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Randy Carmichael Promoted to the Position of Manager, Regulatory Operations

RESEARCH TRIANGLE PARK, NC: 19 May 2021 – In March 2021, Randolph (Randy) Carmichael, was promoted to the position of Manager, Regulatory Operations at Impact Pharmaceutical Services, Inc. (IMPACT).

As part of the ongoing expansion of the Regulatory Services Department at IMPACT, Randy Carmichael has taken on responsibility for leading the Regulatory Operations (electronic publishing) team at IMPACT. In Randy’s new role as Manager, he will draw from his 30 years of expertise to mentor our publishers, as well as manage the day-to-day operations of our publishing group.

Since joining IMPACT in 2018, Randy has been an invaluable member of the Regulatory Operations team, contributing to many of our most critical and challenging regulatory filings in the US and around the world. “It has been an incredible honor to work with Randy over his tenure at IMPACT thus far,” comments Director of Regulatory Services, Jeff Golden. “Randy’s attention to detail and commitment to meeting client timelines has set the bar for regulatory publishing at IMPACT. In addition to his outstanding technical skills, Randy brings a fun, positive attitude that is well appreciated by his colleagues across the company and by our clients.”

Randy came to IMPACT with over 25 years of regulatory operations experience. He began his career in the former Burroughs Wellcome Company (BW). Shortly after the merger of BW and Glaxo (GlaxoWellcome), Randy joined the newly formed Regulatory Operations group as a submissions publisher. In this capacity, he prepared numerous paper-based INDs, sNDAs and NDAs and, later, submissions as eCTD hybrid applications. Following the merger of GW and SmithKline Beecham (GlaxoSmithKline), Randy worked as a Principal Submission Specialist focusing on US FDA-based submissions. In this position he managed, built, compiled, published, validated, and dispatched major and lifecycle applications for submission in the eCTD format.

Mark Cierpial, CEO and Acting Vice President of Regulatory Services, comments, “I’m so excited to be expanding our Regulatory Services management team at IMPACT, and Randy is the perfect regulatory professional to lead our publishing team. Randy has been a key contributor to IMPACT’s ability to provide top notch regulatory operations services to our clients and, in his new role, will contribute significantly to the continued growth and success of our organization.”

IMPACT is a Contract Research Organization (CRO) located in Research Triangle Park, NC. Our team consists of drug development professionals who specialize in medical writing and quality control, drug development consulting, regulatory affairs, regulatory operations, and project and program management.

Media Contact:

Mark A. Cierpial, PhD, Chief Executive Officer
Phone: (919) 899-9248
Fax: (919) 354-6090
mcierpial@impactpharma.com
www.impactpharma.com

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