- Kelly Services (Thousand Oaks, CA)
- …research environment. + Stay abreast of the latest scientific advances in CNS drug delivery, bioanalysis, and regulatory frameworks to ensure research practices ... Senior Scientist/Principal Scientist - CNS Drug Delivery **Job Summary:** Our client is a...join a highly dynamic team dedicated to advancing CNS drug delivery technologies. We are seeking a Senior Scientist/Principal… more
- Lilly (Indianapolis, IN)
- …and updating approved global product registrations for drug substances and drug products. + Utilizes specialized scientific and regulatory expertise to ... knowledge in drug development including API, or Drug Product or Analytical + Demonstrated CMC regulatory... Drug Product or Analytical + Demonstrated CMC regulatory experience **Additional Information** + This role is based… more
- Otsuka America Pharmaceutical Inc. (Bismarck, ND)
- … strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription … more
- Lilly (Indianapolis, IN)
- … drug /device clinical development and knowledgefromhealth authorities such as regulatory policies, regulatory precedents, trends, and emerging regulatory ... scientific degree (ie, PhD, PharmD) and 8+ years Industry-related experience in regulatory affairs and/or drug development experience OR + Bachelor's degree… more
- Takeda Pharmaceuticals (Boston, MA)
- …requirements, beyond EU/US. who has an understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market ... support. Who has a proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams. **How you… more
- Takeda Pharmaceuticals (Boston, MA)
- …meetings, international experience preferred. + Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and ... post-market support. + Proven ability to provide strategic regulatory guidance to drug development, registration, and post-market support teams. + Able to deal… more
- Fresenius Medical Center (Waltham, MA)
- …across multiple regions (FDA, EMA, HC, etc.). + Strong expertise in navigating regulatory pathways for drug strategy, from preclinical through post-market. + ... AND SCOPE:** Responsible for leading the strategic direction and execution of regulatory strategies for our global pharmaceutical portfolio. This position plays a… more
- Ascendis Pharma (Palo Alto, CA)
- …developing regulatory affairs strategies + Preferred experience with a drug device combination products + Extensive regulatory experience including IND/CTA, ... in Endocrinology Rare Disease and Oncology. The Sr. Director, Regulatory Affairs will serve as the therapeutic area head...intellect, and an understanding of the business aspects of drug development. At a personal level, the company is… more
- AbbVie (North Chicago, IL)
- …drug development, including on clinical trial design and study requirements, regulatory exclusivities, orphan drug designations, and combination products, and ... R&D organization in navigating enterprise-critical issues in an evolving legal and regulatory environment as we work to bring new, innovative products to patients.… more
- Merck (West Point, PA)
- …model-informed regulatory framework to impact strategies and decisions of drug discovery and development teams.Collaborate with other functional areas, as well ... of increasing responsibility and independence in a similar role in pharmaceutical drug development, regulatory agency, or academia. + Educational background in… more