Scott Smalley

Scott Smalley Email and Phone Number

Regulatory Operations, EDMS & RIM Professional @ IGM Biosciences, Inc.
Scott Smalley's Location
Raleigh-Durham-Chapel Hill Area, United States, United States
Scott Smalley's Contact Details

Scott Smalley personal email

n/a

Scott Smalley phone numbers

About Scott Smalley

With over 24 years of experience in regulatory operations, I am a seasoned professional who can deliver high-quality electronic submissions for the life sciences industry. I have led and supported multiple NDA, BLA, and IND applications, as well as global regulatory submissions, using various electronic document management and publishing systems, such as Veeva RIM, Lorenz Docubridge, and Extedo eCTD Manager.As the founder and consultant of Small-ePublishing, I have helped numerous small to mid-size companies transition to electronic submissions, providing end-to-end solutions from authoring to publishing to submission. I have also served as a subject matter expert for major submission services organizations, sharing my knowledge and best practices on regulatory operations, continuous process improvement, and collaborative problem solving. At Atsena Therapeutics, I was the regulatory operations and RIM director, overseeing the document management and submission preparation for the company's gene therapy pipeline. I am passionate about the production aspect of regulatory operations, and I excel at formatting, harmonizing, and tracking content. I am looking for new opportunities to leverage my skills and expertise in regulatory operations, and to contribute to the advancement of innovative therapies.

Scott Smalley's Current Company Details
IGM Biosciences, Inc.

Igm Biosciences, Inc.

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Regulatory Operations, EDMS & RIM Professional
Scott Smalley Work Experience Details
  • Igm Biosciences, Inc.
    Sr Manager, Regulatory Operations
    Igm Biosciences, Inc. Feb 2023 - Present
    Mountain View, California, Us
    • Provided document and submission level formatting and publishing Support for six active products in multiple countries.• IMPD Conversions• Maintain Regulatory Archives.• Company Point of Contact for Veeva RIM Administration and training.
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  • Small-Epublishing
    Founder, Regulatory Operations Consultant
    Small-Epublishing Mar 2008 - Present
  • Atsena Therapeutics
    Regulatory Operations And Rim Director
    Atsena Therapeutics Sep 2021 - Dec 2023
    View
  • Roivant Sciences
    Global Document Management Director
    Roivant Sciences Oct 2017 - Mar 2022
    New York, New York, Us
    View
  • Dermavant Sciences
    Director, Regulatory Operations
    Dermavant Sciences May 2018 - Jun 2019
    Long Beach, Ca, Us
    View
  • Accenture
    Regulatory Operations Director
    Accenture Sep 2014 - Aug 2016
    Dublin 2, Ie
    Regulatory Operations Subject Matter Expert. Client Presentations. Working with clients bridging requirements between Business Development and Regulatory Operations.
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  • Chimerix, Inc.
    Director Of Regulatory Operations
    Chimerix, Inc. Nov 2013 - Jul 2014
    Durham, Nc, Us
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  • Genitope Corporation
    Reg Ops Manager
    Genitope Corporation 2007 - 2008
    Plan and implement infrastructure to support authoring and submission of BLA's.
  • Pharmacyclics
    Sr. Regulatory Submissions Specialist
    Pharmacyclics 2006 - 2007
    Sunnyvale, Ca, Us
    Ensure an acceptable NDA in the eCTD format.
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  • Neurocrine Biosciences
    Sr. Regulatory Publishing Specialist
    Neurocrine Biosciences 2001 - 2006
    San Diego, California, Us
    Build and manage document management and publishing systems to support multiple NDA's. Build and manage Regulatory Operations department.
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  • Image Solutions, Inc.
    Senior Sales Account Manager/Project Manager
    Image Solutions, Inc. May 2000 - Nov 2001
    Whippany, Nj, Us
    Businesses Development for submission publishing systems and services.
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  • Agouron Pharmaceuticals
    Network Printing Specialist
    Agouron Pharmaceuticals 1997 - 2000
    Ensure successful MAA submission.
  • Xerox Corporation
    Pm Technician/Network Printing Specialist
    Xerox Corporation 1990 - 1997
    Norwalk, Connecticut, Us
    Troubleshooting, Process Improvement of production accounts.
    View

Scott Smalley Skills

Regulatory Submissions Document Management Fda Clinical Trials Documentum Regulatory Affairs Customer Service Drug Development Strategic Planning Management Troubleshooting Microsoft Word Publishing 21 Cfr Part 11 Clinical Development Validation Life Sciences Standard Operating Procedure Electronic Publishing Technical Documentation Continuous Improvement Regulatory Filings Templates Core Dossier Collaborative Problem Solving Formatting Continuous Process Improvement Style Guides Regulatory Guidelines Document Imaging Open Text Livelink Master Control Project Management Submissions Ectd Structure And Granular Placement Advise Formatting Ms Word Files Document Templates Effective Project/team Leader Managing Third Party Vendors Large Scale Systems Implementation Workflow Design And Implementation Ectdxpress Regulatory Operations Electronic Common Technical Document New Drug Application Good Manufacturing Practice Project Management Electronic Management Systems Electronic Submissions Regulatory Documentation Sop Large Scale Systems Biotechnology Biopharmaceuticals Pharmaceutical Industry

Scott Smalley Education Details

  • Grossmont College
    Grossmont College

Frequently Asked Questions about Scott Smalley

What company does Scott Smalley work for?

Scott Smalley works for Igm Biosciences, Inc.

What is Scott Smalley's role at the current company?

Scott Smalley's current role is Regulatory Operations, EDMS & RIM Professional.

What is Scott Smalley's email address?

Scott Smalley's email address is sc****@****ure.com

What is Scott Smalley's direct phone number?

Scott Smalley's direct phone number is +131284*****

What schools did Scott Smalley attend?

Scott Smalley attended Grossmont College.

What are some of Scott Smalley's interests?

Scott Smalley has interest in Social Services, New Technology, Children, Troubleshooting, Problem Solving, Environment, Education, Poverty Alleviation, Disaster And Humanitarian Relief, Human Rights.

What skills is Scott Smalley known for?

Scott Smalley has skills like Regulatory Submissions, Document Management, Fda, Clinical Trials, Documentum, Regulatory Affairs, Customer Service, Drug Development, Strategic Planning, Management, Troubleshooting, Microsoft Word.

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