Chad Vickery Email and Phone Number
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Chad Vickery personal email
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As an experienced RA professional, I possess the fundamental knowledge and skills to engage others, drive results and effect positive change in the regulatory and quality compliance status of a company. I am skilled at providing interpretation of regulatory guidance(s), regulations or directives and advising senior management on the applicability or impact on internal programs or products. I am proficient at offering regulatory strategy, support and quality guidance to cross-functional teams throughout product development, submission approval and life-cycle management for various product types. An accomplished educator, I am adept at training and managing junior staff. Twenty-plus years of career experience in a variety of professional capacities has provided me the superior verbal and written communication skills necessary to effectively interface with clients, colleagues or senior management and achieve positive results.
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Director, Regulatory AffairsAfaxys, Inc.Charleston, Sc, Us
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Associate Director Of Regulatory AffairsAfaxys, Inc. Feb 2022 - PresentCharleston, Sc, Us
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Regulatory Affairs ManagerPharmaceutical Associates Inc., (Pai) Mar 2018 - Feb 2022Greenville, South Carolina, UsResponsible for managing the CMC team at PAI, providing guidance and direction for regulatory filings with the US FDA for the largest Unit Dose liquid drug product manufacturer in the US. Support the Regulatory Affairs department in assessing proposed process changes for regulatory impact. Provide guidance to various project teams to support drug development and commercial manufacturing for more than 50 commercial prescription and over-the-counter products. Support labeling, drug safety, compliance and staff development activities as needed. -
Regulatory Affairs ManagerParagon Bioservices, Inc. Sep 2017 - Mar 2018Responsible for supporting clients US and EU regulatory submission strategies. Participate in multidisciplinary project teams with the client providing guidance and direction on current regulatory pathways and expectations. Write and review regulatory submission documents with a critical eye for suitability to FDA and any other regulatory agencies requirements. Remain current on changes to the regulatory environment that could impact the company's contract manufacturing strategies. Monitor applications under review, manage and track submission and maintenance processes to support regulatory applications. Work with quality and document control groups to ensure proper assessment of documents and regulatory document archiving.
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Regulatory Affairs ManagerPatheon Mar 2011 - Sep 2017Waltham, Massachusetts, UsCompetently managed a CMC submission under the pressure of a shortened submission time-line and was subsequently promoted to RA manager. Written numerous CMC submissions in eCTD format filed with FDA, EMA and Health Canada. Develop and encourage cross-functional relationships, both internally and externally, to foster understanding of global regulatory strategy and provide innovative solutions to enhance the probability of regulatory success and compliance. Successfully managed FDA cGMP compliance and pre-approval inspections. Navigate and support client submissions to FDA, EMA, Health Canada, UK-MHRA, TGA (Australia) and Japanese Ministry of Health. Develop training documents and standard operating procedures to support the regulatory and quality assurance process. Evaluate proposed changes to commercial manufacturing operations for regulatory impact and filing requirements. Mentor, educate and train other regulatory and quality staff to enhance regulatory knowledge. Provide guidance and review support for analytical and process validation projects. Author and review technical reports including: annual product reviews, analytical and process validation documents, equipment qualifications, deviations and change controls. -
TeacherAnderson School District One Aug 2000 - May 2009Williamston, Sc, UsWrote the district-wide science curriculum and coached a winning Science Olympiad team. Developed the leadership and management skills necessary to effectively lead others. Created and implemented daily learning opportunities for a diverse student population. Effectively lead a number of staff development opportunities for colleagues. -
ChemistPharmaceutical Associates Inc Jun 1998 - Jul 2000Greenville, South Carolina, UsSuccessfully worked part-time while in graduate school and finished at the top of my class. Developed a proficiency in various analytical techniques including: HPLC, GC, IR, extractions, distillations and wet-chemistry techniques. Maintained detailed records.
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ChemistRogers & Callcott Environmental Jun 1993 - Jun 1998Greenville, Sc, UsEstablished myself as an analytical chemist and was promoted to trace-metals department. Learned various techniques including: AA, extractions, distillations and wet-chemistry techniques.
Chad Vickery Skills
Chad Vickery Education Details
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Wofford CollegeGeneral -
Converse UniversitySecondary Education And Teaching
Frequently Asked Questions about Chad Vickery
What company does Chad Vickery work for?
Chad Vickery works for Afaxys, Inc.
What is Chad Vickery's role at the current company?
Chad Vickery's current role is Director, Regulatory Affairs.
What is Chad Vickery's email address?
Chad Vickery's email address is cv****@****rma.com
What is Chad Vickery's direct phone number?
Chad Vickery's direct phone number is +186493*****
What schools did Chad Vickery attend?
Chad Vickery attended Wofford College, Converse University.
What skills is Chad Vickery known for?
Chad Vickery has skills like Regulatory Affairs, Regulatory Submissions, Pharmaceutical Industry, Quality Assurance, Quality Control, Regulatory Compliance, Ctd Module 3, Ectd, Fda Gmp, Cgmp Manufacturing, Technology Transfer, Drug Substance Manufacture.
Who are Chad Vickery's colleagues?
Chad Vickery's colleagues are Robin Flannery, Pmp, Kelsey Kob, Arden Dodge, Olivia Leland, Melissa Mccann, Natalie Salvatore, Nikki Black.
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