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...
LI-ZS1, #LI-Hybrid, #PANDO automotive software, manufacturing, audio equipment, audio, full time, direct hire, direct placement, hiring, hybrid, on-site, on site, project planning, issues, tracking, scope, risks, interfaces, dependencies, project status, reporting, lead, led, leadership, leader, PMO...
Currently onsite 2 days a week (Tues+Thurs) remote 3 days.Need a solid Take Charge type PM that can just pick things up and go with it ;A problem solver that can dive in and pull things together....
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...
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...
Global Project Manager will manage large capital projects from project initiation through execution and closeout. The Project Manager will identify and develop the project requirements and then develop the project scope and plan to meet those requirements. Lead cross-functional teams, applying proje...
The ESG Compliance Manager will be responsible for developing, implementing, and executing our company’s ESG strategies and initiatives. The Controllership team in the Finance function plays a critical role in ensuring accurate reporting of the company’s financial information and compliance with rel...
They are looking to add a Regulatory lead to head up the EU side of the Regulatory department. Senior Director of Regulatory Affairs - Responsibilities:. Collaborate with cross-functional teams, including clinical development, medical affairs, and quality assurance, to ensure regulatory compliance a...
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...
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...
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...
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. ...
Project Managers must regularly work with project developers, utilities, equipment manufacturers, engineering firms, investors, bankers, and legal and financial advisors, among others. Project Manager within Leidos' Energy & Infrastructure Consulting Practice. The project Manager will report to ...
Possess the knowledge of support activities that assist the program manager in assessing what programs are within schedule and cost baselines, be able to recommend viable solutions to problems, and the pursuit of alternative courses of action. Applied Research Solutions is seeking a Program Manager ...
Architectural Project Manager - Worcester, MA. Architectural Project Manager (PM) for our Worcester, MA office location. We seek a licensed architect with 10 + years’ experience in the management of architectural projects for educational, commercial and/or institutional projects and who is directly ...
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...
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...
We are looking for an enthusiastic, technically strong Software/Embedded focused Program Manager to join our rapidly growing global team. The successful candidate will enjoy working with high caliber, cross functional teams to deliver high quality software projects and programs. ...
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. ...
Collaborates with other functional work teams , 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 projec...
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...
Provide program level acquisition support to the Program Manager and Integrated Product Team Leads by helping guide successful program execution to maintain the acquisition battle rhythm and deliver warfighter capability. Provide support and solutions to program leadership to facilitate successful c...