Grant S. Griffin, Drsc, Fraps, Rac

Grant S. Griffin, Drsc, Fraps, Rac Email and Phone Number

Chicago, IL, US
Grant S. Griffin, Drsc, Fraps, Rac's Location
Greater Chicago Area, United States, United States
Grant S. Griffin, Drsc, Fraps, Rac's Contact Details

Grant S. Griffin, Drsc, Fraps, Rac work email

Grant S. Griffin, Drsc, Fraps, Rac personal email

n/a
About Grant S. Griffin, Drsc, Fraps, Rac

A regulatory affairs executive in the pharmaceutical and biotechnology industry with 18 years of health care experience, 14 years of experience in regulatory affairs, a Doctor of Regulatory Science (DRSc), and who is a Fellow of the Regulatory Affairs Professionals Society (FRAPS). Experience driving expedited regulatory approvals and expanded indications; building the company product pipeline and influencing the regulatory environment; and building collaborative relationships with health authorities, the CEO, and the Board of Directors to provide transformative therapeutics to patients in need.

Grant S. Griffin, Drsc, Fraps, Rac's Current Company Details
No Patient Left Behind

No Patient Left Behind

View
Fellow
Chicago, IL, US
Employees:
82
Grant S. Griffin, Drsc, Fraps, Rac Work Experience Details
  • No Patient Left Behind
    Fellow
    No Patient Left Behind
    Chicago, Il, Us
  • Griffin Regulatory Llc
    Griffin Regulatory Llc
    Greater Chicago Area
  • Tract Therapeutics, Inc.
    Regulatory Affairs Consultant
    Tract Therapeutics, Inc. May 2023 - Present
  • Ohio Medical
    Medical Device Regulatory Consultant
    Ohio Medical Sep 2024 - Dec 2024
    Gurnee, Il, Us
  • Eton Pharmaceuticals, Inc
    Executive Director, Regulatory Affairs
    Eton Pharmaceuticals, Inc Apr 2024 - Jul 2024
    Deer Park, Il, Us
  • Ccs Associates, Inc.
    Senior Regulatory Scientist
    Ccs Associates, Inc. Nov 2023 - Mar 2024
    San Jose, Ca, Us
  • University Of Southern California
    Guest Lecturer
    University Of Southern California Oct 2023 - Oct 2023
    Los Angeles, Ca, Us
    "Clinical Trials of Drugs: History and Requirements," MPTX 511: Introduction to Medical Product Regulation
  • Harmony Biosciences
    Senior Director, Regulatory Affairs
    Harmony Biosciences Mar 2022 - Apr 2023
    Plymouth Meeting, Pa, Us
    Recruited to lead regulatory due diligence evaluations and support clinical development programs for an existing approved product, pitolisant.● Led regulatory due diligence evaluations of multiple drugs for rare neurological diseases to potentially expand the product pipeline, driving one of three pillars of the corporate growth strategy. ● Advanced existing development programs for pitolisant in idiopathic hypersomnia, Prader-Willi syndrome, and myotonic dystrophy, and potential development programs for HBS-102.● Established war room FDA inspection readiness.
  • Tract Therapeutics, Inc.
    Regulatory Affairs Consultant
    Tract Therapeutics, Inc. Mar 2022 - May 2022
    Supported projects at the request of TRACT and with the permission of Harmony Biosciences.
  • Tract Therapeutics, Inc.
    Director Of Regulatory Affairs
    Tract Therapeutics, Inc. Jul 2019 - Mar 2022
