- Boehringer Ingelheim (Ridgefield, CT)
- …Fellow will: * Act as a company liaison with the US Food and Drug Administration. * Research information on regulatory CMC standards and departmental policies. ... Outlook, Word, PowerPoint, and Excel. + Foundational understanding of corporate structure, regulatory considerations and the drug development process in pharmacy… 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
- Otsuka America Pharmaceutical Inc. (Atlanta, GA)
- … 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
- 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
- The Estee Lauder Companies (Melville, NY)
- …and interpersonal skills. * Basic knowledge of chemistry and broad cosmetic/ drug regulatory experience preferred. * Fully proficient and experienced ... of ELC ingredients, formulas, and products. Takes part in enhancing formula regulatory review and ILN policies and SOPs supporting the GPS function independently… more
- MyFlorida (Tallahassee, FL)
- …related policies and procedures. Ensures conformance with the Food and Drug Administration (FDA) Manufactured Food Regulatory Program Standards (MFRPS), ... REGULATORY PROGRAM SPECIALIST - 42002977 (FOR INTERNAL AGENCY...provide the accommodation. The State of Florida supports a Drug -Free workplace. All employees are subject to reasonable suspicion… 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
- Bristol Myers Squibb (Indianapolis, IN)
- …Pharmacy, Public Health, Engineering or related field + Strong interest in regulatory affairs and drug development + Excellent organizational and communication ... RayzeBio aims to be the global leader in radiopharmaceuticals. **Position Summary** The Regulatory Affairs Intern will support the Regulatory Affairs team in… more
- AbbVie (Washington, DC)
- …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
- University of North Carolina- Chapel Hill (Chapel Hill, NC)
- …group is dedicated to developing innovative datasets and modeling approaches to support drug development and regulatory evaluation. We focus on two major ... patient demographics, and clinical trial data. 2. Modeling for Regulatory Science - Leveraging drug development and regulatory datasets to build models… more