- Cardinal Health (Columbus, OH)
- …and risks for products and develops plans for product development programs and regulatory submissions . **_Job Summary_** The Manager , Regulatory ... matter expertise to provide services in technical writing and regulatory submissions as well as clinical research... authorities and provides insights to senior leadership regarding regulatory developments. The Manager leads a team… more
- 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
- 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
- Sumitomo Pharma (Columbus, OH)
- …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
- 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
- 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. (Columbus, OH)
- …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
- Otsuka America Pharmaceutical Inc. (Columbus, OH)
- …leadership and guidance for Process Mapping Teams (eg, Key stakeholder for Regulatory Submissions , Key stakeholder for Clinical Trial Application Regulatory ... The Sr. Manager , CTA Regulatory Strategy is responsible...regulatory strategy, planning, and execution of global investigational submissions and manages lifecycle regulatory activities for… more
- ThermoFisher Scientific (Austin, TX)
- … strategies! + Responsible for providing guidance to ensure that all regulatory submissions are planned, communicated, and performed per regulatory ... Sequencing and/or PCR assays + Facilitate FDA pre-submission meetings + Prepare US regulatory submissions (PMA, PMA supplement, and 510(k)) for Next Generation… more
- Stryker (Mahwah, NJ)
- …authority interactions with internal teams + Ensure quality and compliance of regulatory submissions , labeling, and marketing materials + Communicate and ... We are currently seeking a **Senior Manager , Regulatory Affairs** to join our...of global medical device regulations including direct experience with regulatory submissions associated with US and EU… more
- Abbott (Alameda, CA)
- …as industry trends and trains staff regarding changing regulations that affect regulatory submissions . Maintains knowledge of current and pending regulations ... levels with our new sensing technology. **The Opportunity** This ** Regulatory Affairs Manager - International Compliance Operations**...of those years related to the preparation of FDA submissions (PMA, IDE, 510(k)) for Class I, II, and… more
- RWJBarnabas Health (Somerset, NJ)
- …workflow of the Department through establishing, tracking project milestones and coordinating submissions . Manager assists in obtaining regulatory approval ... Regulatory Planning Manager (Hybrid) - Somerset,...licensure and certificate of need processes. + Coordinates Departmental submissions to Department of Health such as licensure renewals,… more
- AbbVie (Irvine, CA)
- …LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description Description The Sr Manager Regulatory Affairs represents US regulatory affairs for ... and guidance documents, as well as technical reports, in support of regulatory submissions . + Advanced knowledge of US medical device regulations. + Ability to… more
- CareOregon (Portland, OR)
- …or contractors. + Use data analytics to identify and monitor trends in regulatory submissions and pursue initiatives that offer efficiencies, close gaps, and ... Job Title Regulatory Affairs Program Manager Department Legal...deliverables including coaching on how to achieve higher quality submissions . + Develop, implement, and sustain a quality/performance review… more
- Vera Therapeutics (Brisbane, CA)
- …will be responsible for working with the cross-functional team to lead and support regulatory submissions and activities in the US and globally to support ... Title: Senior Manager , Clinical Regulatory Location: Brisbane, California...clinical studies in early-to-late development to create high quality regulatory submissions that support product development strategy… more
- Procter & Gamble (Mason, OH)
- Job Location Mason Job Description We are looking to hire a Regulatory Operations Manager for our Personal Health Care (PHC) team based in North America. This ... grow within a diverse, vibrant, and supportive team environment at P&G As the Regulatory Operations Manager , you will: + Collaborate with cross-functional US PHC… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …The Manager , Regulatory Affairs will: + Prepare, review and approve regulatory submissions (ie ANDAs, amendments, supplements, etc.) to the Food and Drug ... * Manager , Regulatory Affairs Date: Apr 2, 2025...Interact with the FDA to facilitate approval of the regulatory submissions . + Maintain awareness of all … more