- Hologic (San Diego, CA)
- … Affairs team here in San Diego, and are looking for a Regulatory Affairs Manager , responsible for on-market regulatory activities associated ... Manager , Regulatory Affairs (IVD)... Manager , Regulatory Affairs (IVD) San Diego, CA,...+ Provide recommendations on labeling, manufacturing, and analytical and clinical study plans for regulatory compliance +… more
- Abbott (Lake Forest, IL)
- …generic medicines. Our 114,000 colleagues serve people in more than 160 countries. Finance Manager - R&D and Regulatory Affairs Finance Full time United ... Abbott Core Diagnostics has an opening for a Finance Manager at our Lake Forest, Illinois location. This individual...budgets for Core Lab R&D organizations, Research, Assay Development, Medical/ Clinical Affairs , Regulatory , new product… more
- AbbVie (Mettawa, IL)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager Regulatory Affairs US Advertising and Promotion ... pharmacology, nursing, pharmacy) plus 7 years of relevant industry experience (eg regulatory affairs fellowship, Health Authority, ad promo, etc.) + Preferred… more
- Sumitomo Pharma (Columbus, OH)
- …seeking a dynamic, highly motivated, and experienced individual for the position of **Senior Manager , Regulatory Affairs ** . The Senior Manager is ... part of the Global Regulatory Affairs (GRA) team based in the US and he/she...+ Leads the preparation, coordination and monitoring of worldwide regulatory submissions related to clinical trials and… more
- Abbott (Santa Clara, CA)
- …imaging catheters and software, vessel closure devices and peripheral stents. This ** Regulatory Affairs Manager ** position is an onsite opportunity ... regulatory changes + Support pre and post approval clinical strategy and submission activities + Anticipate regulatory...Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) + Previous experience… more
- Abbott (Pleasanton, CA)
- …working mothers, female executives, and scientists **The Opportunity** We are seeking a ** Regulatory Affairs Manager ** to join Abbott's Heart Failure ... CA. As an individual contributor, the function of a Regulatory Affairs Manager is to...guidelines, policies and regulations + Ethical guidelines of the regulatory profession, clinical research and regulatory… more
- Takeda Pharmaceuticals (Boston, MA)
- …for the following job opportunity: **JOB LOCATION:** Cambridge, MA **POSITION** : Manager , Global Regulatory Affairs , Marketed Products **POSITION ... : Takeda Development Center Americas, Inc. is seeking a Manager , Global Regulatory Affairs , Marketed...submissions; Provide strategic and tactical guidance to teams, including regulatory review of clinical trial documents and… more
- Bausch Health (Bothell, WA)
- …clearance, Health Canada registration, CE Marking, global product registrations, and clinical evaluations/studies + Regulatory affairs professionals ... marketing strategy for product portfolio which been assigned. + Regulatory affairs professionals actively participate on NPI...one. Please ensure you have discussed with your current manager the intent of applying to a new role.… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Join Gilead and help create possible, together. **Job Description** As an Senior Manager , Global Regulatory Affairs , Precision Medicine, you will help ... schedule in either Parsippany, NJ or Foster City, CA. **Responsibilites:** + Represent Regulatory Affairs Precision Medicine or Dx Regulatory in… 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 ... + Act as the key liaison between the global regulatory affairs team and other departments, such...affairs team and other departments, such as R&D, clinical , quality assurance, manufacturing, and marketing, to ensure that… more
- Teleflex (Atlanta, GA)
- Clinical Affairs Manager , Interventional Urology (SouthEast) **Date:** Apr 12, 2025 **Location:** Atlanta, GA, US **Company:** Teleflex **Expected Travel** : ... accuracy or completeness. 1. Roehrborn, Can J Urol 2017 **Position Summary** The Clinical Affairs Manager partners with the commercial organization to… more
- Houston Methodist (Houston, TX)
- …strategies, monitors legislation and aids in coordinating associations. The Government and Regulatory Affairs Manager position interacts with federal and ... Houston Methodist, the Government and Regulation Affairs Manager position is responsible for regulatory and...that operate at the system level to help enable clinical departments to provide high quality patient care. Houston… more
- BD (Becton, Dickinson and Company) (Sparks, MD)
- …corporate standards/procedures, and regulations + Assist in the development and submission of clinical reports to Regulatory Affairs + Provide guidance to ... will have two direct reports (a director, accountable for clinical study managers, and a manager , accountable... Regulatory Affairs associates on clinical strategy issues + Interface with Corporate Medical … more
- Otsuka America Pharmaceutical Inc. (Columbus, OH)
- …experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, quality ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- Amgen (New Albany, OH)
- The Regulatory Affairs CMC Site Team is responsible for input to the development and implementation of CMC regulatory strategies and activities for products ... Bachelor's degree + 6+ years' experience in manufacturing, testing (QC/QA or clinical ), or distribution in Pharmaceutical/Biotech industry + Regulatory CMC… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …The purpose of this position to act as a team member in the product manager area of Regulatory Affairs (Biopharma) supporting global submissions for various ... Specialist I_** **Primary responsibilities for role:** + Act as Regulatory Affairs representative for specified key products/facilities/equipment. + Prepare… more
- Novo Nordisk (Bloomington, IN)
- …Join Team Novo Nordisk and help us make what matters. The Position The Regulatory Affairs department is accountable for the direct management and guidance ... have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and...regarding the organization's cGMP compliance and regulatory affairs for biologics, sterile injectables, cell… more
- Medtronic (Minneapolis, MN)
- …in a more connected, compassionate world. **A Day in the Life** The ** Regulatory Affairs Specialist** is responsible for developing regulatory strategies, ... submissions and obtaining and maintaining approval for products. Additionally, the Regulatory Affairs Specialist is responsible for assessment of device… more
- Abbott (Alameda, CA)
- …the Diabetes Division. As a manager , the function of an Associate Director Regulatory Affairs , APAC (Asia Pacific) is to combine knowledge of scientific, ... working mothers, female executives, and scientists. **The Opportunity** This **Associate Director Regulatory Affairs - APAC** will work on-site at our Alameda,… more
- Medtronic (Mounds View, MN)
- …with various functions across the business unit, including but not limited to Regulatory Affairs , Research and Development, Clinical , Quality, and Marketing. ... world. **A Day in the Life** The Senior Principal Regulatory Affairs Specialist will play a key...registrations. + Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance. + Monitors… more
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