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...
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...
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...
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...
Under the general direction of the Director or designee, the Project Manager III bleads organization-wide large projects. The Project Manager III is responsible for initiating action on multiple projects in a matrix environment. Communicate project status, budget, costs, issues, and related informat...
New York Life Insurance Company is currently seeking managers to become part of our Fast Track Partner program. ...
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...
Reporting to the Director of Facility Operations and Real Estate, assisting in building design features, managing projects, updating drawings of existing buildings and proposed projects. ...
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...
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...
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...
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...
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...
The Assistant Project Manager assists the Project Manager on day to day activities. These activities will include RFIs, submittals, Procore Management, Cost Management, Project Execution, Procurement, Estimating, Project Controls, and Scheduling. Manages project budget and project forecast. Manages ...
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...
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...
The Compliance Assistant Manager is responsible for assisting with the management of DCU's Compliance department, and with the development and management of DCU's Compliance Program and Compliance Management System. Facilitates cooperation and teamwork between team members, Senior Compliance Officer...
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...
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. ...
In addition, this position will support the regulatory department by maintaining data within regulatory data systems, supporting regulatory projects and initiatives and by supporting ongoing regulatory operations. The Specialist, I - Regulatory Affairs will support the maintenance of EU MDR technica...
Splunk is looking for a motivated Senior Analyst who is passionate about delivering technology assurance, advisory, compliance and risk management services to the company. You will ensure proper identification and mitigation of risks / processes / internal control gaps that have potential operationa...
Ensure compliance with quality standards and regulatory requirements for products subcontracted to external entities, adhering to cGMPs and quality directives. Identify and address quality-related issues affecting compliance, regulatory filings, or other risks to company products. ...
In addition the role will also require engagement with other Program and Project Managers in developing best practice systems and processes for project and program execution. Accountable for creation of program plans, budgets and risk registers as well as identifying program and project intercedence...
Education:High School Diploma/GED or equivalent work experience; Bachelor's Degree preferredRequired Skills : PowerBI,Program Management,TableauAdditional Skills : Program Manager,Big Data. Job Summary:The Program Manager, People Analytics will focus on managing human capital projects which wil...