Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) discovers and develops new compounds that address unmet medical needs and advance human health. OPDC has numerous compounds in development to treat disorders in the neuroscience, oncologic, and cardio-renal therapeutic areas. OPDC is part of the Otsuka Group companies. For more information, visit www.otsuka-us.com.
Provides regulatory expertise and support for pre-clinical and clinical areas for investigational and marketed products; develops and oversees the strategic implementations of electronic regulatory submissions processes and systems.
Ensures that development of drugs is in accordance with global regulations in order to approve drugs quickly and smoothly within typical approval timeframes. Ensures that marketed products are supported with minimal questions and issues from the regulatory agencies. Establishes well-defined regulatory pathways and creates accurate and timely documents for IND and NDA and global submissions and final approval.
PhD/MS/DVM/MD/BS with 7-10 years of relevant drug development or preferably regulatory experience in the pharmaceutical or health-related industry, Helpful to have 3-5 years of supervisory or management (direct or indirect) experience and experience negotiating internal and external drug development and drug product issues.
RAC certification is a plus.
Requires strong working knowledge of the drug development process, drug laws, regulations, and guidelines.
Solid understanding of the FDA organization and ICH guidelines.
Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
Strong communication skills.
Excellent analytical skills and problem solving ability.