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...
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...
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...
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 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...
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...
Preferably, sound understanding of financial regulatory agencies and regulatory oversight and supervision. This role will proactively work with varying degrees of the organization to produce and uphold a high standard of risk mitigation including control effectiveness, issue and regulatory change ma...
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...
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 progr...
Assist the Manager of Regulatory Affairs during cGMP, Environmental, and Regulatory audits. Assist the Manager of Regulatory Affairs during periodic quality reviews, regulatory updates, and annual GMP training. Generate Raw Material Regulatory statement: Origin Statement, Cruelty Free statement, Hea...
Regulatory Affairs Specialist (Medical Device). Zing Recruiting, in partnership with an established medical equipment manufacturer stationed in Parsippany, New Jersey is on the search for an experienced Regulatory Affairs Specialist to join their team. Regulatory Affairs Specialist Responsibilities....
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 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...
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...
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 ...
Catalent Pharma Solutions in Somerset, NJ is hiring a Senior Regulatory and Compliance Specialist for the Compliance Group. The Senior Regulatory and Compliance Specialist candidate must be knowledgeable in global regulations pertaining to the pharmaceutical industry and their impact on manufacturin...
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...
Provides guidance/direction within the regulatory department and stakeholder groups relative to regulatory compliance of client's products and processes. Independently support data maintenance and archival and retrieval of regulatory documentation in computerized systems. Assist with preparing high ...
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...
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 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 ...
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 covera...