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9 years analytical chemistry, 24+ years in Regulatory Affairs-CMC (pharmaceutical and biologics).Strong knowledge of solid/oral, sterile pharmaceuticals, and biological products. Manage CMC dossiers in USA, EU, Canada, Rest of World (ROW), as well as growth markets in the Lat-Am and Asia-Pacific regions (China, Japan).Specialties: Developing regulatory strategies and authoring of CMC submissions (IND/IMPD, NDA/MAA, supplements/variations, US AnnuaI Reports/renewals). Has years of experience with direct US FDA contact. In 2004, lead successful face-to face CMC negotiations in Beijing, China with the Chinese Health Authorities. Has extensive experience in working with Japanese marketing partners.
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RetiredFrom Pfizer Mar 2022 - Present
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Director, Regulatory Affairs CmcPfizer Nov 2006New York, New York, UsManaged 6 direct reports (3 permanent/3 contractors) and global CMC activities for pharmaceuticals. Managed compliance audit program to ensure global registrations are aligned with plant practices. Provides CMC support for pharmaceuticals and biologicals (including the filing for a new ADC). -
Sr.Manager, Regulatory Affairs CmcCentocor Nov 2004 - Nov 2006UsManaged 3 direct reports. Supported registration of biologics in USA and ROW, with strong focus on China and Japan. Led successful face-to face CMC negotiations in Beijing, China with Health Authorities. Worked with Japanese marketing partner. -
Manager, Regulatory Affairs CmcMerck 1996 - Nov 2004Managed 4 direct reports, coordinating CMC activities worldwide for solid oral, ophthalmic and sterile pharmaceutical products.
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ScientistSanofi-Aventis (Formerly Rhone Poulenc Rorer) 1992 - 1996R&D Analytical method development and validation for NCEs/commercial products (tablets, capsules, creams, inhalers, transdermal patches). Provided documentation for NDA filings.
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Scientist, AnalyticalSmithkline Beecham 1989 - 1992Brentford, Middlesex, GbAnalytical process development for API manufacture. -
ScientistReed & Carnrick, Block Drug 1987 - 1989Analytical method development. Drug product stability testing.
Grace Rabano Skills
Grace Rabano Education Details
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Lehigh UniversityChemistry (Graduate Level) -
Temple UniversityRegulatory Affairs
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Rutgers UniversityChemistry
Frequently Asked Questions about Grace Rabano
What company does Grace Rabano work for?
Grace Rabano works for Pfizer
What is Grace Rabano's role at the current company?
Grace Rabano's current role is Retired.
What is Grace Rabano's email address?
Grace Rabano's email address is gr****@****zer.com
What is Grace Rabano's direct phone number?
Grace Rabano's direct phone number is +121257*****
What schools did Grace Rabano attend?
Grace Rabano attended Lehigh University, Temple University, Rutgers University.
What skills is Grace Rabano known for?
Grace Rabano has skills like Regulatory Affairs, Fda, Pharmaceutical Industry, Validation, Cmc, Pharmaceutics, Regulatory Submissions, Analytical Chemistry, Technology Transfer, Gxp, Gmp, Change Control.
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