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...
Senior Principal Regulatory Affairs Specialist. Responsible for the overall product strategy, reporting, administrative documentation, due diligence, market expansion, labeling content, regulatory compliance, regulatory intelligence and change management for consumer products (Rx/OTC, OTC Monograph,...
This role will be accountable for leading the development and execution of innovative and value-added global regulatory strategies and be responsible for formulating the Global Regulatory Project Strategy (GRPS) for immunology products in Early Development. At least 8-10 years of relevant pharmaceut...
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...
Regulatory Affairs Specialist Project Lead I (Scientific). This role will be accountable for leading the development and execution of innovative and value-added global regulatory strategies and be responsible for formulating the Global Regulatory Project Strategy (GRPS) for immunology products in Ea...
Regulatory expert support IVDR teams, implements regulatory strategies for IVDR activities; provides regulatory leadership; collaborates with the regulatory staff from other business units, companies, government agencies as needed to develop harmonized policies, procedures and work instructions for ...
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...
Prepare new/revised label packaging for regulatory submissions to the USDA and maintain regulatory documents to ensure site compliance. Support regulatory filing submissions with the USDA for both domestic and international product packaging. ...
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...
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. ...
As a Construction Inspector/ Project Manager on our Civil/Site Work team you will be responsible for providing project support and conducting on-site inspections to ensure compliance with project plans, specifications, and industry standards. We have an immediate opening for a Civil/Site Work Constr...
Regulatory Affairs Manager - Permanent - Bridgewater, NJ. Proclinical is seeking a Manager, Regulatory Affairs for a global medical device company. The Manager, Regulatory Affairs will:. Leads regulatory resources to ensure timely product registrations, regulatory planning for new product introducti...
Project Manager with experience to join our expanding team. Excelling in all phases of construction for sewers, water/wastewater, Pump Stations and site development projects. Water and wastewater design projects experience. Pump station design and rehabilitation, collection system condition assessme...
The Compliance Data Analyst I will report to the GRC Senior Compliance Associate, and assist with ongoing data remediation, data quality checks, license verification from respective state boards to ensure federal, state and EU disclosure reports are reported timely and accurately on behalf of OAPI a...
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...
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 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...
Role has direct and matrixed execution responsibility across all technology organizations as well as LOB Portfolio/Program Manager on the business side for delivering the program/initiatives. Partners with Program Managers, Delivery Leads and SMEs to create business features for technology solutions...
The Project Development Manager. He or she will also participate in all other aspects of the project life cycle including procuring and analyzing due diligence materials during acquisition, contributing input to investment memorandums, and obtaining project approvals/permits. Perform market surveys ...
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...
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,...
MUST have at least 5 yrs of REGULATORY STRATEGY experience. ...
Bank Compliance Risk Specialist. Bank Compliance Risk Specialist,. ...