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...
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. ...
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...
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 ...
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...
Eligibilities & qualifications....
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...
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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...
We focus on defining our clients' transformation roadmaps, identifying value opportunities, shaping our clients processes and solutions, and leading large complex business transformation programs enabled by SAP technologies. Set up and lead effective governance and program management office processe...
Global Regulatory Affairs Operation Sr. This position belongs to Global regulatory affairs department, serving the global Market which encompasses China US, EU, AUS and others. This role requires a detail-oriented professional who can oversee all regulatory affairs and quality assurance activities, ...
Responsible for ensuring product compliance standards and industry regulations are adhered to. Work with customers (mainly domestic) and factories/vendors in China to meet compliance and regulatory requirements. Experience with Walmart or Petco nonperishable product compliance. Seeking someone with ...
Bank Compliance Risk Specialist. Bank Compliance Risk Specialist,. ...
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 ...
Regulatory Affairs AD/Director – Labeling. This person will oversee the US Regulatory Labeling activities and processes for regulatory submissions and product maintenance. The RA AD/Director will be responsible for building the team and then leading and managing its growth and development. ...
Product Stewardship Specialist. Product Regulatory expert for Construction Chemical Company responsible for preparing and releasing product safety information for finished and intermediates products across all technologies. Product Stewards work closely with Local and Global Corporate Raw Material, ...
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...
Must be able to create and manage work breakdown structures, project schedules, project budgets, project risk registries, issue logs at an advanced level. Knowledge of generally accepted project management best practices, frameworks, and methodologies across both traditional and Agile approaches is ...
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...
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...
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...
MUST have at least 5 yrs of REGULATORY STRATEGY experience. ...