    Recruited to serve as Head of Regulatory Affairs and lead the development of TRK-001, a cellular therapy that involves the selection and expansion of a patient’s own naturally occurring T regulatory cells (Tregs) for the prevention of graft rejection in solid organ transplant.● Qualified the company for incentives, including tax credits for qualified clinical trials, exemptions from user fees (e.g., $3,117,218 in Fiscal Year 2022), and a potential 7 years of market exclusivity after approval by obtaining Orphan Drug Designation.● Optimized development programs by generating internal product development plans (PDPs) that included potential expedited programs, including expedited development and review, intensive guidance from FDA, organizational commitment from FDA, rolling review, and a shorter review (6 months instead of 10 months) of a marketing application.● Positioned the company to raise capital to finance development through marketing approval by leading initial technology transfer of TRK-001.● Represented the company within the Alliance for Regenerative Medicine (ARM), advising that the US Government Relations and Policy Committee must collaborate with the US Regulatory Committee before pursuing changes to existing legislation that may impact FDA.● Established an initial company quality system to comply with FDA and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) requirements.
  • Abbvie
    Manager, Regulatory Affairs, Global Regulatory Strategy, Us And Canada
    Abbvie Sep 2015 - Jul 2019
    North Chicago, Illinois, Us
    Promoted to lead pediatric and post-approval FDA regulatory strategy, support pre-approval FDA regulatory strategy, advise Health Canada regulatory strategy, and manage Investigational New Drug (IND) and New Drug Application (NDA) submissions and timelines for MAVYRET® (glecaprevir/pibrentasvir) for the virologically curative treatment of patients with chronic hepatitis C virus (HCV) infection. Also assigned on a part-time basis to analyze the impact of evolving regulations and guidance for internal stakeholders and help establish company positions on regulatory policy topics at trade associations.● Obtained New Drug Application (NDA) approval 11 days prior to the Priority Review Prescription Drug User Fee Act (PDUFA) date. From 2017-2019, Mavyret (glecaprevir/pibrentasvir) was prescribed to approximately 100,000 patients with chronic HCV in the US and generated approximately $3.36B in revenue.● Obtained FDA Priority Review and sNDA approval and Health Canada Priority Review for adolescent patients. Advised pre-sNDS meeting teleconference to gain agreement with Health Canada. Nominated for AbbVie Inc. President’s Award. Obtained an early sNDA approval with safety and efficacy data from the HCV/HIV-1 coinfection study and liver and renal transplant study.● Qualified the company for incentives, including tax credits for qualified clinical trials, exemptions from user fees (e.g., $2,588,478 in Fiscal Year 2019), and a potential 7 years of market exclusivity after approval.● Qualified the company for pediatric exclusivity, which attaches 6 months of additional exclusivity to all dosage forms and all indications with the same active moiety as the drug studied and attaches to the end of all existing marketing exclusivity.● Advanced the regulatory policy positions of the company at the outset of Prescription Drug User Fee Act (PDUFA) VII negotiations.
  • Abbvie
    Regulatory Affairs Contractor, Us And Canada Area And Affiliate Strategy, Oncology
    Abbvie Aug 2015 - Sep 2015
    North Chicago, Illinois, Us
  • Abbvie
    Regulatory Affairs Contractor, Submission Operations And Publishing
    Abbvie Jan 2013 - Aug 2015
    North Chicago, Illinois, Us
  • Abbott
    Regulatory Affairs Contractor, Development Regulatory
    Abbott Jul 2010 - Dec 2012
    Abbott Park, Illinois, Us
  • Chicago Institute Of Neurosurgery And Neuroresearch
    Clinical Research Coordinator
    Chicago Institute Of Neurosurgery And Neuroresearch Aug 2007 - Jul 2010
  • Evanston Northwestern Healthcare
    Patient Care Technician
    Evanston Northwestern Healthcare May 2006 - Aug 2007
    Evanston, Il, Us

