- Valent BioSciences (Libertyville, IL)
- …into new international markets, identifying best-in-class suppliers worldwide. + Analyze global market dynamics, regulatory landscapes, and cost drivers to ... international suppliers, ensuring alignment with corporate goals, sustainability standards, and regulatory compliance. + Negotiate, draft, and manage global … more
- Otsuka America Pharmaceutical Inc. (Springfield, IL)
- …Participates in audits of GMP Suppliers to ensure compliance with local and global requirements as well as applicable regulatory requirements. + Works ... areas across Otsuka Affiliates and Subsidiaries ensure Compliance with local and global requirements and regulatory requirements. + Interfaces with project teams… more
- Oracle (Springfield, IL)
- …are occurring and changing at an unprecedented rate, the success of large, complex global health companies requires regulatory leaders who are deeply steeped in ... applications to Health Canada, and other global submissions) across global market ensuring compliance with regulatory authorities. + Maintain documentation… more
- AbbVie (North Chicago, IL)
- …& Development (R&D) organizations. Represents CMC on teams such as product development, Global Regulatory Product Teams and Operations brand teams to negotiate, ... data and strategy to regulatory agencies + Responds to global regulatory information requests. + Develops strategies for CMC agency meetings, manages… more
- Astellas Pharma (Northbrook, IL)
- …Regulatory and HTA Engagement + Represent Astellas on all statistical matters in global regulatory interactions (eg, FDA, EMA, PMDA). + Guide preparation of ... work are encouraged to apply. **Purpose and Scope:** The Global Statistical Lead (GSTATL) for Solid Tumor Oncology is...external engagement. The GSTATL plays a key role in regulatory and payer strategy, as well as internal governance… more
- Otsuka America Pharmaceutical Inc. (Springfield, IL)
- …scientific and clinical resource for cross-functional colleagues including Clinical Development, Global Integrated Evidence & Innovation, Regulatory and ... scientific consistency and alignment across functions (eg, R&D, Clinical, Global Medical Affairs) + Provide high-quality scientific/clinical input and review… more
- Otsuka America Pharmaceutical Inc. (Springfield, IL)
- …approaches. + Ensure training content is accurate, current, and aligned with global regulatory requirements (FDA, EMA, ICH). **Compliance & Risk Management** ... senior leader within the Learning Center of Excellence under Global Quality. This role is responsible for developing and...global GxP training strategy to ensure compliance with regulatory requirements and foster a strong quality culture across… more
- Parexel (Springfield, IL)
- … drug safety regulations and guidelines + Maintaining an awareness of global regulatory requirements, reporting obligations and organizing workload to ensure ... while tackling complex safety evaluations that directly impact patient wellbeing and regulatory compliance. **About the Role** As a **Senior Physician in Patient… more
- Oracle (Springfield, IL)
- …software, ensuring vulnerability management and cybersecurity compliance with FDA and global regulatory expectations. + Apply the organization's Risk-Based ... for regulated medical devices. This role bridges product development, regulatory , and enterprise architecture functions-ensuring that device software solutions are… more
- Otsuka America Pharmaceutical Inc. (Springfield, IL)
- …relevant company SOPs, GPP (Good Publication Practices), ICMJE guidelines, and global regulatory /legal requirements, establishing governance frameworks to ensure ... Collaborate with the CNS Medical BU Lead and cross-functional teams (eg, Global Integrated Evidence & Innovation, Clinical Development, Regulatory , Commercial)… more