Associate Director of Regulatory Affairs, Combination Products, will be responsible for providing regulatory guidances to devices / combination product development and life cycle management, including generic products, 505B2 NDA products and biosimilars, preparing and reviewing submissions. Prepare ...
The Associate Director, Regulatory Affairs US Advertising and Promotion is responsible for setting strategy and leading cross-functional, multidisciplinary, therapeutic teams, and executes multidivisional initiatives. Aligns and maintains effective communication channels with key Medical, Marketing,...
The Senior Director/Director of Regulatory Affairs, Biopharma, will provide regulatory guidance for (Bio)Pharma product development and tech transfer, especially biosimilars. The successful candidate will develop regulatory strategies for projects and portfolios in BioPharma, contributing to the tra...
Associate Director of Regulatory Affairs, Combination Products, will be responsible for providing regulatory guidances to devices / combination product development and life cycle management, including generic products, 505B2 NDA products and biosimilars, preparing and reviewing submissions. Prepare ...
Minimum of 10 years in the industry, with at least 8 years dedicated to regulatory affairs. Demonstrated ability to drive high-level regulatory strategy and navigate complex regulatory landscapes. The client is seeking a seasoned professional to lead their regulatory strategy for a late-phase oncolo...
The Director, Regulatory Affairs is responsible for assisting with establishing and managing regulatory strategies, life cycle plans, and pre/post regulatory approvals. Comprehensive knowledge of current US and ex-US regulatory guidelines, in-depth experience leading Regulatory in Global environment...
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...
Hallstar is committed to high standards of quality that ensure our products can be safely produced, handled, and used throughout the global regulatory landscape. We are also committed to providing accurate information for product safety and regulatory purposes, and to the health and safety of our em...
Currently holding a Director Global Regulatory Lead (GRL) position, not seeking those looking to step up from Associate Director. Demonstrated ability to drive high-level regulatory strategy and navigate complex regulatory landscapes. The client is seeking a highly experienced professional to lead t...
The new Global Regulatory Affairs Director is a critical hire to this organization leading PMA regulatory negotiations as the FDA point person as well as guiding clinical affairs, quality management, R&D, and all company team leaders toward successful pre-market approval. In collaboration with the V...
As the Director of Regulatory Affairs, you will be responsible for building and maintaining a global regulatory team, collaborating with quality, sourcing, marketing, R&D, and other functions to ensure our products are of the highest quality and compliant with all regulations. Director of Regulatory...
Coordinates efforts to assure regulatory compliance with standards established by our managed care partners. Develops and leads a regulatory survey readiness program in support of the organization's mission, values and business objectives. Develops and maintains plans to assure compliance with regul...
We are looking for a Director of Regulatory Affairs that will lead our North American region. This senior leader will manage the Americas Regulatory Compliance function and coordinate the regulatory compliance standards and activities for all Colors & Flavors Business Units in Americas. Coach, lead ...
The Associate Director, Regulatory Affairs US Advertising and Promotion is responsible for setting strategy and leading cross-functional, multidisciplinary, therapeutic teams, and executes multidivisional initiatives. Aligns and maintains effective communication channels with key Medical, Marketing,...
The Regulatory Affairs CMC Manager / Sr. Manager is responsible for the on-time filing of high-quality regulatory submissions and for the post-approval maintenance of regulatory dossiers with an emphasis on CMC. Serve as the primary regulatory interface with US FDA manufacturing partners (domestic a...
The Manager position in Regulatory Affairs contributes to the regulatory strategy for new and modified Sysmex medical device products. The Manager Regulatory Affairs is responsible for the preparation, documentation and submission of regulatory applications for Sysmex products. We currently have a g...
Marketing Manager, Projects and Operations. The Marketing Manager will be responsible for marketing project management and strategy. As a member in the marketing department, the Marketing Manager will also work on special projects, as assigned by the Executive Director of Marketing and Vice Presiden...
The Senior Manager Regulatory Affairs is the regulatory expert and is responsible for leading the preparation, documentation and submission of regulatory applications for Sysmex products. The Senior Manager position in Regulatory Affairs leads the regulatory strategy for new and modified Sysmex medi...
What Quality Compliance contributes to Cardinal Health. Quality Compliance is responsible for the development and deployment of policies, procedures and programs designed to minimize risk, enable compliant business operations, products and services and drive uncompromised supply chain integrity. ...
Executive Director of Enterprise Data. National Louis University (NLU) is seeking a dynamic and innovative Executive Director of Enterprise Data to continue the development and implementation of its robust data infrastructure, data management, and data analytics. In this newly created position, repo...
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. ...
The Manager of Regulatory Affairs – Product Development and Post Approval serves as the primary regulatory interface with Partners and internal teams regarding Drug Product and Analytical method development and post-approval activities. Manager, Regulatory Affairs – Product Development a...
Agencies Relationship: Be the point of contact between the company and the regulatory agency – serve as the regulatory liaison. Lead Quality and Regulatory Services Initiatives: Manage aspects of combination product programs and projects, coordinating with both internal teams and external clie...
Regulatory Affairs Professional certification preferred. The Regulatory Affairs Associate is an exempt position that is paid semimonthly. Leads regulatory activities for medical device, over-the-counter, and prescription drug products. Compiles and prepares regulatory documents (summary technical do...