Eric Richards Email and Phone Number
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Successfully led substantial organizational changes in challenging environments. Commonly seen as far more than a “regulatory guy” - seen as strategic drug developer. Innovative, passionate, and open leadership style that has proven to inspire people to lead within and outside my function, and to follow me to several different companiesBroad global drug development experience from early to late stage to post-marketing, as a function head to individual contributor involving novel/novel combinations, CDx, IO, ADC and globally simultaneous submissions Six different new drugs approved in at least one major market (MEKINIST, TAFINLAR, TAGRISSO, TURALIO, VANFLYTA, ENHERTU) with numerous additional indications for OPDIVO and YERVOY. The fast ever drug development in oncology (TAGRISSO, FIH to approval 2 years, 8 months) and 2nd fastest biologics (ENHERTU)
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Senior Vice President, Head Of Medicine Development Leaders (Oncology)Gsk Apr 2024 - PresentBrentford, Middlesex, GbLeading a department of individuals who act the single point of accountability for medicines in the clinical stage oncology portfolio
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Senior Vice PresidentDaiichi Sankyo, Inc. Jun 2021 - Apr 2024Basking Ridge, Nj, UsAccountable for regulatory affairs in all indications (oncology and specialty medicine) in all regions. Responsible for the global regulatory strategy and operations to secure the approval and successful launch of indications for Daiichi Sankyo's portfolio of medicines -
Vice President, Oncology Head Regulatory AffairsDaiichi Sankyo, Inc. Jul 2017 - May 2021Basking Ridge, Nj, Us
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Executive Director, Global Regulatory ScienceBristol-Myers Squibb Feb 2016 - Jun 2017Lawrence Township, Nj, Us•Provides regulatory leadership to Immuno-oncology (IO) full development teams across solid tumor indications •Coaches and mentors Global Regulatory Team Leaders responsible for leadership of their respective IO solid tumor Full Development Teams•Leads Global Regulatory Team for IO lung/head and neck cancer full development team -
Senior Director, Global Regulatory Affairs, OncologyAstrazeneca 2014 - Jan 2016Cambridge, Cambridgeshire, Gb•Served as Global Regulatory Lead for TAGRISSO and AZD1775 - creating and leading regulatory strategy involving precision medicine (e.g. Companion Diagnostics) with novel/novel drug combinations in both advanced and early stage NSCLC and Ovarian Cancer•Led scientific advice/pre-submission meetings for TAGRISSO with FDA (CDER/CDRH), CHMP/Rapporteurs, PMDA, China CDE, TGA and Health Canada•Led submission team for TAGRISSO global marketing applications in record time (7.8 weeks from data to file) for the one of the fastest development times in history (2.7 years from FTIH to First Approval)•Submitted marketing applications to US, EU simultaneously followed by Japan and 4 additional countries within 3 months -
Director Global Regulatory AffairsGlaxosmithkline 2011 - 2014Brentford, Middlesex, Gb•Served as Global Regulatory Lead for MEKINIST, TAFINLAR, and the combination of both - creating and leading regulatory strategy across multiple indications involving precision medicine (e.g. Companion Diagnostics) with novel/novel drug combinations•Worked closely with clinical and commercial teams to develop a clinical development program that met the needs of Health Authorities and Reimbursement Agencies•Led regulatory matrix team in constructing regulatory strategy for several assets across multiple indications: e.g. melanoma, NSCLC, AML, NSCLC, CRC and Pancreatic cancer. •Led scientific advice/pre-submission meetings with FDA, EMA, Health Canada and PMDA for MEKINIST and TAFINLAR, as well as the novel/novel combination MEKINST+TAFINLAR•Led submission teams for several global marketing applications for both MEKINIST, TAFINLAR and the combination (NDA, MAA, NDS, Australian MAA) to successful approvals•Wrote request, and obtained the first official Pre-IND meeting (for MEKINIST) with China CDE conducted by GSK. Led preparations for and represented GSK centralized regulatory along with the Chief Regulatory Officer at Pre-IND meeting•Reviewed and approved marketing plans/pieces/launch activities
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Associate Director Global Regulatory Affairs (Us/Global Regulatory Lead)Glaxosmithkline 2006 - 2011Brentford, Middlesex, Gb•Served as lead contributor in reorganization of GSK Global Regulatory Structure; defining the role of GRL and regulatory matrix teams•Served as U.S. Regulatory Lead and eventually Global Regulatory Lead for ZOFRAN and casopitant leading the latter from Phase III through file; i.e. Pre-NDA, Pre-MAA, Application Review, preparation for Advisory Committee, etc. •Served as Global Regulatory Lead and eventually interim Project Leader for foretinib leading overall asset development•Served as Global Regulatory Lead for MEKINIST (trametinib) starting from pre-POC through Phase III initiation •Led regulatory collaborations with companion diagnostic company to develop CDx for MEKINIST and TAFNILAR – representing GSK at pre-IDE meetings•Conducted multiple due diligence assessments
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Manager/Senior Manager, UsraPfizer Jan 2002 - Oct 2006New York, New York, Us•Served as U.S. Regulatory Lead on four different teams: Celebrex, Relpax, Mirapex (co-promote) and Rebif (co-promote) providing promotional review and regulatory strategy for lifecycle management clinical development. •Reviewed and approved marketing plans/pieces/activities (including launch materials and T.V. commercials) and led interactions with DDMAC•Provided regulatory compliance training to Marketing, Sales, Physician Speakers and Clinical investigators
Eric Richards Skills
Eric Richards Education Details
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Harvard Business SchoolGeneral -
WaldenMph
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Temple UniversityQa/Ra
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The New SchoolMusical Theatre
Frequently Asked Questions about Eric Richards
What company does Eric Richards work for?
Eric Richards works for Gsk
What is Eric Richards's role at the current company?
Eric Richards's current role is Senior Vice President, Head Medicine Development Leaders GSK Oncology.
What is Eric Richards's email address?
Eric Richards's email address is er****@****ast.net
What is Eric Richards's direct phone number?
Eric Richards's direct phone number is +120235*****
What schools did Eric Richards attend?
Eric Richards attended Harvard Business School, Walden, Temple University, The New School.
What skills is Eric Richards known for?
Eric Richards has skills like Drug Development, Pharmaceutical Industry, Regulatory Affairs, Oncology, Regulatory Submissions, Clinical Development, Clinical Trials, Fda, Clinical Research, Biotechnology, Strategy, Ind.
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