Kelly Patrick, RAC
Sr. Manager Regulatory Affairs at PureTech Health- Claim this Profile
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Bio
Anees Marie Gharzita, RAC
Kelly and I worked for the same parent company and studied for the RAC US exam together. She is a fast learner, a clear communicator of complex concepts, and was a pleasure to work with. I learned a great deal from her in a short period of time. Kelly’s leadership and experience make her an asset to any RA team.
Hsiao-Ling Hung, PhD, RAC
I worked with Kelly on a partnered project dealing with international registrations. Kelly strikes a fine balance of being both personable and professional. She has a well-rounded experience in all facets of regulatory affairs and understands the nuance of complicated international registration strategies. She was very accomodating when we had to conference with our colleagues in different time zones. It is not always easy to communicate with local affiliates but Kelly is culturally sensitive and tenacious in getting things done. I believe her skills and work ethics will bring much value to any global organization.
Anees Marie Gharzita, RAC
Kelly and I worked for the same parent company and studied for the RAC US exam together. She is a fast learner, a clear communicator of complex concepts, and was a pleasure to work with. I learned a great deal from her in a short period of time. Kelly’s leadership and experience make her an asset to any RA team.
Hsiao-Ling Hung, PhD, RAC
I worked with Kelly on a partnered project dealing with international registrations. Kelly strikes a fine balance of being both personable and professional. She has a well-rounded experience in all facets of regulatory affairs and understands the nuance of complicated international registration strategies. She was very accomodating when we had to conference with our colleagues in different time zones. It is not always easy to communicate with local affiliates but Kelly is culturally sensitive and tenacious in getting things done. I believe her skills and work ethics will bring much value to any global organization.
Anees Marie Gharzita, RAC
Kelly and I worked for the same parent company and studied for the RAC US exam together. She is a fast learner, a clear communicator of complex concepts, and was a pleasure to work with. I learned a great deal from her in a short period of time. Kelly’s leadership and experience make her an asset to any RA team.
Hsiao-Ling Hung, PhD, RAC
I worked with Kelly on a partnered project dealing with international registrations. Kelly strikes a fine balance of being both personable and professional. She has a well-rounded experience in all facets of regulatory affairs and understands the nuance of complicated international registration strategies. She was very accomodating when we had to conference with our colleagues in different time zones. It is not always easy to communicate with local affiliates but Kelly is culturally sensitive and tenacious in getting things done. I believe her skills and work ethics will bring much value to any global organization.
Anees Marie Gharzita, RAC
Kelly and I worked for the same parent company and studied for the RAC US exam together. She is a fast learner, a clear communicator of complex concepts, and was a pleasure to work with. I learned a great deal from her in a short period of time. Kelly’s leadership and experience make her an asset to any RA team.
Hsiao-Ling Hung, PhD, RAC
I worked with Kelly on a partnered project dealing with international registrations. Kelly strikes a fine balance of being both personable and professional. She has a well-rounded experience in all facets of regulatory affairs and understands the nuance of complicated international registration strategies. She was very accomodating when we had to conference with our colleagues in different time zones. It is not always easy to communicate with local affiliates but Kelly is culturally sensitive and tenacious in getting things done. I believe her skills and work ethics will bring much value to any global organization.
Credentials
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Regulatory Affairs Certificate (RAC), US
Regulatory Affairs Professionals Society (RAPS)Jun, 2015- Sep, 2024 -
Regulatory Affairs Certificate (RAC), General Scope
Regulatory Affairs Professionals Society (RAPS)Jun, 2013- Sep, 2024
Experience
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PureTech Health
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United States
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Biotechnology
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1 - 100 Employee
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Sr. Manager Regulatory Affairs
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Aug 2022 - Present
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Lonza
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Switzerland
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Pharmaceutical Manufacturing
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700 & Above Employee
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Regulatory Affairs Project Manager
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Sep 2019 - Aug 2022
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Catalent Pharma Solutions
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Senior Regulatory Affairs Specialist
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Oct 2017 - Aug 2019
Biologic and small molecule CMC CDMO regulatory affairs supporting multiple client projects ranging from clinical to post market commercialization in the US and EU markets, currently expanding globally. Biologic and small molecule CMC CDMO regulatory affairs supporting multiple client projects ranging from clinical to post market commercialization in the US and EU markets, currently expanding globally.
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Cook Pharmica
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United States
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Biotechnology Research
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1 - 100 Employee
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Regulatory Affairs Specialist
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Oct 2014 - Nov 2017
Biologic and small molecule CMC CDMO regulatory affairs supporting multiple client projects ranging from clinical to post market commercialization with a current focus on the US and EU markets. Biologic and small molecule CMC CDMO regulatory affairs supporting multiple client projects ranging from clinical to post market commercialization with a current focus on the US and EU markets.
