Lincy Thomas George

Lincy Thomas George Email and Phone Number

Vice President, Oncology Global Regulatory Affairs | Sanofi | Purpose Driven Leader @ Sanofi

Lincy Thomas George's Contact Details

Lincy Thomas George personal email

n/a

Lincy Thomas George's Current Company Details

Sanofi

Vice President, Oncology Global Regulatory Affairs | Sanofi | Purpose Driven Leader

Lincy Thomas George Work Experience Details

  • Vice President - Global Regulatory Affairs - Oncology, Specialty Care Business Unit
    Sanofi ['Jul 2023', 'Present']
    Paris, France, Fr
    Global head for oncology regulatory affairs leading team covering hematology, solid tumors and cell therapy portfolio.
  • Vice President, Global Regulatory Affairs
    Simcere Pharmaceutical Group ['Aug 2022', 'May 2023']
    南京市玄武区, 江苏, Cn
    Oversee global regulatory strategy for oncology, immunology, CNS portfolio. Support BD&L activities. Member of leadership team at Boston Innovation Center.
  • Executive Director - Oncology Team Lead
    Bristol Myers Squibb ['Jan 2021', 'Jul 2022']
    Lawrence Township, Nj, Us
    Deputy TA Head Oncology - assist with talent planning and development for oncology regulatory associates and participate in GRS organizational wide activities and workstreams (internal and external facing). Participate in enterprise wide initiatives and due diligence activities. Chair late stage oncology regulatory lessons learned meetings. Oversee team of regulatory associates working on Opdivo/Yervoy program and filings across various tumor types including external collaboration programs (e.g. Nektar). Pediatric regulatory representative for internal activities (peds regulatory team and peds center of excellence) and external facing (Bio).
  • Executive Director, Gtal
    Novartis ['Oct 2018', 'Jan 2021']
    Basel, Baselstadt, Ch
    Global Regulatory Therapeutic Area Lead - Melanoma (Oct 2018 - Jan 2021)Senior Global Program Regulatory Director for Tafinlar & Mekinist & IO- provide global regulatory leadership for programs in melanoma,NSCLC, rare diseases, tumor agnostic, pediatrics- regulatory oversight for immuno-oncology PD1 development (Spartalizumab)Global Program Regulatory Director for PI3kinase team (June 2016-March 2017)- provide regulatory leadership for development programs (alpelisib, buparlisib) in breast cancer and other indications in development (e.g. Head and Neck cancer)Global Program Regulatory Director for Arzerra (monoclonal antibody for CLL)- led team in regulatory interactions and US approval for extended CLL treatment indication- led team in global regulatory submission strategy, HA meeting preparations and dossier compilation for refractory/relapsed CLL indication
  • Director
    Novartis ['Mar 2012', 'Sep 2015']
    Basel, Baselstadt, Ch
    Regulatory lead for Afinitor breast cancer, NET, renal cancer, TSC-SEGA/AML/seizures programs and other LCM indications. Responsible for leading team through regulatory interactions and submission planning. Responsible for global promotional review of marketing and field-based medical materials.
  • Senior Associate Director
    Novartis ['Apr 2010', 'Mar 2012']
    Basel, Baselstadt, Ch
    US Regulatory Lead for Afinitor- responsible for RCC, NET and breast cancer programs (global & US)- filed sNDA and secured regulatory approvals for pNET and HR+ Breast Cancer indications- responsible for HCC and TSC-SEGA/AML and seizures programs (US) - May 2013 onwards- group lead for US FDA related activities across entire program- review all global promotional materials and US field based scientific materials
  • Associate Director
    Novartis ['Apr 2007', 'Mar 2010']
    Basel, Baselstadt, Ch
    2009: US Regulatory Lead for Exjade2008: Exjade Brand Marketing Job Rotation- Launched free serum ferritin screening program - Launched Iron Toxicity News (professional education program)- Presented key marketing programs/tactics at national sales mtng- Support promotional programs to drive brand strategy and sales targetsOncology Drug Regulatory Affairs (April 2005 - March 2010)- Responsible for US and global promotional review of Exjade - Lead team through regulatory activities (FDA meetings, labeling negotiations, post-marketing commitment fulfillment) - Provide input for life cycle management activities.- Global DRA representative for oncology compound in development (input into development strategy and lead team in FDA interactions)- Representative for DRA taskforces and participate in due diligence activities- Mentor junior regulatory colleagues and PharmD Fellows
  • Senior Regulatory Manager
    Novartis ['Apr 2005', 'Apr 2007']
    Basel, Baselstadt, Ch
    - Support regulatory approval of Exjade in U.S. and worldwide- Regulatory reviewer of Zometa promotional materials
  • Post-Doctoral Fellow - Rutgers/Novartis Pharmaceutical Fellowship Program
    Novartis ['Jul 2003', 'Mar 2005']
    Basel, Baselstadt, Ch
    Transplant & Immunology Business Unit (July 2004-March 2005)- DRA manager for Neoral (cyclosporine) - Provide support for compounds in developmentFDA Rotation - Clinical Pharmacology Reviewer - AntiVirals Division- Reviewed clinical pharmacology study protocols and reports- Participated in multiple FDA meetings with various sponsors developing anti-viral drugs (e.g. HIV/AIDS, Hepatitis)Novartis Consumer Health - OTC Division (July 2003-June 2004)- Provide regulatory support for 5 project teams (Lamisil franchise and analgesia product)Rutgers University - Assistant Professor- Coordinated Industrial Practice Management elective course- ASHP Midyear Committee Chair (2004) - lead conference recruitment efforts with 13 partner companies- Participated in 'Shape it Up' - educational outreach program- Guest lecturer for elective courses at Ernest Mario School of Pharmacy
  • Registered Pharmacist
    Cvs Pharmacy ['Jun 2003', 'Jun 2005']
    Woonsocket, Ri, Us

Lincy Thomas George Education Details

  • Fordham Gabelli School Of Business
    Marketing And Business Management 2009 - 2012
  • Rutgers University
    Pharmacy

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Frequently Asked Questions about Lincy Thomas George

What company does Lincy Thomas George work for?

Lincy Thomas George works for Sanofi

What is Lincy Thomas George's role in his/her workplace?

Lincy Thomas George's role in his/her workplace is Vice President, Oncology Global Regulatory Affairs | Sanofi | Purpose Driven Leader.

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What schools did Lincy Thomas George attend?

Lincy Thomas George attended Fordham Gabelli School Of Business, and Rutgers University .

What is Lincy Thomas George's role in his/her workplace?

Lincy Thomas George has skills like Oncology, Regulatory Affairs, Pharmaceutical Industry, Leadership, Fda, Clinical Trials, Cross Functional Team Leadership, Marketing Strategy, Healthcare, Clinical Development, Market Research, Regulatory Submissions, Drug Development, Immunology, Biotechnology, U.s. Food And Drug Administration, and Pharmaceuticals.

Who are the industry peers of Lincy Thomas George at other companies?

Lincy Thomas George's peers at other companies are Victor Paulus, Kimberly Burns, John Roth, Vanessa D., Sagy Hassan, Pharmd, and Selina(Shiming) Feng, Rac. and Declan Kelly. Lincy Thomas George's peers at other companies are Victor Paulus, Kimberly Burns, John Roth, Vanessa D., Sagy Hassan, Pharmd, and Selina(Shiming) Feng, Rac. and Declan Kelly.