Grant S. Griffin, Drsc, Fraps, Rac Skills

Writing Regulatory Intelligence Clinical Trials Medical Writing Planning Allied Health Strategist Chemistry Draft Students Clinical Research Processors Ctms Oracle Rac Regulatory Affairs Mentoring Digital Preservation U.s. Food And Drug Administration Oversight Dia Specimen Collection Failure Protocol Nda Wound Care Batch Processing Third Party Nih Japan Assessment Neurosurgery Cmc Management Ostomy Care Adherence Text Editing Outsourcing Science Catheters Regulatory Science Sop Worksheets Metrics Depot Institutional Keys Aid Quality Patient Care Auditing Physics Site Initiation Source Ethics Public Speaking Defense Respiration Approvals Collaborative Korea Drug Product Cros Gmp Networking Education Virology Software Documentation Publishing Healthcare Combination Products Reports Strategy Template Pmas Lifesciences Boot Camp Medicine Phlebotomy Testing Drug Development Training Supplements Patient Humanitarian Regulatory Submissions Respiratory Therapy Surveying Acrp Conferences Documentation Analytical Skills Trains And Add Rails Quality Control Research System Monitoring Tube Ema Chicago London Los Angeles Raps Business Partnering Notification Coordination Ectd Stroke Fix Protocol Accountability Adverse Events Blood Glucose Communication Life Sciences Advertising European Union Strategic Planning Crfs Safety Privacy Law Regulatory Requirements Operations Drafting Service Quality Spl Project Planning Ing Data Driven Testing Contractual Agreements Expired Toro Iowa Case Report Forms Linkedin Vienna Responsibility Data Sharing Feeding General Correspondence Therapists Regulations Labelling International Art Cro Obtain Biology Transparency Trial Management Structured Finance History Russian Forms Irb Reviews Regulatory Electronics Ich Guidelines Disclosure Guidelines Medical Devices Technical Writing Compliance Pharmacovigilance Billing Annual Reports Aptitude Continuing Care Canada Pharmaceutics Patient Care Topic China Biologics Invoicing Nursing Phi Beta Kappa Inorganic Chemistry Pharmaceutical Industry Knowledge Sharing Templates Amendments Fda Evaluation Tabs Cover Letters Mhra

Grant S. Griffin, Drsc, Fraps, Rac Education Details

  • Harvard Law School
    Harvard Law School
    Law
  • Harvard Medical School
    Harvard Medical School
    And Immunology (50 Weeks)
  • University Of Colorado Law School
    University Of Colorado Law School
    Mini Law School (14 Weeks)
  • University Of Southern California
    University Of Southern California
    Regulatory Science
  • University Of Southern California
    University Of Southern California
    Regulatory Science
  • University Of Iowa
    University Of Iowa
    Russian (With Honors) And History (With Honors)

Frequently Asked Questions about Grant S. Griffin, Drsc, Fraps, Rac

What company does Grant S. Griffin, Drsc, Fraps, Rac work for?

Grant S. Griffin, Drsc, Fraps, Rac works for No Patient Left Behind

What is Grant S. Griffin, Drsc, Fraps, Rac's role at the current company?

Grant S. Griffin, Drsc, Fraps, Rac's current role is Fellow.

What is Grant S. Griffin, Drsc, Fraps, Rac's email address?

Grant S. Griffin, Drsc, Fraps, Rac's email address is gr****@****vie.com

What schools did Grant S. Griffin, Drsc, Fraps, Rac attend?

Grant S. Griffin, Drsc, Fraps, Rac attended Harvard Law School, Harvard Medical School, University Of Colorado Law School, University Of Southern California, University Of Southern California, University Of Iowa.

What are some of Grant S. Griffin, Drsc, Fraps, Rac's interests?

Grant S. Griffin, Drsc, Fraps, Rac has interest in Clinical Trial Data Disclosure, Entrepreneurship, Regulatory Affairs, Education, Foreign Languages, Science And Technology, Arts And Culture, Neuroscience, Health.

What skills is Grant S. Griffin, Drsc, Fraps, Rac known for?

Grant S. Griffin, Drsc, Fraps, Rac has skills like Writing, Regulatory Intelligence, Clinical Trials, Medical Writing, Planning, Allied Health, Strategist, Chemistry, Draft, Students, Clinical Research, Processors.

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