- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …treatment ecosystems. **Job Description** The specific duties assigned to the Executive Director ; Global Clinical Development Program Lead will include ... science, data management, and medical writing. + Understanding of the global regulatory requirements. Demonstrated experience in successful regulatory… more
- Sumitomo Pharma (Harrisburg, PA)
- …project(s) in line with the global registration strategy of the product + Supports the global regulatory lead (GRL) and the CMC regulatory lead ... The Associate Director is part of the Global Regulatory Affairs (GRA) team based in...Lead , manage regional (United States, European and/or ROW) regulatory activities as part of a Global … more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- **Position Summary:** The Executive Director , Global Value Evidence Lead , is a strategic leader responsible for driving the global value evidence ... market access, and reimbursement across geographies. The incumbent will lead a team of value evidence asset leads and...academic institutions, and industry consortia. + Ensure compliance with global regulatory and ethical standards in evidence… more
- Teva Pharmaceuticals (West Chester, PA)
- …making a difference, and new people to make a difference with. **The opportunity** The Director , Global Regulatory Affairs, is a strategic role that will be ... Director , Regulatory Affairs Date: Jan 8, 2026 Location:...innovative products. * As a global or regional lead within a global regulatory team,… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …environment. **Job Description** + Oversee the capture, review, and dissemination of global regulatory news, public commenting opportunities, new and updated ... + Build professional network with key stakeholders outside of Global Regulatory Affairs to identify regulatory...assessments of new or updated guidance and regulations. + Lead regulatory public commenting process and posting… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …scientific and clinical resource for cross-functional colleagues including Clinical Development, Global Integrated Evidence & Innovation, Regulatory and ... **Job Summary** The Medical Director , Rare Disease is a critical role responsible...directly to the Rare Disease Medical Business Unit (BU) Lead . **Job Description** **Key Responsibilities Include:** **Medical Strategy &… more
- Lilly (Philadelphia, PA)
- … regulatory strategies for investigational and commercial radiopharmaceutical products. + Lead global CMC regulatory submissions including authoring, ... better for people around the world. **Position Overview:** The Director , CMC Regulatory will leverage CMC technical...knowledge and regulatory science expertise to drive global regulatory CMC strategies for Lilly |… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …post commercialization, with emphasis on the large global clinical trials and regulatory filing activities. The Senior Director , GCD is responsible for all ... and clinical trial implementation and management. + Complete understanding of the global regulatory requirements. + Working knowledge of marketing and… more
- Wolters Kluwer (Philadelphia, PA)
- …landscape, pushing boundaries and redefining expectations for innovation and quality. ** Lead Engineering Excellence:** Oversee a global team of engineers ... As the Director of Product Software Engineering for our Legal & Regulatory US business, you will be at the forefront of shaping the technology vision for a… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …**efficiency, consistency, and continuous improvement** across all regions and product lines. The Director will lead global initiatives to harmonize and ... The Director , Global Product Quality, GMP Processes...efficiency. + GMP Compliance: Ensure all quality processes meet global regulatory requirements (eg, FDA, EMA, PMDA)… more