Michiel Stam

Michiel Stam Email and Phone Number

Management Consultant and Senior Regulatory Expert @ MAIN5
Michiel Stam's Location
Eindhoven, North Brabant, Netherlands, Netherlands
Michiel Stam's Contact Details

Michiel Stam personal email

n/a
About Michiel Stam

I am a Management Consultant and Senior Regulatory Expert at MAIN5 with 15 years of experience in Regulatory Information Management (RIM) and IDMP. In my role I offer strategic direction and subject matter expertise to implement effective Regulatory Information Management (RIM) solutions.Beyond compliance, my focus lies on unlocking the true value of an organization's data through initiatives like XEVMPD, IDMP, and SPOR. By aligning people, cross-functional processes, and tools, I ensure efficient and sustainable data quality.Additionally, I have extensive experience with eCTD and other electronic submission formats. Throughout my career, I have successfully led various submission and regulatory information management projects for Pharma and Biotech companies. This includes the preparation and submission of initial MAA's and post-authorization maintenance for agencies in the EU (CAPs, NAPs and MRP/DCP), US (NDA and BLA), as well as other regions. Feel free to ask any specific questions if you require further details.

Michiel Stam's Current Company Details
MAIN5

Main5

View
Management Consultant and Senior Regulatory Expert
Michiel Stam Work Experience Details
  • Main5
    Management Consultant And Senior Regulatory Expert
    Main5 Jun 2024 - Present
    Frankfurt Am Main, De
    View
  • Qdossier
    Director Regulatory Information Management
    Qdossier Jul 2022 - May 2024
    Waalwijk, Noord Brabant, Nl
    View
  • Qdossier
    Head Of Data Management & Regulatory Information Scientist
    Qdossier Jul 2018 - Jul 2022
    Waalwijk, Noord Brabant, Nl
    View
  • Qdossier
    Regulatory Operations Consultant
    Qdossier Jun 2008 - Jul 2018
    Waalwijk, Noord Brabant, Nl
    View
  • B. Braun Medical
    External Consultant
    B. Braun Medical Mar 2012 - May 2024
    Bethlehem, Pa, Us
    View
  • Dossplorer - Viewing Matters For Ectd, Nees And Other Regulatory Dossier Formats
    Product Manager
    Dossplorer - Viewing Matters For Ectd, Nees And Other Regulatory Dossier Formats Dec 2016 - Jul 2018
    As the product manager of Dossplorer I am responsible for responsible for the strategy, roadmap, and feature definition of the software. This allows me to translate the many years of experience with eCTD and other regulatory dossiers format into an application that adds real value to the business.
  • Astellas Pharma Europe
    External Consultant
    Astellas Pharma Europe 2015 - 2016
  • Takeda Pharmaceuticals
    External Consultant
    Takeda Pharmaceuticals Jul 2014 - Jan 2015
    Tokyo, Jp
    View
  • Genzyme
    Regulatory Operations Consultant (External)
    Genzyme Dec 2013 - Dec 2014
    Paris, France, Fr
    View
  • Genzyme
    Manager Ra Eu Publishing (Ad Interim)
    Genzyme Dec 2012 - Nov 2013
    Paris, France, Fr
    View
  • Glaxosmithkline Biologicals
    External Consultant
    Glaxosmithkline Biologicals Mar 2010 - Dec 2013
    Brentford, Middlesex, Gb
    View
  • Merck Sharp & Dohme
    External Consultant
    Merck Sharp & Dohme Oct 2008 - Mar 2010
    Rahway, New Jersey, Us
    View
  • Crh Fencing & Security Group - Topguard
    Marketing/ Sales
    Crh Fencing & Security Group - Topguard Sep 2005 - May 2008
  • Heras Nederland B.V.
    Marketing Assistant
    Heras Nederland B.V. 2006 - 2006

Michiel Stam Skills

Regulatory Affairs Ectd Pharmaceutical Industry Document Management Regulatory Submissions Pharmacovigilance Regulatory Operations Validation Electronic Submissions Lifesciences Xevmpd Regulations Idmp Computer System Validation Gxp Medical Devices 21 Cfr Part 11 Life Sciences Regulatory Information Management Public Speaking Regulatory Requirements Biotechnology Structured Authoring Master Data Management Reference Data Controlled Vocabularies Change Control Data Migration

Michiel Stam Education Details

  • Uvt Tilburg
    Uvt Tilburg
    General
  • Fontys University Of Applied Sciences
    Fontys University Of Applied Sciences
    Commerciele Economie

Frequently Asked Questions about Michiel Stam

What company does Michiel Stam work for?

Michiel Stam works for Main5

What is Michiel Stam's role at the current company?

Michiel Stam's current role is Management Consultant and Senior Regulatory Expert.

What is Michiel Stam's email address?

Michiel Stam's email address is mi****@****llas.eu

What schools did Michiel Stam attend?

Michiel Stam attended Uvt Tilburg, Fontys University Of Applied Sciences.

What skills is Michiel Stam known for?

Michiel Stam has skills like Regulatory Affairs, Ectd, Pharmaceutical Industry, Document Management, Regulatory Submissions, Pharmacovigilance, Regulatory Operations, Validation, Electronic Submissions, Lifesciences, Xevmpd, Regulations.

Free Chrome Extension

Find emails, phones & company data instantly

Find verified emails from LinkedIn profiles
Get direct phone numbers & mobile contacts
Access company data & employee information
Works directly on LinkedIn - no copy/paste needed
Get Chrome Extension - Free

Aero Online

Your AI prospecting assistant

Download 750 million emails and 100 million phone numbers

Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.