- Dentsply Sirona (Milford, DE)
- …business relationships. + Manages day to day activities for less senior Regulatory Affairs professionals, including but not limited to mentoring, coaching, ... Education: + Bachelor's degree in a relevant field, such as life sciences, regulatory affairs , or a related discipline. + Regulatory Certification (such as… more
- Otsuka America Pharmaceutical Inc. (Dover, DE)
- …with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- Otsuka America Pharmaceutical Inc. (Dover, DE)
- **Job Summary** The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global ... with other local and/or global functional units [OPC CMC Global Regulatory Affairs , Global Regulatory Strategy, Manufacturing facilities, Global Quality,… more
- Cardinal Health (Dover, DE)
- **_What Regulatory Affairs contributes to Cardinal Health_** Regulatory provides regulatory affairs and product development consulting services to ... submissions as well as clinical research and manufacturing process consulting. Regulatory Affairs plans, coordinates and implements regulatory strategies… more
- Parexel (Dover, DE)
- Join us as a **Global Labeling Operations Manager ** , where you'll work alongside a large, dedicated client team to drive impactful labeling operations across global ... DE, AU) and non-US/Central EU markets, ensuring compliance with global regulatory requirements and supporting cross-functional teams in delivering accurate, timely,… more
- Otsuka America Pharmaceutical Inc. (Dover, DE)
- The Manager , Contracts (Non-HCP SOWs) is an important role within the Medical Excellence & Operations team within Global Medical Affairs . This role is ... for end-to-end management of contracts that support Global Medical Affairs operations, excluding those with healthcare professionals or organizations. This… more
- Otsuka America Pharmaceutical Inc. (Dover, DE)
- The Senior Manager , External Engagement Strategic Planning will play a critical role in shaping and executing strategic initiatives that enhance the impact of ... Medical Affairs external stakeholder engagement activities (including those of the...Compliance and Legal to ensure all engagement strategies meet regulatory and ethical standards. **Cross-Functional Collaboration** + Work close… more
- Otsuka America Pharmaceutical Inc. (Dover, DE)
- …product strategy and scientific messaging. + Collaborate cross-functionally with Medical Affairs , Regulatory , Legal, and Commercial teams to ensure consistency ... The Manager , Medical Core Content is a team-level operational...Act as key support resource for the Field Medical Affairs team, managing the content repository and version control… more
- Edwards Lifesciences (Dover, DE)
- …Provide medical writing expertise and collaborate with cross functional teams including Regulatory Affairs , Biostatistics, R&D, QA and Marketing on clinical data ... and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to… more
- Otsuka America Pharmaceutical Inc. (Dover, DE)
- …issues, protocol deviations, and potential noncompliance. + Collaborate with Clinical Operations, Regulatory Affairs , and Medical Affairs to embed quality ... **Job Summary** The Senior Manager of Global Quality Management (GQM) supports the...activities to ensure compliance with Good Clinical Practice (GCP), regulatory requirements, and internal standards across global clinical trials.… more
- Sumitomo Pharma (Dover, DE)
- …benefit-risk assessment. * Collaborate with colleagues in Clinical Development, Regulatory Affairs , Biostatistics, Data Management, and other departments. ... website https://www.us.sumitomo-pharma.com or follow us on LinkedIn. The Senior Manager , Pharmacovigilance Scientist serves as the primary Pharmacovigilance and Risk… more
- Otsuka America Pharmaceutical Inc. (Dover, DE)
- …or similar. + Certification in DEA compliance, Quality Assurance, or Regulatory Affairs . **Competencies** **Accountability for Results -** Stay focused ... The Manager , Global Product Quality - Controlled Substances is...meet Good Manufacturing Practices (GMP) and comply with global regulatory requirements, including DEA regulations. This role partners closely… more
- Sumitomo Pharma (Dover, DE)
- …us on LinkedIn. We are seeking a highly skilled and collaborative **Senior Manager , Web Development** to lead the design, development, and support of our company's ... This includes websites supporting Marketing, Corporate Communications, and Medical Affairs . The ideal candidate combines front-end development expertise with… more
- Otsuka America Pharmaceutical Inc. (Dover, DE)
- …actions (CAPAs). + **Stakeholder Engagement** : Collaborate with Clinical Operations, Regulatory Affairs , Pharmacovigilance, and other functions to ensure ... The **Global Quality Audit Manager ** is responsible for planning, executing, and reporting...data and ensuring patient safety by verifying adherence to regulatory requirements and internal standards. As a key member… more
- Newell Brands (Dover, DE)
- …a related field. + 3-5 years of experience in tax incentives, government programs, regulatory affairs , or a related area (internships or co-op experience may be ... and collaborative environment where you can be your best, every day. The Associate Manager , Tax Incentives & Grants will support the Manager in identifying,… more
- Sumitomo Pharma (Dover, DE)
- …but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs , Data Management and Biostatistics is essential. ... as required. + Coordinate responses to ad hoc safety issues such as regulatory authority, site, or health care professional requests, along with PV physician,… more
- Edwards Lifesciences (Dover, DE)
- …and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to ... with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize… more
- Otsuka America Pharmaceutical Inc. (Dover, DE)
- …**Global Collaboration & Stakeholder Engagement** + Partner with stakeholders across Regulatory Affairs , Clinical, Manufacturing, Compliance, and IT to align ... The Senior Manager , Centers of Excellence (CoEs) is responsible for...roles. + Solid understanding of GxP principles and global regulatory expectations. + Experience supporting audit or inspection readiness… more
- Sumitomo Pharma (Dover, DE)
- …a dynamic, highly motivated, experienced individual for the position of **Senior Manager , Meetings and Events** that will function as primary liaison for internal ... associated with the meeting + Collaborates with Marketing, Sales, and Medical Affairs to define exhibit and convention objectives. Serves as liaison with third-party… more
- Oracle (Dover, DE)
- …deep understanding of market trends, customer requirements, competitive landscape, and regulatory changes impacting the higher education sector. + Gather and analyze ... customers, prospects, and partners, with emphasis on registrar's office, academic affairs , and enrollment operations. + Support creation and prioritization of… more