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Elijah Tan is listed as Principal Consultant / Founder at Red Rock Regulatory Consultants, LLC at Red Rock Regulatory Consultants, LLC, based in Henderson, Nevada, United States. AeroLeads shows a work email signal at address.com, phone signal with area code 215, 415, 610, and a matched LinkedIn profile for Elijah Tan.
Elijah Tan previously worked as Principal Consultant / Founder at Red Rock Regulatory Consultants, Llc and Director of Regulatory Affairs at Coherus Biosciences. Elijah Tan holds M.S., Pharmaceutical Quality Assurance/Regulatory Affairs from Temple University.
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AeroLeads found 1 current-domain work email signal for Elijah Tan. Compare company email patterns before reaching out.
Regulatory affairs consultant with 2 decades of combined experience in CMC for biologics (including recombinant biologics, biosimilars and advanced therapy) and small molecules. RAC(US)-Certified 2008, RAC(EU)-Certified in 2009.
Listed skills include Fda, Regulatory Affairs, Biotechnology, Gmp, and 37 others.
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SUMMARY: Demonstrated success in defining and implementing global regulatory CMC strategies to advance biological products including orphan products from preclinical studies to global marketing approvals (e.g. US, EU, Japan, Canada, Australia, etc.). Two decades of industry experience across multiple disciplines (immunology, oncology, hematology.
Redwood City, CA, US
1) Global Regulatory Leader responsible for global licensing of adalimumab biosimilar. Responsible for all aspects (administrative, CMC, nonclinical and clinical) of the BLA/MAAs. 2) Led multiple health authority meetings including a pre-BLA meeting. Led/authored several EUCentralized Scientific Advice meeting packages and a pediatric study plan (iPSP).3).
South San Francisco, California, US
1) Supported 6 development products spanning multiple indications (immunology, dermatology, ophthalmology, and oncology) and a commercial biological product for intraocular administration. Acted as the global technical regulatory leader on 4 early-phase and late-phase development products and as technical regulatory advisor on 2 pre-clinical development.
Cambridge, MA, US
Global RA-CMC strategic lead for a recombinant-derived coagulation factor product which achieved marketing approvals in multiple countries (US, Canada, Australia, etc.). Led BLA/NDS/MAA submission teams and developed strategy for pre-authorization consultation with global health authorities. Led CMC-focused pre-BLA and other meetings with CBER.
Cambridge, MA, US
Responsible for development and implementation of global regulatory strategy (clinical, non-clinical and CMC) for a recombinant derived coagulation factor product under the Biogen Idec Hemophilia business unit.Accomplishments/Activities:1) Led preparation of FDA Type B meeting briefing document on clinical study design / Phase 3 clinical protocol2) Primary.
Provided regulatory and quality consulting for pharmaceutical, biotechnology, and medical device companies.*Regulatory consultation and CTA/IND submission management for a recombinant peptide and a synthetic peptide product. *Regulatory/quality consultation for Class II (Class IIb for EU) medical devices including 510(k) strategy, device licencing.
New York, New York, US
1) Compliance assessment of CMC dossiers/information registered with global health authorities for several key Wyeth Biotech products as part of a corporate initiative to streamline regulatory processes.2) High-level CMC content review and regulatory gap assessment for global biologics clinical trial, marketing authorization, and post-approval variation.
Boston, MA, US
Regulatory Affairs-Chemistry, Manufacturing & Control (CMC) strategist for small molecule investigational new drug candidates. Duties included consultation on, development of, and implementation of regulatory CMC strategy for product development and commercialization. Overall project lead and ultimately responsible for CMC submission content.
Boston, MA, US
Lead quality assurance and regulatory-CMC liaison of Pharmaceutical Development (PharmDev) division:* Led PharmDev Quality Lead Team (QLT) meetings.* Primary author for manufacturing sections of clinical trial applications.* Key functional player in design, implementation and optimization of various corporate-level quality systems including change.
Rahway, New Jersey, US
Quality Administration (August 2004 to August 2005)Analytical Method Development (Jan 2000 to Aug 2004)
Quick answers generated from the profile data available on this page.
Elijah Tan works for Red Rock Regulatory Consultants, LLC.
Elijah Tan is listed as Principal Consultant / Founder at Red Rock Regulatory Consultants, LLC at Red Rock Regulatory Consultants, LLC.
AeroLeads has found 1 work email signal at @address.com for Elijah Tan at Red Rock Regulatory Consultants, LLC.
AeroLeads has found 5 phone signal(s) with area code 215, 415, 610 for Elijah Tan at Red Rock Regulatory Consultants, LLC.
Elijah Tan is based in Henderson, Nevada, United States while working with Red Rock Regulatory Consultants, LLC.
Elijah Tan has worked for Red Rock Regulatory Consultants, Llc, Coherus Biosciences, Genentech, Biogen Idec, and Tan Regulatory Services.
You can use AeroLeads to view verified contact signals for Elijah Tan at Red Rock Regulatory Consultants, LLC, including work email, phone, and LinkedIn data when available.
Elijah Tan holds M.S., Pharmaceutical Quality Assurance/Regulatory Affairs from Temple University.
Elijah Tan is listed with skills including Fda, Regulatory Affairs, Biotechnology, Gmp, Pharmaceutical Industry, Drug Development, Quality System, and Sop.
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