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Andre Pearson Email & Phone Number
Principal Medical Regulatory Writer and CMC Scientist Senior Manger
at
University of Pennsylvania (Gill Laboratory)
1 work email found
@upenn.edu
10 phones found area 781, 617, 718, 607, 860, and 206
LinkedIn matched
✓ Verified May 2026
4 data sources
Profile completeness 100%
Current company
Role
Principal Medical Regulatory Writer and CMC Scientist Senior Manger
Location
New York City Metropolitan Area, United States, United States
Who is Andre Pearson? Overview
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Quick answer
Andre Pearson is listed as Principal Medical Regulatory Writer and CMC Scientist Senior Manger at University of Pennsylvania (Gill Laboratory), based in New York City Metropolitan Area, United States, United States. AeroLeads shows a work email signal at upenn.edu, phone signal with area code 781, 617, 718, 607, 860, 206, and a matched LinkedIn profile for Andre Pearson.
Andre Pearson previously worked as Principal Medical Regulatory Writer & CMC Scientist Senior Manger at University Of Pennsylvania (Gill Laboratory) and Project Manager at Celgene. Andre Pearson holds Master Of Science (Msc), Chemistry from Wesleyan University.
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Email format at University of Pennsylvania (Gill Laboratory)
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{first_initial}{last}@upenn.edu
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Profile bio
About Andre Pearson
SUMMARY OF QUALIFICATIONS- Developed CMC product strategies and lifecycle management- Served as a resource to other departments inside and outside of R&D on regulatory-related product development issues- Led interactions and negotiates with global regulatory authorities regarding programs and initiatives that significantly impact the business - Authored: 2.3 Quality overall summary, 3.2.S Drug substance, 3.2.P Drug product- Reviewed/edited Technology transfer reports, analytical development and testing reports, formulation development reports, process performance qualification reports, pharmaceutical development report- Led submissions for author for INDs, BLAs, NDAs, CTAs, IMPDs, MAAs, 2.5 clinical overview, 2.7. 1 biopharmaceutics and associated analytical methods, 2.7.2 summary of clinical pharmacology studies, 2.7.3 summary of clinical efficacy, and/or 2.7.4 summary of clinical safety, 2.4 Nonclinical overview, 2.6 Nonclinical written and tabulated summaries 2.6.1 Introduction, 2.6.2 Pharmacology written summary, 2.6.3 Pharmacology tabulated summary, 2.6.4 Pharmacokinetic written summary 2.6.5 Pharmacokinetic tabulated summary, 2.6.6 Toxicology written summary, 2.6.7 Toxicology tabulated summary
Listed skills include Regulatory Affairs, Pharmaceutical Industry, Gmp, Fda, and 29 others.
Current workplace
Andre Pearson's current company
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University Of Pennsylvania (Gill Laboratory)
AeroLeads page
14 roles · 16 years
Andre Pearson work experience
A career timeline built from the work history available for this profile.
Principal Medical Regulatory Writer & Cmc Scientist Senior Manger
Current
Apr 2020 - Present
Project Manager
Current
Apr 2018 - Present
Principal Medical Writer And Cmc Scientist
Current
Mitsubishi Tanabe Pharma America
2018 - Present
~8 yrs 4 mos
Principal Medical Writer And Cmc Scientist At Mitsubishi Tanabe Pharma America
Current
Mitsubishi Tanabe Pharma America
2018 - Present
~8 yrs 4 mos
Cmc And Medical Writer At Indivior, Inc.
Current
2017 - Present
~9 yrs 4 mos
Regulatory Cmc Manager And Senior Medical Writer
Current
Sep 2015 - Present
Regulatory Affairs Manager With Pharmalex Usa
Current
Pharmalex
- Prepared and reviewed dossier-related source documentation, including technical transfer reports, protocols, drug product formulation development and process validation summary reports, and other study summary reports.
- Provided post-submission support in responding to CMC questions
- Collaborated with authors to write source documents participated in regular teleconference CMC organization project team meetings
- Coordinated with cross functional groups to compile source information to build dossier
- Communicated with Drug Product Development management
- Provided advice on content of information in different source documents
Sep 2015 - Present
Medical Regulatory Affairs Senior Writer (Remote)
CurrentProvided Regulatory CMC strategies.Authored, compiled, and reviewed CMC submissions in support of worldwide clinical and commercial applications for assigned products.Planned and provided written meeting requests and briefing packages for meetings with regulatory agencies and participated in the meetings.Collaborated with CMC functional groups to plan.
