- Fresenius Medical Center (Tampa, FL)
- …AND SCOPE:** Assists in the support of the daily operational activities within Regulatory Affairs for the preparation of regulatory submissions required to ... AND RESPONSIBILITIES:** + A seasoned, experienced professional with a full understanding of Regulatory Affairs; resolves a wide range of issues in creative ways. +… more
- Fresenius Medical Center (Waltham, MA)
- …oral and written communication skills; and be computer proficient. + Experience in regulatory publishing templates highly desirable. + Strong oral and written ... **PURPOSE AND SCOPE:** Ensure overall (other than auditing responsibilities) regulatory compliance for FMCNA pharmaceutical product. Provides regulatory input to… more
- Eurofins (Indianapolis, IN)
- …develop complex regulatory strategies. + Partners with Client RDE ( regulatory associates/ publishing group) to ensure completion of submission activities. ... you're interested in taking your career into a non-lab, regulatory affairs space, this is a great opportunity for...for a career pivot! + Leads preparation, technical, and regulatory review and finalization of CMC sections for global… more
- Eurofins (Indianapolis, IN)
- …develop complex regulatory strategies. + Partners with Client RDE ( regulatory associates/ publishing group) to ensure completion of submission activities. ... of our client's clinical trial portfolio by helping to develop successful regulatory strategies and submissions in support of clinical trials. This position utilizes… more
- Takeda Pharmaceuticals (Boston, MA)
- …members like Clinical Science, Safety, DSRE, DMPK, Clinical and nonclinical Pharmacology, Regulatory Operations, Publishing , and external teams as needed to ... opportunity: **JOB LOCATION:** Cambridge, MA **POSITION** : Manager, Global Regulatory Affairs, Marketed Products **POSITION DESCRIPTION** : Takeda Development… more
- Fujifilm (College Station, TX)
- … Regulatory Affairs Supervisor is responsible for supporting the electronic publishing of regulatory submissions for national and regional regulatory ... at prescribed intervals. **_Required Skills & Abilities:_** + Working knowledge of Regulatory Information Systems, planning and /or publishing tools. + Working… more
- Kelly Services (Bridgewater, NJ)
- …for interactions with Regulatory Authorities. + Deliver final documents to regulatory operations for e- publishing and submission in eCTD format. + ... ** Regulatory Affairs Generalist** Kelly Science and Clinical is seeking a ** Regulatory Affairs Generalist** **for** our client a leading medical device company… more
- AbbVie (South San Francisco, CA)
- …Programming must effectively interface with Statistics, Data Sciences, Medical Writing, Regulatory Publishing and Clinical Operations. Responsibilities + Leads ... sets for individual studies and integrated data. + Creates documentation for regulatory filings including reviewers guides and data definition documents. + Leads the… more
- AbbVie (Worcester, MA)
- …role must effectively interface with Statistics, Data Sciences, Medical Writing, Regulatory Publishing and Development Operations. Responsibilities + Manages a ... sets for individual studies and integrated data. + Creates documentation for regulatory filings including reviewers guides and data definition documents. + Leads the… more
- AbbVie (North Chicago, IL)
- …Senior Statistical Analyst interfaces with Statistics, Data Sciences, Medical Writing, Regulatory Publishing and Clinical Operations. Responsibilities + Leads ... sets for individual studies and integrated data. + Create documentation for regulatory filings including reviewers guides and data definition documents + Leads the… more
- AbbVie (North Chicago, IL)
- …and/or late stage development, interface with Statistics, Data Sciences, Medical Writing, Regulatory Publishing & Clinical Operations. + Develop & oversee ... years utilizing SAS programming concepts & techniques related to drug development & regulatory filings; (ii) 5 years applying CDISC standards, including ADaM & Study… more
- Corning Incorporated (Tewksbury, MA)
- …submission for different regions across the globe. + eCTD technical, formatting and publishing knowledge for regulatory agency submission. + Create or update ... Regulatory Affairs Specialist, Biologics **Date:** May 3, 2025...that improve productivity and enable breakthrough discoveries. **Role Summary** Regulatory Affairs Specialist (biologics focused) provides necessary support to… more
- Astrix Technology (PA)
- …(INDs, NDAs, BLAs, MAAs, etc.) + Ensure submission quality by working with regulatory , clinical, CMC, labeling, and publishing teams + Manage submission data ... ** Regulatory Affairs Specialist (Submissions)** Regulatory Affairs Remote, PA, US Pay Rate Low: 70.00 | Pay Rate High: 75.00 + Added - 06/05/2025 Apply for Job… more
- Google (Los Angeles, CA)
- …into the 21st century, but move information law forward as well. The Music Publishing team is responsible for commercial and product issues related to Publishing ... Rights Management (eg, infrastructure, payments, reporting), collection societies, and regulatory /statutory support. 20th century laws don't always solve 21st… more
- AbbVie (South San Francisco, CA)
- …viral clearance studies + Write technical publications, reports, presentations, and regulatory filings including publishing research in peer-reviewed journals ... and demonstrated success as primary author of publications, presentations, regulatory documents and/or primary inventor of patents + Demonstrated scientific… more
- J&J Family of Companies (Santa Clara, CA)
- …Operations efficiently and effectively. The function of the Senior Regulatory Affairs Specialist, Operations, includes providing submission publishing ... impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory Affairs **Job… more
- AbbVie (San Francisco, CA)
- …areas; interfaces with external groups (eg, Pharmacokinetics, Toxicology, eSubmissions, Regulatory , Statistics, Data Management, Clinical, Publishing ) to ensure ... Description Purpose The medical writer is responsible for providing clinical regulatory document support to clinical teams, ensuring successful preparation of high… more
- Terumo Neuro (Aliso Viejo, CA)
- **12814BR** **Title:** Sr. Specialist, Regulatory Affairs **Job Description:** Responsible for preparing strategy for worldwide product approval submission ... focused on US/EU/Canada and ensuring compliance to FDA and international regulatory agency requirements for Neurovascular and Peripheral devices. Job duties: +… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …to address some of the most challenging global health issues. The Director of Regulatory Affairs reports directly to the Senior Director of Regulatory Affairs. ... with associated Software and Accessories on a global basis from a Regulatory Affairs standpoint. Support will consist of new product development, sustaining, and… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …Become a **maker of possible** with us. **Job Overview** As a Staff Regulatory Affairs Specialist in Advertising/Labeling, you will play a crucial role in supporting ... new product development, sustaining, and end-of-life activities from a Regulatory Affairs perspective. **Responsibilities** * Support regulatory efforts… more
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