Experienced and highly motivated biotech/ pharmaceutical regulatory affairs. Passionate, respected and recognized learner, mentor, and team lead with a proven track record for building strong relationships and the ability to work independently. Committed to the timely delivery of high-quality documentation and submissions. Possesses excellent vproject management, organizational, written, and verbal skills with a keen attention to detail.erbal and written communication, organizational, leadership, and interpersonal skills and project management skills with strong attention to detail.
Open To New Opportunities
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Regulatory Affairs | Project Management | Team LeadOpen To New Opportunities Oct 2023 - Present
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Associate Director, Regulatory Submission ManagementIcon Plc Dec 2020 - Sep 2023Developed and implemented a successful pilot process for the acquisition and on-time delivery of CMC ancillary documentation for regulatory submissions.- pilot process was expanded to encompass client’s in-scope products- on-boarded, trained, and mentored 8 people to provide CAD support resulting in a highly successful and recognized high-performance team.
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Supplemental Contractor At Takeda Pharmaceuticals, Global Regulatory CmcTakeda Pharmaceuticals Aug 2010 - Nov 2020Cambridge, MaResponsible for leading regulatory CMC activities focused primarily on the global expansion and lifecycle maintenance of assigned products.
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Senior Regulatory Specialist | Regulatory Specialist | Regulatory Affairs CoordinatorPfizer (Formerly Wyeth) Nov 2003 - Jun 2010Responsible for providing global regulatory CMC support for investigational and approved products.
Eric Gundersen Education Details
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Gpa 4.00 / 4.00 -
Gpa 3.79 / 4.00 -
Agder Folk School, Norway
Frequently Asked Questions about Eric Gundersen
What company does Eric Gundersen work for?
Eric Gundersen works for Open To New Opportunities
What is Eric Gundersen's role at the current company?
Eric Gundersen's current role is Pharmaceutical Regulatory Affairs | Project Management | Team Leader.
What schools did Eric Gundersen attend?
Eric Gundersen attended Saint Joseph's University, University Of Massachusetts Amherst, Agder Folk School, Norway.
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Eric Gundersen
Denver Metropolitan Area -
4worldandmain.com, blancoamerica.com, arett.com, worldsourcepartners.com
2 +160966XXXXX
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Eric Gundersen
Homestead Disposal, Inc A Local Dumpster Rental Company Serving Home Owners And Contractors In Massachusetts.Westwood, Ma3gmail.com, aol.com, homestead-disposal.com3 +178132XXXXX
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Eric Gundersen
Minneapolis, Mn3mnbankandtrust.com, gmail.com, bridgewaterbankmn.com
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