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GOJO Industries, Inc
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United States
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Senior Regulatory Affairs Specialist
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Dec 2010 - Oct 2014
International regulatory affairs with a concentration in Australia, Japan, China and Central and South East Asia over-the-counter (OTC) drug, hygiene, quasi-drug, and cosmetic registrations. Label, copy review of all product related literature/documentation; global regulatory assessment for new and reformulated products. Develop and lead international regulatory processes and strategies for new products as well as manufacturing change control. TGA OTC registrations in Australia… Show more International regulatory affairs with a concentration in Australia, Japan, China and Central and South East Asia over-the-counter (OTC) drug, hygiene, quasi-drug, and cosmetic registrations. Label, copy review of all product related literature/documentation; global regulatory assessment for new and reformulated products. Develop and lead international regulatory processes and strategies for new products as well as manufacturing change control. TGA OTC registrations in Australia. Implementation of NeeS CTD at GOJO. Show less International regulatory affairs with a concentration in Australia, Japan, China and Central and South East Asia over-the-counter (OTC) drug, hygiene, quasi-drug, and cosmetic registrations. Label, copy review of all product related literature/documentation; global regulatory assessment for new and reformulated products. Develop and lead international regulatory processes and strategies for new products as well as manufacturing change control. TGA OTC registrations in Australia… Show more International regulatory affairs with a concentration in Australia, Japan, China and Central and South East Asia over-the-counter (OTC) drug, hygiene, quasi-drug, and cosmetic registrations. Label, copy review of all product related literature/documentation; global regulatory assessment for new and reformulated products. Develop and lead international regulatory processes and strategies for new products as well as manufacturing change control. TGA OTC registrations in Australia. Implementation of NeeS CTD at GOJO. Show less
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International Interfaith Initiative
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Education Management
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1 - 100 Employee
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Development Coordinator
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May 2010 - Dec 2010
Successful grant writing, event organizing, interfaith cooperation. III is part of the Center for Interfaith Cooperation coordinating public awareness events such as thought leader symposium and art exhibits in a shared cooperative office suite with several groups including BRIDGE, Muslim Alliance of Indiana, OBAT Helpers, Cold Spring Institute, Provocate.org. Successful grant writing, event organizing, interfaith cooperation. III is part of the Center for Interfaith Cooperation coordinating public awareness events such as thought leader symposium and art exhibits in a shared cooperative office suite with several groups including BRIDGE, Muslim Alliance of Indiana, OBAT Helpers, Cold Spring Institute, Provocate.org.
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Intercontinental Regulatory Affairs Consultant
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Nov 2006 - Mar 2010
- Review clinical and non-clinical submission documents for meeting international markets' regulatory requirements - Provide global international regulatory strategy to cross-functional Project Teams - Support International Regulatory activities: new product submissions, new indication, device, label changes, lifecycle management - Garner regulatory intelligence for international markets and provide strategy input to global product and project teams - Monitor Biosimilar activities… Show more - Review clinical and non-clinical submission documents for meeting international markets' regulatory requirements - Provide global international regulatory strategy to cross-functional Project Teams - Support International Regulatory activities: new product submissions, new indication, device, label changes, lifecycle management - Garner regulatory intelligence for international markets and provide strategy input to global product and project teams - Monitor Biosimilar activities world wide for two biological parenteral products supported
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Discovery Research Associate Sr Biologist
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Nov 1993 - Nov 2006
- Delivered process improvement initiatives including robot based assays, in-house software development methodology, experimental protocol streamlining; HT (high throughput) assays - Active involvement in the successfully customized and implemented a new imaging software development methodology - Developed and implemented cell-based and enzyme based assays - Multiple extensive cmpd library analyses, decreased turn around time 75% without reducing efficiency - Data crucial to… Show more - Delivered process improvement initiatives including robot based assays, in-house software development methodology, experimental protocol streamlining; HT (high throughput) assays - Active involvement in the successfully customized and implemented a new imaging software development methodology - Developed and implemented cell-based and enzyme based assays - Multiple extensive cmpd library analyses, decreased turn around time 75% without reducing efficiency - Data crucial to determination of yes/no decisions for promising target compounds - Candidate selection, award recipient - Biomarkers (disease and target related) - Designed a murine sepsis protocol allowing study of cardiovascular molecules - Collaborated in development of rodent model of mechanically induced stroke: cerebral protection and recuperation models; development of rodent model recuperation behavioral studies
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Indianapolis Art Center
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Museums, Historical Sites, and Zoos
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1 - 100 Employee
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Fiberart Faculty
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2004 - 2008
- Taught beginning weaving and small loom maintenance - Taught fiber dying and painting (surface design) courses - Taught beginning weaving and small loom maintenance - Taught fiber dying and painting (surface design) courses
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Education
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University of North Texas
BSc, Mjr- Biology; Mnr- Biochem -
2010 - 2011
Indiana University-Purdue University at Indianapolis
in progress, Public Administration- Non Profit Management -
Richardson High School
Spanish and French
Community
