Support the development of regulatory strategy and update strategy based upon regulatory changes. Manage the regulatory activities for multiple projects simultaneously and respond readily to changing events and priorities. Ensure timely completion, accuracy, and quality of all regulatory and submiss...
The Director Regulatory Affairs, Strategic Labeling is responsible for setting strategy and leading cross-functional, multidisciplinary, therapeutic teams, and executing multidivisional initiatives for labeling activities for drugs, devices and combination products in assigned therapeutic area(s). E...
Senior Director, Global Regulatory Affairs Strategy. Of each program this position supports, the individual will be responsible for developing and executing the overall regulatory strategy, which includes developing the registration pathway, interacting with regulatory agencies, and being responsibl...
Associate Director, Regulatory Affairs UK. A new opportunity has arisen in the UK Regulatory Affairs Department, at the Associate Director level. Working with Global Regulatory Policy and other stakeholders to advocate for therapeutic areas/local positions on regulatory issues and shape the regulato...
Support the Regulatory Affairs Therapeutic Area Head for IN&F in this strategic leadership position responsible for leading and developing the global regulatory strategies, overseeing health authority interactions and for providing oversight for the preparation, review and evaluation of submissi...
Director Global Regulatory Affairs – Companion Diagnostics/In Vitro Diagnostics. Our Diagnostics focused Regulatory Affairs team helps bring new precision medicine advancements to the world by facilitating effective, efficient, and compliant drug/diagnostic regulatory strategies and approaches acros...
The Senior Director, Regulatory Affairs will lead and formulate the regulatory affairs strategy for pharmaceutical products. Perform regulatory risk assessment and provide regulatory input to the CEO and executive team; provide regulatory strategy for new pharmaceutical developments. Research and ke...
The Director, Regulatory Affairs (Early Development) provides strategic global regulatory guidance to cross-functional project teams responsible for product development. In this role, the Director defines and implements regulatory strategies; works with cross-functional project teams to execute the ...
As the Director, Regulatory Affairs - Advertising, Promotion and Regulatory Compliance, you will be responsible for leading a group of US Regulatory Affairs professionals responsible for advertising and promotion, compliance, labeling and submission operations within US RA. The Director will also se...
Edenbridge Pharmaceuticals is seeking a Senior Manager/Associate Director of Regulatory Affairs to join the Company at its Parsippany, NJ corporate office. Lead and manage a team of Regulatory Affairs professionals. Actively monitor changes in applicable regulatory requirements and industry trends, ...
May represent the regulatory affairs function on Global Project Teams and be responsible for developing and implementing regulatory strategy (US and/or global) to achieve regulatory approvals and competitive product labels. Develop and direct implementation of global regulatory strategy for assigned...
This role will provide CMC regulatory support and guidance for assigned projects and interfaces with R&D, Project Management, Manufacturing, Quality, and Regulatory colleagues to ensure a robust CMC regulatory strategy is developed and implemented to have on time submissions with the highest qua...
Executive Director Regulatory Affairs - Companion Diagnostics & Precision Medicine. Significant experience in regulatory affairs and diagnostic-related development (e. Experience communicating the regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership...
The Associate Director Regulatory Affairs is an integral part of our Regulatory Affairs team based out of our US - Teaneck, NJ site. The Associate Director/Director plays a key role in developing and executing regulatory strategies and ensuring compliance with regulatory requirements that govern the...
The Senior Director, Regulatory Affairs will lead and formulate the regulatory affairs strategy for pharmaceutical products. Perform regulatory risk assessment and provide regulatory input to the CEO and executive team; Provide regulatory strategy for new pharmaceutical developments;. Research and k...
You will work closely with the Inflammation Fibrosis Regulatory Affairs (RA) Franchise Lead, Regional Regulatory Liaisons and cross-functional stakeholders to communicate a clear vision and provide strategic, actionable regulatory guidance that successfully enables regulatory approvals across target...
The Associate Director/Director plays a key role in developing and executing regulatory strategies and ensuring compliance with regulatory requirements that govern the development, registration and commercialization of livestock and poultry products (primarily medicated feed additives and water-solu...
Regulatory Affairs Labeling is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams. Regulatory Affairs Labeling works closely with cross-functional partners to ensure timely and appropriate delivery of product ...
As the Director, Regulatory Affairs - Advertising, Promotion and Regulatory Compliance, you will be responsible for leading a group of US Regulatory Affairs professionals responsible for advertising and promotion, compliance, labeling and submission operations within US RA. The Director will also se...
Regulatory Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams. Significant experience contributing to the development of commercial regulatory or related strategies, ...
As the Director, Regulatory Affairs – Advertising, Promotion and Regulatory Compliance you will be responsible for leading a group of US Regulatory Affairs professionals responsible for advertising and promotion, compliance, labeling and submission operations within US RA. The Director will also ser...
Regulatory Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams. Significant experience contributing to the development of commercial regulatory or related strategies, ...
The Director Regulatory Affairs, Strategic Labeling is responsible for setting strategy and leading cross-functional, multidisciplinary, therapeutic teams, and executing multidivisional initiatives for labeling activities for drugs, devices and combination products in assigned therapeutic area(s). E...
The Director Advertising & Promotion, Regulatory Affairs provides strategic regulatory advice, risk assessment, and mitigation strategies to support the advertising and promotion of assigned products in accordance with business goals and objectives, FDA regulations/guidances, PhRMA guidelines and co...
The Associate Director US Regulatory Affairs CMC is responsible for creation and implementation of CMC regulatory strategies to support the Bayer’s development and marketed product portfolios. Associate Director US Regulatory Affairs CMC. The primary responsibilities of this role, Associate Director...