Jan 2014 - Present
Senior Cmc Regulatory Affairs Specialist
Current
Ipsen Biopharmaceuticals
Managed global programs with specific experience in post-approval CMC global regulatory submission.Provided and comprehensive understanding of CMC post approval guidance and regulation for global markets.Provided project management skills: handled diverse CMC projects and activities at different stages of criticality at any one time.Interpreted and.
Dec 2012 - Present
Ceo And Founder
Current
Biotech Generics Llc
- Experience in CMC(QbD), IND/NDA /ANDA/505(b)(2)/post marketing/ eCTD/documentation/submissions, pre marketing applications and subsequent amendments/supplements/CBEs. Stability report technical writing.
- Products: MACI® (autologous cultured chondrocytes), Carticel® ((autologous cultured chondrocytes), CUBICIN® (daptomycin for injection), CB-315 (Phase III), Zuplenz® (Ondansetron), Suboxone® (Buprenorphine/Naloxone)
Aug 2010 - Present
Ceo And Founder
Current
Biotech Generics Llc
Provided regulatory leadership, oversight and strategy in support of product/portfolio assignments for products in the post-approval lifecycle.Managed a small number of individual contributors who are responsible for their own portfolio of products.Responsible for developing and overseeing implementation of regulatory strategies and making decisions that.
2010 - Present
~16 yrs 4 mos
Eli Lilly Global Communications Principle Medical Writer
Eli Lilly - Imclone
- Responsible for the development of regulatory submission documents including briefing documents and slide sets to support health authority meetings, answers to health authority queries, special protocol.
- Responsible for managing a oncology clinical trial submission program which involved resolving inconsistencies between case report form data and the output of the clinical database, patient narratives, clinical study.
- Independently authored reviewed and revised regulatory documents, summary reports, and SOPs
- Contributed to the medical/scientific input given for the development of trial-related documents and processes which reside in other line functions; obtain approval from internal review boards. Collaborate with the.
Aug 2013 - Feb 2014
Senior Technical Writer
Responsible for managing analytical data, interpreting analytical data and creating preliminary stability reports.Analyzed trend stability data for drug substance and drug product.Evaluated stability data and created reports for submission to various authorities.Provided product stability reports and provided crucial product stability information to upper.
Sep 2012 - Nov 2012
2 education records
Andre Pearson education
Master Of Science (Msc), Chemistry
Wesleyan University
Bachelor Of Science (Bsc), Chemistry
Udc
FAQ
Frequently asked questions about Andre Pearson
Quick answers generated from the profile data available on this page.
What company does Andre Pearson work for?
Andre Pearson works for University of Pennsylvania (Gill Laboratory).
What is Andre Pearson's role at University of Pennsylvania (Gill Laboratory)?
Andre Pearson is listed as Principal Medical Regulatory Writer and CMC Scientist Senior Manger at University of Pennsylvania (Gill Laboratory).
What is Andre Pearson's email address?
AeroLeads has found 1 work email signal at @upenn.edu for Andre Pearson at University of Pennsylvania (Gill Laboratory).
What is Andre Pearson's phone number?
AeroLeads has found 10 phone signal(s) with area code 781, 617, 718, 607, 860, 206 for Andre Pearson at University of Pennsylvania (Gill Laboratory).
Where is Andre Pearson based?
Andre Pearson is based in New York City Metropolitan Area, United States, United States while working with University of Pennsylvania (Gill Laboratory).
What companies has Andre Pearson worked for?
Andre Pearson has worked for University Of Pennsylvania (Gill Laboratory), Celgene, Mitsubishi Tanabe Pharma America, Indivior, and Merck.
How can I contact Andre Pearson?
You can use AeroLeads to view verified contact signals for Andre Pearson at University of Pennsylvania (Gill Laboratory), including work email, phone, and LinkedIn data when available.
What schools did Andre Pearson attend?
Andre Pearson holds Master Of Science (Msc), Chemistry from Wesleyan University.
What skills is Andre Pearson known for?
Andre Pearson is listed with skills including Regulatory Affairs, Pharmaceutical Industry, Gmp, Fda, Validation, Biotechnology, Clinical Development, and Regulatory Submissions.
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