The individual will be partnering with Regulatory Reporting Analysis team members and business stakeholders to assist with the automation efforts across all regulatory reports. Partner with Regulatory Reporting Analysis team members to understand current reporting procedures and manual processes per...
DSI) is an industry leader in the science of hemostasis and thrombosis.Stago provides the total commitment of global resources and responsiveness, coupled with cutting edge technology and reliability.DSI is dedicated to continually developing and providing the very best h....
The individual will be partnering with Regulatory Reporting Analysis team members and business stakeholders to assist with the automation efforts across all regulatory reports. Partner with Regulatory Reporting Analysis team members to understand current reporting procedures and manual processes per...
The Regulatory Compliance and Product Development Specialist ensures compliance with regulatory standards for packaging, labeling, and nutritional information, supports product development, manages costing and pricing, and collaborates cross-functionally to facilitate smooth product launches. Ensure...
Internal Job Title: Regulatory Affairs Associate II. Canada Chemical regulatory oversight and review. Position requires a Bachelor's degree in a science or chemistry-related field, coursework or certification in Cosmetic or Drug Regulatory Affairs. ...
The individual will be partnering with Regulatory Reporting Analysis team members and business stakeholders to assist with the automation efforts across all regulatory reports. Partner with Regulatory Reporting Analysis team members to understand current reporting procedures and manual processes per...
Lead the activities for preparing an oral solid dose manufacturing site for inspections by US FDA and applicable foreign regulatory authorities. Assist the site in preparing written responses to address the observations for customer audits, internal audits, corporate audits, and regulatory inspectio...
The individual will be partnering with Regulatory Reporting Analysis team members and business stakeholders to assist with the automation efforts across all regulatory reports. Partner with Regulatory Reporting Analysis team members to understand current reporting procedures and manual processes per...
Assist the Manager of Regulatory Affairs during cGMP, Environmental, and Regulatory audits. Responsible for facility registrations, renewals, and document submissions to regulatory agencies (eg Drug and Cosmetic listings, etc), under the direct supervision of the Head of Quality/Regulatory. Assist t...
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...
The International Regulatory Specialist is responsible for collecting, organizing and creating documents required for international regulatory filings and registrations. Then International Regulatory Specialist will work with internal teams, contract manufacturers and 3rd party brands to assemble th...
The individual will be partnering with Regulatory Reporting Analysis team members and business stakeholders to assist with the automation efforts across all regulatory reports. Partner with Regulatory Reporting Analysis team members to understand current reporting procedures and manual processes per...
Perform additional tasks and lead additional work streams, from time to time and upon request, concerning the regulatory regime or corporate governance applicable to the Company’s business. Requires 2 years of providing regulatory guidance (analyzing and interpreting laws and regulations) or complia...
The Senior Regulatory and Compliance Specialist candidate must be knowledgeable in global regulations pertaining to the pharmaceutical industry (or regulated industry equivalent) and their impact on manufacturing processes and practices. This role has high visibility within the Somerset site and the...
The Senior Specialist is responsible for developing CMC regulatory submission strategies and timelines for assigned pharmaceutical projects/products in accordance with global regulations and guidance. The Senior Specialist is also responsible for the preparation and review of information required fo...
Ready to be part of something special?.This position provides technical support and guidance in FDA, USDA and CFIA label compliance regulations.This position works closely with other departments, including Legal, Marketing, Quality Assurance and Operations and will work with outside consultants as n...
The Senior Regulatory and Compliance Specialist candidate must be knowledgeable in global regulations pertaining to the pharmaceutical industry (or regulated industry equivalent) and their impact on manufacturing processes and practices. This role has high visibility within the Somerset site and the...
Reporting to the Regional Vice President of Government Relations, you will have substantial contact with state regulatory officials on the timely approval and implementation of ISO filings, and related issues. Timely approval and implementation of ISO's regulatory filings of insurance program c...
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...
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...
Lead the activities for preparing an oral solid dose manufacturing site for inspections by US FDA and applicable foreign regulatory authorities. Assist the site in preparing written responses to address the observations for customer audits, internal audits, corporate audits, and regulatory inspectio...
Assist the Manager of Regulatory Affairs during cGMP, Environmental, and Regulatory audits. Responsible for facility registrations, renewals, and document submissions to regulatory agencies (eg Drug and Cosmetic listings, etc), under the direct supervision of the Head of Quality/Regulatory. Assist t...
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 ...
We are seeking a dynamic and experienced Innovation Regulatory Specialist interested in further developing and drivingour growth of. Collaborate with cross-functional teams and our plant in Canada to resolve any regulatory compliance issues and provide solutions to meet regulatory requirements. The ...
Autonomously support new product development core teams including development of regulatory strategies and the preparation of regulatory content for domestic and international submissions for IVD medical devices to support the core team's approved scope of regulatory activities, with focus on instru...