- Sanofi Group (Swiftwater, PA)
- …development and marketed product objectives. + Represent GRA CMC on GRAT ( Global Regulatory Affairs Team) + Assures effective involvement with change ... The team responsibilities include but are not limited to: global regulatory CMC strategies, submission...team creates and maintains strong collaborative working relationships with Global Regulatory Affairs (GRA), Regional… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- Provide CMC regulatory strategy input and expertise in the area of investigational, new and marketed biologic and small molecule drug products to assigned ... teams, to ensure Otsuka's products are developed/maintained in compliance with global regulatory requirements and guidances. Primary regions/markets of… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution...experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical… more
- Teva Pharmaceuticals (West Chester, PA)
- *Manager, Regulatory Affairs Date: May 5, 2025 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva Pharmaceuticals Job Id: 61795 **Who we ... spend your day** Teva Pharmaceuticals USA Inc. seeks a Regulatory Affairs Manager in our West Chester,...Authority Applications (directly or indirectly) + Authoring and Reviewing CMC content for use in Health Authority Applications +… more
- Merck (North Wales, PA)
- …No **Hazardous Material(s):** n/a **Required Skills:** Cross-Functional Teamwork, Global Regulatory Submissions, Management Process, People Leadership, ... Regulatory Data + Direct and Indirect(eg, partnering with CMC , Labeling, etc) execution activities that support Data-based Submissions...Product Lifecycle, Regulatory Affairs Compliance, Regulatory … more
- Sumitomo Pharma (Harrisburg, PA)
- …to clinical supplies on multiple clinical programs. In addition, working closely with CMC , Regulatory Affairs , Quality Assurance, Clinical Operations, and ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...and/or local regulations. + Collaborate closely with Clinical Operations, CMC , Regulatory Affairs , QA, and… more
- Organon & Co. (Plymouth Meeting, PA)
- …colleagues in preclinical science, data science, clinical operations, regulatory affairs , chemistry, manufacturing and control ( CMC ), project management and ... are sound, based on the most up-to-date literature and regulatory guidance and support the approved early development plans....live their best lives. We are a $6.5 billion global healthcare company focused on making a world of… more