- 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 ... related field and 4 years of prior experience. Prior experience must include: Regulatory submissions to US FDA, EU, and other international health authorities:… more
- Olympus Corporation of the Americas (Westborough, MA)
- …about Life at Olympus (https://www.olympusamerica.com/careers) . **Job Description** Assist the Manager , Regulatory Affairs in obtaining approval to market ... for Canadian Class 2, 3 or 4Device License submissions . Lead development of responses to regulatory ...ability to email, you may call our HR Compliance Manager at 1-888-Olympus (###). **Let's realize your potential, together.**… more
- AbbVie (North Chicago, IL)
- …under limited management supervision. Develops and manages content strategy for regulatory submissions , including INDs/CTAs and amendments, new market ... CMC regulatory product strategies with limited supervision. + Prepares regulatory submissions , including new applications and amendments, renewals, annual… more
- Abbott (St. Paul, MN)
- …Additionally, will coordinate preparation of well organized, complete and scientifically sound regulatory submissions as well as interface directly with various ... vessel closure devices and peripheral stents. **The Opportunity** This ** Regulatory Affairs Project Manager ** position is an...project management skills to plan for, lead and author regulatory submissions in key markets (including US… more
- AbbVie (North Chicago, IL)
- …LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works ... enable first pass approvals. Develops and manages content strategy for regulatory submissions , including INDs/CTAs and amendments, new marketing applications,… more
- Hologic (San Diego, CA)
- Manager , Regulatory Affairs (IVD) San Diego,...of Regulatory Affairs is to submit global regulatory submissions for new commercial products, assess ... here in San Diego, and are looking for a Regulatory Affairs Manager , responsible for on-market ... regulatory strategy and preparing domestic and international regulatory submissions , focused on software and hardware… more
- Abbott (Santa Clara, CA)
- …coordinate global Regulatory Affairs activities including regulatory strategies, submissions and product launches. The Senior Manager is responsible for ... CA currently has an on-site opportunity for a **Senior Regulatory Affairs Manager - Transcatheter Mitral and...appropriately adjust the annual budget for US and EU Regulatory Affairs submissions . + Develops regulatory… more
- Sumitomo Pharma (Frankfort, KY)
- …is responsible for the preparation, coordination and monitoring of routine US regulatory submissions and responses to health authority (HA) information requests. ... motivated, and experienced individual for the position of **Senior Manager , Regulatory Affairs** . The Senior ...Leads the preparation, coordination and monitoring of routine US regulatory submissions (eg, IND/NDA submissions ,… 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 ... post-market surveillance, including annual reports, and other required documents. ** Regulatory Submissions and Documentation** + Manage the...one. Please ensure you have discussed with your current manager the intent of applying to a new role.… more
- Otsuka America Pharmaceutical Inc. (Montgomery, AL)
- …pharmaceutical and/or healthcare industry. - Knowledge and experience with preparation of global regulatory submissions (IND, CTA, NDA or BLA, MAA). - RAC ... planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment with… more
Recent Jobs
-
Fullstack Java Developer
- Insight Global (Charlotte, NC)
-
Product Management Developer
- Fannie Mae (Reston, VA)
-
Java Developer (Backend)
- Two95 International Inc. (Richfield, MN)
-
Senior Manager, IT - Digital Plant Applications & Automation
- Bristol Myers Squibb (Indianapolis, IN)