Shuli Cui is a eficient expert, working in Alnylam Pharmaceuticals main office of which is in 518. on the position of Regulatory Affairs Manager since 2018. This person has earned professional experience in more than 12 positions at different companies. Shuli Cui went to the Northeastern University and was studying from 2014 to 2016. This professional has professional qualifications: License 1607085, Protecting Human Research Participants, and Regulatory Affairs Certification (Rac). Boston, Massachusetts is the area, where the professional was lastly known to be settled. The person's e-mail and phone are easily accessed through SoftwareOfficial on demand.
Name variants:
Shuli Cui
Last updated Jun 17, 2024
Contact Information
Last Update
Jul 4, 2022
Email
sc**@alnylam.com, cu**@husky.neu.edu, cu**@hotmail.com
Location
Boston, MA
Company
Workplace
Regulatory Affairs Manager
Cambridge, MA
Industry
Biotechnology, Biopharmaceutical Research, Commercial Physical Research, Biotechnical Research & Pharmaceutical Preparations, Mfg of Pharmaceutical Preparations and Biotechnical Research, Mfg Pharmaceutical Preparations and Biotechnical Research, Pharmaceutical Preparation Mfg
Colleagues
Work History
Regulatory Affairs Manager
675 west Kendall St, Cambridge, MA 02142
from Sep 2018
Regulatory Affairs Manager
85 Wells Ave, Newton, MA 02459
Represented Regulatory Affairs in study teams Supported NDA preparation
Sep 2017 — Sep 2018
Senior Regulatory Affairs Strategy Associate
40 Landsdowne St, Cambridge, MA 02139
Formerly ARIAD Pharmaceuticals Inc.)
Regional Regulatory Lead for Canada
APAC Registration Lead
EU Regulatory Liaison
Regulatory Lead for Clinical Trial Application (CTA)
Supported Glo...
Sep 2016 — Sep 2017
Regulatory Affairs and Clinical Operations Associate
840 Memorial Dr, Cambridge, MA 02139
Prepared IND submissions using eCTD structure and managed regulatory information.
Supported regulatory strategy planning and study design for phase1-3 clinical development.
Oversaw CRO an...
Feb 2015 — Apr 2016
Research Assistent at Antimicrobial Discovery Center
360 Huntington Ave, Boston, MA 02136
Conducted genetic and biochemical experiments on drug-tolerant cells using GLP (Good Laboratory Practice) principles
Assisted microbiology post-doc in a project,
Functional characterizati...
Apr 2014 — Jul 2014
Research Assistant
Boston, MA
Apr 2014 — Jul 2014
Regulatory Affairs Specialist
Cambridge, MA
Provided domestic and international approvals and maintained regulatory compliance
specialized in
510(k), ISO 13485, ISO 9001, and IVD registration
created project plan
Translated China...
2014 — 2015
Internship In Macromolecule Group
700 Pennsylvania Dr, Exton, PA 19341
Engaged in a series of experiments about low molecular weight heparin, including APTT (Activated Partial Thromboplastin Time) determination experiments and the determination of HEPTEST, the...
Sep 2012 — Sep 2012
Genetic Research Assistant
Utilized PubMed, SAS and Meta-analysis to assist research on the association between gene and cancer
Assisted SNP (Single-nucleotide Polymorphism) by analyzing if genes are associated with...
Jun 2011 — Jul 2013
Clinical Research Assistant
Conducted bioequivalent experiments on Paroxetine, Nifedipine, and Clopidogrel using GCP principles ;
Conducted Single-nucleotide Polymorphism (SNP) for RNAi therapy research ;
Prepared c...
Jul 2010 — Jul 2013
Education
2014 — 2016
2013 — 2016
2009 — 2013
Occupations
Executive
Manager
Scientist
Biotechnology Professional
Operations Manager
Biologist
Biological Scientist
Skills
Regulatory Affairs
Fda
Glp
Biotechnology
Quality Assurance
Gmp
Research
Genetics
Medical Devices
Validation
U.s. Food and Drug Administration
Chinese
Regulatory Submissions
Dna Extraction
Pharmaceutical Industry
Clinical Trials
Standard Operating Procedure
Bioequivalent
Sop
Good Clinical Practice
Ind
PROFESSIONAL SKILLS Knowledgeable with technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor
accuracy
and clarity of presentation. Can assist in preparing the Safety Reports (Safety Data and Expedited) for clients and regulatory bodies Can prepare and analyze IND safety reports & Quality Control investigation reports Confident in reviewing product promotional materials
labeling
batch records
specification sheets
or test methods for compliance with applicable regulations and policies. Computer skills include MS-Office
database research.