Provides leadership to the Regulatory labeling team in the creation and maintenance of global product labeling components. Supply Chain, Operations, Commercial and Clinical, providing regulatory guidance to aid in the preparation and submission of global product labeling materials. Employs a current...
Experienced with the preparation and submission of regulatory documents, including PIND meeting packages, INDs, NDAs, ANDAs, regulatory correspondence, and amendments. Well established European pharmaceutical firm that supports the pharmaceutical industry with Intermediates, API's, Drug Products and...
Provides leadership to the Regulatory labeling team in the creation and maintenance of global product labeling components. Collaborates with other functional work teams , Supply Chain, Operations, Commercial and Clinical, providing regulatory guidance to aid in the preparation and submission of glob...
This includes developing and implementing regulatory strategies for product approvals, leading the registration of products, ensuring compliance with global regulatory requirements, and managing the regulatory affairs team. Title: Regulatory Affairs Manager. The Regulatory Affairs Manager will be re...
The Ethics & Compliance Manager Position reports directly to the Ethics and Compliance Director, who reports to the VP of Enterprise Risk Management & Compliance (including Data Privacy and Protection). This individual will support the development, implementation, and maintenance of the Oper...
As part of a team-based approach to care, the Clinical Care Manager (CCM) provides, coordinates, and organizes evidence-based care management to Medical Assistant Treatment Program (MAT) patients. We are currently hiring a Clinical Care Manager – OBAT RN based in Framingham. Responsible for as...
Senior Director of Regulatory Affairs - Responsibilities:. Senior Director of Regulatory Affairs - Requirements:. They are looking to add a Regulatory lead to head up the EU side of the Regulatory department. Collaborate with cross-functional teams, including clinical development, medical affairs, a...
Regulatory Affairs Certification (RAC) or equivalent preferred. Ensure that all products and processes comply with applicable regulatory requirements (e. Prepare and submit regulatory documentation and applications, including product registrations, certifications, and renewals. ...
Preclinical, Clinical, Medical Affairs, Manufacturing and Quality Control, providing regulatory guidance to aid in preparing, reviewing, and approving of regulatory NDA/IND/CTA/IMPD submissions materials. Manages a range of concurrent regulatory projects, and issues, and responds timely to ensure re...
The Social Compliance Manager will be responsible for communicating program requirements and expectations to TJX Associates, buying agents and vendors. Manages Social Compliance Senior and Social Compliance Specialist. At TJX, our philosophy towards social compliance mirrors our culture, and just as...
We are looking for a commercial roofing project manager/estimator to be responsible for planning projects and preparing budgets and timelines. Commercial Roofing Project Manager/Estimator. Commercial Roofing Project Manager/Estimator Qualifications and Responsibilities:. Commercial Roofing Project M...
Kirby Bates Associates, a national healthcare leadership firm, has an engagement opportunity for an Interim Manager/ Documentation Regulatory Specialist in Massachusetts at a residential and LTC facility. The leader must be able assist at the unit levels with hands-on monitoring and mentoring and ha...
They are seeking a dynamic Director of Regulatory Strategy to steer our groundbreaking projects through the complex regulatory landscape with vision and precision. Director, Regulatory Strategy. Bachelor's degree in a relevant life sciences field with at least 8 years of experience in the biopharmac...
Who you are - Commercial Compliance Analyst. Represent the Compliance Team, as needed, by actively participating in Institutional Projects and communicating follow up items, compliance considerations, and areas of concern back to the team. As a member of our Compliance Department, you will join a dy...
As a Trade Compliance Analyst, you will play a key role in ensuring our company's compliance with global customs authorities and facilitating day-to-day trade compliance activities. Are you an enthusiastic professional looking to expand your experience or start a career in Trade and Compliance? Rand...
Supports global regulatory strategy and execution on development programs, including maintaining strong relationships with cross-functional internal colleagues, regulatory agencies, CROs, consulting groups, and other third parties. Significant regulatory affairs experience is required. Provides stra...
Manages NAFTA/USMCA compliance program to ensure compliance. Maintains company-wide Export Management System, ensuring compliance with. Updates import-export compliance manuals - standard operating procedures regulations. Performs audits to evaluate compliance levels and effectiveness of procedures,...
The Business Program Manager manages key client programs and projects. Overseeing a portfolio of complex projects and programs concurrently for key customer accounts. This may involve multiple Project Managers, cross-functional teams, and several enterprise projects. Cultivating and sustain robust w...
The position will be responsible for reviewing and authoring all Customer Quality external audit responses prior to submission to corporate compliance and / or regulators. The position will ensure adequate tracking and monitoring of all external and internal Customer Quality commitments to facilitat...
Lead the Global Design Quality Assurance, Regulatory & Clinical Affairs functions for Waters Clinical Business Unit, with emphasis on global strategy for in vitro diagnostic clinical business activities. Leads Quality, Regulatory and Clinical Affairs functions:. Manage and conduct Regulatory Affairs...
Our client is currently seeking a Senior Regulatory Compliance Specialist. Monitor international standards and guide regulatory testing requirements. Assist with risk analysis and regulatory submissions. ...
Regulatory Affairs (RA) Specialist?. Regulatory Affairs (RA) Specialist who wants to grow your skills and take the lead on U. You will report to the SVP, Global QA, RA & ESG and work closely with colleagues from R&D, Product Management & Marketing, QA&RA and other functions, to plan ...
Regulatory Compliance & Quality Systems Specialist / Sr. Specialist – looking for - staff in this area, also with + years of experience supporting oper ations regulatory inspections, audits, and working within the. Familiar with US FDA CFRs, regulatory guidance, and cGMPs; prior experience in an aud...
This newly created role will partner with Risk Management, Legal, Information Technology, third-party providers, and myriad TJX businesses globally to help oversee solution development and data assurance assignment for risk and compliance purposes. As we continue to grow, external and internal facto...
As an Internal Controls Advisory & Compliance Manager, you will manage compliance testing, risk and control assessments and documentation for the TJX Sarbanes-Oxley (SOX) Office, and other compliance programs, as needed. Internal Controls Advisory & Compliance Manager. You will collaborate with memb...