SMBC is seeking a self-motivated and diligent professional for the associate position within the Controllers - Regulatory Reporting Analysis Group. Assist in the preparation of the quarterly regulatory reports. Assist in maintaining proper controls and documentation associated with regulatory report...
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...
Are you a passionate IT trailblazer – a growth focused, problem solver who takes full ownership of your work, wants to collaborate & co-create with fellow IT experts, innovate, learn new skills, create new solutions & drive your career to the pinnacle of your potential? If so, you will love working....
Join us to be a part of an ever growing, elite IT team & start building your dream career today!To be a successful Regulatory Affairs Specialist you will embody GBSI's core employee characteristics of being passionate about IT, taking full ownership of your work & having a growth mindset. JD details...
CMC Regulatory Affairs Specialist performs regulatory assessment of changes. Interpreting the current, approved and planned clinical regulatory landscape by contributing to the regulatory submission form process. Reviews regulatory submissions to ensure all aspects of global regulatory and CMC compl...
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...
Regulatory Compliance Specialist (14450840). Senior Regulatory Compliance Specialist. Senior Regulatory Compliance Specialist. Supplier Quality, Regulatory Compliance, DEA, and QMS. ...
Ensure compliance with company Standard Operating Procedures and regulatory agency. Represents Regulatory Affairs on cross-functional project teams. Effectively communicate and work collaboratively with cross-functional teams, including regulatory affairs, clinical operations, and quality assurance ...
Site Start-Up & Regulatory Specialist II. Local Submissions Specialist - Follows the project direction provided by the designated country start-up advisor (CSA) and SSUL. Prepares and submits Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or h...
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...
Join us to be a part of an ever growing, elite IT team & start building your dream career today!To be a successful Regulatory Affairs Specialist you will embody GBSI's core employee characteristics of being passionate about IT, taking full ownership of your work & having a growth mindset. JD details...
Compliance and Regulatory Specialist. Bachelor’s degree with at least 5+ years of experience working in the pharmaceutical industry in Quality/Regulatory Compliance, Quality Assurance, Quality Management Systems or associated pharmaceutical manufacturing related function. Associate degree or High Sc...
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...
Job title: Sr Compliance and Regulatory Specialist. 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 ...
Ensure compliance with company Standard Operating Procedures and regulatory agency regulations/guidance. Represents Regulatory Affairs on cross-functional project teams. Effectively communicate and work collaboratively with cross-functional teams, including regulatory affairs, clinical operations, a...
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...
Determine appropriate regulatory requirements and strategies for new product development projects including both domestic and foreign activities and provide regulatory consultation to other internal and external entities. Develop regulatory strategies for new products with the guidance of Regulatory...
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...
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...
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...
POSITION REQUIREMENTS: Education & Experience: • A bachelor’s degree with at least 5+ years of experience working in the pharmaceutical industry in Quality/Regulatory Compliance, Quality Assurance, Quality Management Systems or associated pharmaceutical manufacturing related function...
Performs quality control, research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring that Good Clinical Practices (GCP) are adhered to and communicating protocol deviations appropriately per Standard Operating Procedures...
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...
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. ...