- Technical Resources International (Bethesda, MD)
- …technology, and communications services. TRI, Inc. is currently seeking a Regulatory Operations Associate . Responsibilities Prepare standard documentation ... maintain hard copy and electronic filing systems for auditable regulatory documents. Maintain effective high-profile communications and interactions with colleagues,… more
- Kelly Services (Miami, FL)
- …compliance monitoring and execution activities for US, Latin America and Canada operations . The Regulatory Compliance Associate performs entry-level ... and daily export order activity; supports basic operational measurement of regulatory compliance functions; facilitates scheduled reporting on operations ;… more
- MacroGenics, Inc (Rockville, MD)
- …timelines, budgets, clinical sites, vendors and deliverables while maintaining quality and regulatory compliance. The Associate Clinical Operations Director ... communication etc. plans) site selection and budget planning. Directs Clinical Operations team members on daily tasks and activities. Monitoring Activities -… more
- eclaro (Trenton, NJ)
- RIM Database Associate Lawrenceville, NJ Duration: 6 months initial (potential extension or right to hire) Be part of a company that delivers life-changing ... healthcare solutions. Eclaro is looking for a RIM Database Associate for our client in Lawrenceville, NJ. Summary The... will be a subject matter expert in the Regulatory Information Management (RIM) system with a focus on… more
- RRD International, LLC (Arlington, VA)
- …Responsible for the management of regulatory programs and acts as regulatory operations team lead for comprehensive development programs Performs ... and therapeutic areas. We are looking for a full-time Associate Director, Regulatory Affairs based in our...(Chemistry Manufacturing Controls, pre-clinical, or clinical) and serves as regulatory operations team member for ongoing programs… more
- Beacon Hill Staffing Group (Cambridge, MA)
- …background with some clinical development experience (in any function) The Global Regulatory Associate Director is responsible for developing and directing the ... Associate Director, Global Regulatory Affairs (CMC)...a cross-departmental group of regulators as part of Global Regulatory Team, including CMC, Operations , Labeling, International,… more
- Orca Biosystems Inc. (Menlo Park, CA)
- The Sr Regulatory Affairs Associate is a critical hands-on position and is responsible for leading and executing on all regulatory activities within the ... for the coordination, preparation and review of filings and maintenance of regulatory submissions. * Leads hands-on activities and coordination in preparation and… more
- Integrated Resources, Inc ( IRI ) (Lexington, MA)
- Job Title: Associate Director, Global Regulatory Affairs (CMC) Duration: 06 months+ Location: Cambridge, MA Description: Top 3 Must Haves 1. Previous ... with a cross-departmental group of regulators as part of Global Regulatory Team, including CMC, Operations , Labeling, International, Advertising/Promotion and… more
- Orchard Therapeutics (Menlo Park, CA)
- Location: Menlo Park (US) Reporting to: VP Regulatory CMC Orchard Therapeutics Limited is a global biotechnology company dedicated to bringing transformative gene ... founded in November 2015 and is rapidly expanding its operations in the EU, US and in other regions....four years ago, we're an exciting start-up where a Regulatory Affairs professional can have a real impact on… more
- Merck (West Point, PA)
- …Process Development, Technical Services, Utilities and Validation. GENERAL SUMMARY: The Associate Director, Technical Operations is responsible for the oversight ... regulatory authority representatives. Working Relationships: Reports to Technical Operations Director. Manages employees within own department. Interacts with… more
- Amgen (Tampa, FL)
- …P2P Governance and Vendor Master Operations ) are looking for an authoritative AP Regulatory Reporting Senior Associate to join the AP Operations Team. ... Amgen's Global Procure-to-Pay Operations team (Global Procurement Operations , Accounts...through effective, efficient and compliant P2P process. The Senior Associate will report to the Senior Manager Finance and… more
- Atrium Staffing (Edison, NJ)
- … Agency requirements Participate in the development and maintenance of Regulatory Operations systems, processes, checklists and procedures to facilitate ... Our client is a pharmaceutical company, looking to hire a Regulatory Affairs Associate . Salary/Hourly Rate: DOE Position Overview: The Regulatory Affairs … more
- AbbVie (Mettawa, IL)
- The Associate Director, Regulatory Affairs US Advertising and Promotion is responsible for setting strategy and leading cross-functional, multidisciplinary, ... industry knowledge. Key Responsibilities Include: Make decisions and plans for operations (work flow, assignments, staff development) within area of responsibility… more
- Amicus Therapeutics Inc (Cedar County, IA)
- …living with rare metabolic diseases. The Associate Director of Global Regulatory Affairs, Operations will be responsible for managing all publishing ... authorities (e. g. IND, NDA, MAA, etc.). Selects, negotiates, and manages regulatory operations software/service providers and vendors. Leads the development and… more
- AbbVie (Sunnyvale, CA)
- … strategy Oversee development of dossier filing plan and associated timelines with regulatory operations lead Provide oversight to filing and study teams ... General Position Summary/Purpose: The Associate Director/Director of Regulatory Affairs, under the accountability of the Senior Director, Regulatory Affairs,… more
- Technical Resources International (Bethesda, MD)
- …. Responsibilities Manages and/or supervises a Team of Regulatory Managers, Regulatory Specialists, Regulatory Operations Associates, and Human Subjects ... requirements Strong management and leadership skills; experience in leading regulatory operations /submissions teams a plus Direct experience interacting with… more
- Daiichi Sankyo (Bernards, NJ)
- …veteran status, age, or any other characteristic protected by law. Job Title Associate Director, Regulatory Affairs Labeling City Basking Ridge Functional Area ... Summary This position serves as the RA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
- Regeneron Pharmaceuticals, Inc. (Tarrytown, NY)
- …- Working Knowledge of scientific and industry terminology - Experience in Regulatory Affairs/ Operations - Thorough knowledge and practical experience in global ... business systems projects; creating, maintaining, and training on pertinent Regulatory procedural documents; supporting business needs by liaising with internal… more
- Integrated Resources, Inc (Cambridge, MA)
- …with a cross-departmental group of regulators as part of Global Regulatory Team, including CMC, Operations , Labeling, International, Advertising/Promotion and ... Top 3 Must Haves 1. Previous regulatory experience as a Global lead or (less...as prime internal and external contact on contracts or operations . Interacts with equivalent level managers concerning matters of… more
- Amgen (Thousand Oaks, CA)
- …product lead. Train staff on select CMC procedures and systems. Interface with regulatory operations staff. Contribute to CMC product teams: interacts with ... technical teams, including plans for execution of the strategy. The Regulatory Affairs CMC Senior Associate will interface with the Amgen Regulatory Affairs… more
