in accordance with regional requirements, including but not limited to document updates, management of regulatory information in databases, and navigating document control systems. Review regulatory content for completeness, accuracy, consistency, a...
As a Quality & Regulatory Affairs Specialist (m/w/d), you will be in charge of providing support to Capital Equipment servicing as well as to EMEA Quality and Regulatory Organisation to ensure quality and regulatory compliance. ...
The Project Manager (PM) leads the project team and works in partnership with our Field Management to build and deliver a safe, high quality, profitable project. The Project Manager will oversee and manage all phases of project delivery including scope execution, schedule, and budget for environment...
Program/Business Development Manager - US Army. Provides Contractor Program Management support for a US Army program developing next-generation weapons technology. Demonstrates commitment to the EEO Program by assuring compliance with all program goals/objectives and Management Control Process respo...
Animal Care/Use Compliance Specialist. Animal Care/Use Compliance Specialist. Additionally, this role may lead less experienced specialists and provide regulatory guidance to investigators. Maintains all related records in compliance with HMH SOPs and regulatory requirements. ...
We are seeking a Senior Financial Analyst, Sarbanes-Oxley (SOX) Compliance and Controls to join our team within the controllership function of Broadridge Financial Solutions, reporting to the Senior Director, SOX Compliance and Controls. Assist in the preparation of reports and presentations for man...
Bank Compliance Risk Specialist. Bank Compliance Risk Specialist,. ...
MUST have at least 5 yrs of REGULATORY STRATEGY experience. ...
Support the development of regulatory strategy and update strategy based upon regulatory changes. Manage the regulatory activities for multiple projects simultaneously and respond readily to changing events and priorities. Ensure timely completion, accuracy, and quality of all regulatory and submiss...
With over 10 years of construction project backlog, this firm is well-positioned to grow and provide lifetime careers for its people. Trust me, I have placed multiple people there who have told me so! This organization is looking to hire a Construction Code Specialist to provide management, oversigh...
Are you interested in improving and shaping the delivery of IT projects industry? We’re seeking a Desktop Engineering Project Manager to oversee a Windows 11 upgrade project. The ideal candidate is required to have excellent project management skills, with experience in organizing, planning, and exe...
As a Payroll Tax Analyst, you will act as the subject matter expert and support HR Operations with day-to-day inquiries to complex payroll issues and tax questions. Research state and local jurisdictions for tax compliance. Support Multi-State tracking and compliance. Experience with federal, state,...
Under the general guidance of the Director Regulatory Affairs, Regulatory Affairs Associate plays a crucial role in ensuring the quality, and accuracy of drug product submissions to regulatory authorities. Some of the key functions include ensures the smooth compliant flow of information between all...
Corporate - Legal and Compliance. Lead special assignments and perform targeted investigations on potential financial crime concerns to support the Compliance function. Contribute to financial crimes compliance policies, procedures, processes, and training. Track compliance issues to completion and ...
The Senior Associate, Regulatory Affairs is responsible for supporting applications under pre and post approval conditions. Under the direction of Regulatory Affairs management, participate in drug development from early stage development through final formulation, ensuring compliance with principle...
Associate Program Manager - Existing Homes/Home Performance. Associate Program Manager - Existing Homes/Home Performance. Utility Programs and Services (UPS) division to lead and grow ICF's energy efficiency programs. You will lead the development and management of energy efficiency programs, build ...
The Regulatory Affairs Manager will be responsible for independently compiling and maintaining compliant US drug product applications throughout product lifecycle i. The Regulatory Affairs Manager is a self-motivated, detail-oriented, flexible team player who is able to multi-task, and work independ...
The Associate Director, Regulatory Affairs - Regulatory Project Management (RPM) provides planning and drives coordination of global and US regulatory activities. The Associate Director RPM is responsible for supporting the global regulatory lead (GRL), US regulatory lead (USRL) and global regulator...