Wendy McGhee
(MS, CQA) Regulatory Affairs Manager
- Role
- Health Authority Outreach Manager - Regulatory Affairs at Ispe
- Location
- Dallas, TX, US
- LinkedIn followers
- 500 followers
About Wendy McGhee
With many years of experience in Quality Systems, Medical Devices, and Technical Writing,…
Experience
Health Authority Outreach Manager - Regulatory Affairs
Sep 2022 — Present · Dallas-Fort Worth, TX, US
The International Society for Pharmaceutical Engineering (ISPE) is a not-for-profit association serving its members by leading scientific, technical, and regulatory advancement throughout the entire pharmaceutical lifecycle. ISPE provides a neutral environment where regulators and industry can exchange knowledge to achieve common goals.Drive intelligence gathering on regulators’ areas of interest, looking for synergies with ISPE’s strategic goals. A persuasive communicator and have the composure and credibility to interact with government officials at all levels, exhibiting diplomacy, tact and professionalism. Essential Functions:• Support Sr. Director of Regulatory Operations in implementing ISPE’s Regulatory Engagement Strategy.• Build and maintain a strong network of contacts with key regulators and their support staff in ISPE strategic areas of focus, working with ISPE volunteers and Advisor Consultants as needed.• Work closely with ISPE conference and publications staff, serving as an informed resource for obtaining regulatory speakers and document reviewers.• Identify obstacles to regulators engaging as speakers, document reviewers, or becoming members of ISPE, which may differ from organization to organization, from agency to agency and from country to country. Work with the relevant ISPE staff teams on approaches to mitigate obstacles.• Working with ISPE’s regulatory volunteers, gather intelligence on regulators’ current interests/concerns/priorities using various means, disseminate relevant intelligence to ISPE staff and volunteer teams.• Contribute to the development of ISPE’s Regulator Database by identifying key regulators within global HAs, researching their respective expertise, and entering data as needed.Write, source, and/or review content for ISPE publications
Education
San Diego State University
Master's of Science
Texas Woman's University
Master of Science - MS
San Diego State University
Certification
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