Donnelley Financial Solutions (DFIN) is a leader in risk and compliance solutions, providing insightful technology, industry expertise and data insights to clients across the globe.We're here to help you make smarter decisions with insightful technology, industry expertise and data insights at every...
Regulatory Operations Associate. Prepare standard documentation supporting regulatory filings and distribution to stakeholders. Utilize and maintain hard copy and electronic filing systems for auditable regulatory documents. Track regulatory activity, maintain and update databases, and ensure that r...
Moderna Therapeutics is seeking an Associate Director of Regulatory Strategy to support programs within the COVID-19 franchise to be based in one of Modernas US offices. The Associate Director will be a strategic leader within the Global Regulatory Strategy, Infectious Diseases group. As an expert w...
Associate Director Level: Minimum of 7 years in the pharmaceutical industry, with at least 4 years dedicated to regulatory labeling. Develop and implement regulatory labelling strategies for new product labels and launches. Contribute to or lead strategic initiatives, ensuring compliance and alignme...
Collaborate with cross-functional teams to develop and implement regulatory strategies, manage regulatory risks, and ensure compliance with current regulations for cell therapy products. Prepare and manage regulatory submissions (INDs, CTAs, BLAs/MAAs) to agencies like the FDA and EMA. Ensure qualit...
Support the lead regulatory strategy for late-phase oncology programs, ensuring alignment with global regulatory requirements. The client is seeking a seasoned professional to lead their regulatory strategy for a late-phase oncology program. Demonstrate strong regulatory knowledge and expertise, par...
Regulatory Operations Associate. Prepare standard documentation supporting regulatory filings and distribution to stakeholders. Utilize and maintain hard copy and electronic filing systems for auditable regulatory documents. Track regulatory activity, maintain, and update databases, and ensure that ...
We are seeking to hire a junior associate for our nationally recognized Affordable Housing and Community Development practice for our Washington, D. We provide regulatory advice, help our clients complete their transactions, advise on corporate governance and board issues, and supply a full compleme...
I am seeking an experienced associate-level attorney to join a great firm with a federal grants practice group, as well as to support the litigation team. ...
I am seeking an experienced associate-level attorney to join a great firm with a federal grants practice group, as well as to support the litigation team. ...
Data Compliance and Monitoring Specialist. Data Compliance and Monitoring Specialist. The incumbent is responsible for monitoring and reviewing financial transactions/data on an enterprise-wide basis to prevent and detect errors and fraud and to ensure compliance with laws, regulations, policies, an...
Work closely with other Project Managers, Program Managers and customer directors to ensure projects and deliverables are executed as intended. We need a results-oriented Senior Project Manager to support the Nuclear Command, Control, and Communications (NC3) Enterprise Center's (NEC) Systems Engine...
We are seeking a Quality Assurance Compliance Specialist IV to join our Quality department. The Specialist IV will be primarily responsible for managing product development and testing related activities working closely with Analytical development, Quality Control, QA Ops, QA/QC Technical Support an...
The incumbent will serve as an inter-agency consultant on compliance related matters. This person will review to ensure compliance of Davis Bacon certified payrolls and customer Reasonable Accommodation requests. Will manage and monitor compliance reporting, investigate, follow-up and follow through...
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At Epiq Solutions, the senior project manager owns project launch, planning, control, and delivery against timeline and budget. The senior project manager works across functions and with customers to ensure we delight customers, deliver for the business and improve our internal tools and processes. ...
Regulatory Affairs, Advertising and Promotion required; manager experience preferred. Monitor applicable current and new regulatory requirements within Advertising & Promotional practice area; provide regulatory environment updates to Commercial teams when needed. Advanced degree in pharmacy, re...
The Senior Manager, Public Policy in International Government and Regulatory Affairs (IGRA) is an integral position within a global team of public policy and regulatory affairs experts. Play an active role in supporting the execution of key projects within the International Government & Regulatory A...
As a Senior Manager, you'll work as part of a team of problem solvers, helping to solve complex business issues from strategy to execution. Our Tax Controversy and Regulatory Services team helps our clients navigate the Internal Revenue Service process to facilitate compliance, drive issue resolutio...
The Regulatory Affairs Manager will collaborate closely with the Regulatory Affairs Team Lead and business-lead Vice Presidents to develop regulatory strategies to ensure registrations are obtained and maintained to meet business objectives and timelines. The Global Regulatory Affairs Manager direct...
Senior Regulatory Program Manager (GS 13/14) role. The ideal candidate will have a broad understanding of clinical research, regulatory and policy requirements especially NIH, OHRP, and FDA requirements. ...
Monitor project progress, identify potential roadblocks, and implement proactive solutions to keep projects on track. Proficiency in project management methodologies such as Agile, Scrum, or Waterfall, with a track record of successful project delivery. Lead cross-functional teams to successfully de...
Develop regulatory strategies for new product development and market entry, ensuring compliance with FDA, CE, and other international regulatory requirements. Lead and mentor the Quality and Regulatory Affairs team, fostering a culture of quality and compliance throughout the organization. Oversee i...
As a Senior Manager, you'll work as part of a team of problem solvers, helping to solve complex business issues from strategy to execution. Certifications such as Certified Regulatory Compliance Manager (CRCM) or Certified Public Accountant (CPA). Prepare, review, and submit regulatory reports, incl...
Expand the Project Execution Plan for subsequent phases (Project Initiation, Project Execution, Construction, etc. Working under the supervision of a senior PM or above demonstrates and provides project leadership in their area of responsibility. Identify potential project problems or opportunities,...