- 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
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