- Takeda Pharmaceuticals (Boston, MA)
- … regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with ... 4 years of prior experience. Prior experience must include: Regulatory submissions to US FDA, EU, and...conduct comment resolution meetings for timely resolution of comments; Regulatory Intelligence : Perform regulatory analysis,… more
- Bausch Health (Bothell, WA)
- …all inclusive of the duties and responsibilities for this position title._ The Manager Regulatory Affairs provides direct support to Solta operations for their ... for post-market surveillance, including annual reports, and other required documents. ** Regulatory Submissions and Documentation** + Manage the preparation,… more
- Philips (Bothell, WA)
- …while serving the public access AED, EMS, military, and hospital market segments. In this Regulatory Affairs Program Manager role and as part of an agile company ... workers who depend on these innovative life-saving solutions. The Regulatory Affairs Program Manager will play a... will play a critical role in preparing comprehensive regulatory strategies, submissions and post market changes… more
- J&J Family of Companies (Raritan, NJ)
- …talent for a **Senior Manager , Data Analytics & Insights** to support the Regulatory Affairs Data Office. **Purpose** : This role will lead the development of a ... R&D, and Clinical Affairs, to gather and analyze data relevant to regulatory workflows, including submissions to Health Authorities. + Monitor industry… more
- Amgen (Washington, DC)
- …Join us and transform the lives of patients while transforming your career. **Global Regulatory Policy and Intelligence Manager ** **What you will do** The ... United States Regulatory Lead (USRL), Sr. Manager is assigned to one or more Amgen products,...Lifecycle maintenance) for their country(ies), where applicable. + Ensures regulatory submissions are made on time and… more
- Deloitte (San Diego, CA)
- …Experience introducing new technologies such as GenAI/AI/ML and automation for pharmaceutical regulatory content or regulatory intelligence + Understanding ... with regulatory digital transformations / innovations + Experience with submissions management, labeling, CMC change control and/or LCM processes + Knowledge… more
- AbbVie (Pleasanton, CA)
- …* Ensures that teams and functional groups are provided with clear, constructive regulatory advice and intelligence to assist planning and issue resolution ... YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description 1. Submissions , development and lifecycle maintenance * Plans and prepares complex … more
- Olympus Corporation of the Americas (Center Valley, PA)
- …to internal and external stakeholders; support Publication strategies. + Support Regulatory submissions . + Facilitate communication between Sales and Marketing, ... closeout of evidence generation activities to support product development, regulatory approval, reimbursement strategies, and overall commercialization of Olympus'… more
- Olympus Corporation of the Americas (Center Valley, PA)
- … Regulatory Affairs team(s) to align the IT architecture to facilitate regulatory submissions , document management, and compliance tracking and to ensure ... . **Job Description** The Lead Enterprise Architect (Product Development & Regulatory Compliance) is responsible for developing a forward-looking technology strategy… more
- Olympus Corporation of the Americas (Westborough, MA)
- …new product developments. + Support with the interpretation and impact of regulatory intelligence coming from regions within responsibility. + Support ... with regional counterparts to coordinate, develop, submit and maintain registration submissions and to provide international regulatory support throughout the… more