- Parexel (Springfield, IL)
- …EU, CH, DE, AU) and non-US/Central EU markets, ensuring compliance with global regulatory requirements and supporting cross-functional teams in delivering ... 5 years of biotech/pharma industry experience, including 2+ years in labeling/ regulatory operations with global responsibility. * Experience leading teams… more
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- … leader responsible for envisioning, developing, and executing the company's global regulatory strategy to support clinical development, product approvals, ... Regulatory Leadership & Strategy * Develop, lead, and operationalize the global regulatory strategy across all development programs and marketed products. *… more
- Sumitomo Pharma (Springfield, IL)
- … strategies including management of IND and NDA submissions, FDA and other global regulatory interactions, as well as international submissions. In addition, the ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...and experienced leader for the position of **Vice President, Regulatory Affairs Oncology** . The candidate must be deeply… more
- Otsuka America Pharmaceutical Inc. (Springfield, IL)
- …environment. **Job Description** + Oversee the capture, review, and dissemination of global regulatory news, public commenting opportunities, new and updated ... programs. + Build professional network with key stakeholders outside of Global Regulatory Affairs to identify regulatory intelligence needs and strengthen… more
- The Clorox Company (Willowbrook, IL)
- …and Cosmetic Act (FD&C Act), Modernization of Cosmetics Regulation Act (MOCRA)], global regulatory frameworks (including European Union, Canada and Asia ... care and over-the-counter (OTC) drug products. This role independently leads regulatory activities, ensuring compliance with global regulations while enabling… more
- Parexel (Springfield, IL)
- …management experience is required. * Comprehensive understanding of regional and global regulatory requirements, guidelines, and processes. * Proven expertise ... Bring your expert knowledge of FDA regulatory requirements and guidelines to Parexel! We are...for change control and post-approval requirements. * Collaborate with global functions to obtain documentation aligned with local requirements.… more
- ManpowerGroup (Green Oaks, IL)
- …regulatory projects. This role ensures compliance with internal policies and global regulatory requirements and requires strong attention to detail, technical ... **Title:** Regulatory Affairs Associate **Location:** Lake County, IL or...Range:** $27-$29 per hour (W2) We are seeking a ** Regulatory Affairs Associate** to join one of our leading… more
- Otsuka America Pharmaceutical Inc. (Springfield, IL)
- …and clinical trial implementation and management. + Complete understanding of the global regulatory requirements. + Working knowledge of marketing and ... data management, and medical writing. + Complete understanding of the global regulatory requirements. Demonstrated experience in successful regulatory… more
- Otsuka America Pharmaceutical Inc. (Springfield, IL)
- …the product lifecycle meet Good Manufacturing Practices (GMP) and comply with global regulatory requirements, including DEA regulations. This role partners ... if applicable), ICH Q7 + Strong understanding of GMP requirements and global regulatory expectations for controlled substances. + Experience managing quality… more
- Otsuka America Pharmaceutical Inc. (Springfield, IL)
- …assigned compounds to drive alignment of labeling content and strategy. + Partner with Global Regulatory Affairs to ensure that all labeling is aligned with the ... activities related to all global labeling components. + Represent Global Labeling on product-specific Regulatory and Cross-Functional teams, as appropriate.… more