Steve Toth

Experience

1. Executive Director, Regulatory Affairs

   Anaptysbio

   Apr 2019 — Present · US

   Responsible for the creation and execution of global regulatory strategy for multiple monoclonal antibody products in development for the treatment of various dermatological disorders (e.g, atopic dermatitis, psoriasis diseases, ichthyosis, acne, hidradenitis suppurativa, and more), autoimmune disorders (vitiligo and systemic lupus erythematosus), rheumatoid arthritis, and ulcerative colitis.• Liaises with the CMC, QA, Clinical Development, Clinical Operations, Clinical Pharmacology and Toxicology, Nonclinical, and Research functions to effectively manage content necessary in support of regulatory applications for products in development. • Expert-level knowledge of the CTD content and organization as it pertains to regulations and guidance on drug substances, drug products, and placebos for both large and small molecules used in the U.S, Europe, Canada, Japan, China, and other major markets.• Expert-level knowledge of both large and small molecule drug substance and drug product manufacturing processes, analytical testing, stability study design, specification setting/requirements, and device/combination product development requirements.• Manages the authoring, preparation, and submission of technically complex content provided in BLAs, IND applications, IMPDs, clinical-related applications (e.g, CTAs, CTNs), and responses to queries from global ministries of health for monoclonal antibody products in development.• Represents the Regulatory Affairs department on multiple internal leadership and product development teams and committees, with global ministries of health and other governmental agencies, and with external partners (e.g, CROs, consultants, contractors).• Manages the roles and responsibilities for a Regulatory Affairs Sr. Manager level staff member.• Manages and coordinates the preparation of documentation required by contracted QPs for the release of clinical trial supplies in Europe.

Education

• Olivet Nazarene University

  MBA, Business Administration, Management and Operations

  2001 — 2003

• Illinois State University

  Bachelor of Science, Major: Biology - Minor: Chemistry

  1991 — 1995

Skills

• Validation
• Pharmaceutical Industry
• Sop
• Fda
• Regulatory Affairs
• Regulatory Submissions
• Clinical Trials
• Clinical Development
• Change Control
• Gmp