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Jim Ure

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Sr Dir, Reg Aff, Head Resp, Oncology, Int Med

20 years in Regulatory Affairs, full life-cycle experience

  • MS in Biotechnology from Johns Hopkins
  • RAC certification. 
  • Spans the depth and breadth of DEVELOPMENT, CMC, COMMERCIAL, and REGULATORY INTELLIGENCE

Key Info

  • Job Title
    Sr Dir, Reg Aff, Head Resp, Oncology, Int Med
  • Top 3 Skills
    Full life cycle, Drug Development, TA Lead
  • Location
    Philadelphia, PA
  • Will relocate?
    No

Key Skills + Experience

PROFESSIONAL EXPERIENCE AND TRAINING OVERVIEW

Biopharmaceutical Regulatory Affairs professional with over 25 years of experience supporting drug development from pre-IND through post-approval. Lifelong learner.

  • Master of Science (MS) in Biotechnology from Johns Hopkins University
  • RAC certification from the Regulatory Affairs Professionals Society
  • Extensive experience in the global development and post-approval support of therapies
    • 20 years in Regulatory Affairs, full life-cycle experience
      • Small molecule drugs, biologics, and drug-device combination products
      • Rare (orphan, breakthrough, fast-track), specialty, and blockbuster indications
    • 8 years in GCP & GLP Regulatory Compliance; international auditor and trainer
    • 7 years in the biopharmaceutical / GMP laboratory
  • Previous employers include: AstraMerck/AstraZeneca, Auxilium, Centocor, Radius Health, Shire, Teva Branded Pharmaceuticals
  • Independent Regulatory Affairs Consultant experience with multiple clients
  • Developed Regulatory strategy and post-marketing support for small molecule drugs and biomolecules in various TAs, including: Cardiovascular, CNS, Dermatology, Endocrine/HRT, Osteoporosis, Cancer, GI, Immunology, Respiratory, Urology
  • Skills include performing development and commercial stage gap-analysis and
    due-diligence assessments and defining successful regulatory strategy for drug, biologic and combination products, while providing hands-on leadership and support
  • Regulatory experience spans the depth and breadth of four specialty areas:
    • Development RA: TA Lead, Health Authority Liaison & Team Lead for drugs and biologics. Responsible for product strategy, development, labeling, and approval
    • CMC RA: IND and post-marketing Change Control team member. Developed strategy, compiled CMC documents, led submissions and FDA interactions
    • Commercial RA: Led post-approval development, as well as review of scientific and promotional materials for market launches and post-approval activities
    • Regulatory Intelligence: Led International RI function. Assessed evolving drug regulations and policies. Interfaced with development teams and senior management to establish development strategy
  • Global Regulatory TA Head responsibilities have included:
    • Led RA Strategy, Labeling, Ads/Promo; 10 staff reports, over 40 products across Respiratory, Oncology, and Internal Medicine TAs. Ensured success throughout life cycle. RA signatory. Global portfolio and budget review
    • Provided advice to Regulatory staff for the content, strategy, and meeting preparation for international drug development programs in the US, EU, and Japan  
    • Responsible for RA TA oversight, and submission-level review and sign-off
       
  • Global Regulatory Lead (GRL) responsibilities have included:
    • GRL for Small Molecule (P2 to NDA for ADHD therapeutic)
    • GRL for Biologic (P2 to sBLA for Urologic orphan indication; PRO; co-primary endpoints, and REMs w/ETASU).
    • Lifecycle strategy and hands-on leadership of numerous INDs, NDA, and BLAs
    • Responsible for the application for a Breakthrough Therapy Designation request and successful defense of a pediatric orphan GI indication
    • Authored and reviewed hundreds of clinical, non-clinical and CMC documents
    • Led over 18 FDA-Sponsor Meetings for topics including: clinical development, CMC, nonclinical safety, pediatric development, cardiac/tQT, EOP2, Pre-NDA/BLA Formal Meetings; Pre-BLA FDA Advisory Meeting Preparation/Mock Review)
    • Negotiated study endpoints, Patient Reported Outcomes (PRO) measures requirements, product labeling and safety program (REMS) requirements
    • Managed the oversight and budget planning / reconciliation of Regulatory expert consultants (former FDA, industry leaders) and Reg. Ops. service providers
    • Assured regulatory activities met or exceeded corporate objectives; performed in accordance with approved procedures and compliance requirements

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