- The Hershey Company (Hershey, PA)
- …location is Hershey or east coast with travel to Hershey monthly. * Overview* The Director of Regulatory Affairs for the Americas is responsible to assure ... including but, not limited to auditing and monitoring, and regulatory approval processes. The Director will proactively...issues impactful to the business. 3. Lead the cross-functional Regulatory & Scientific Affairs team to continuously… more
- J&J Family of Companies (Harrisburg, PA)
- …- 2406184564W **Description** Johnson & Johnson Innovative Medicine is recruiting for a Director , Global Regulatory Affairs Leader located in New Jersey ... technology assessments, payor demands) + Lead the preparation of regulatory dossiers for submissions to US FDA....authority regulated industry + At least 6 years of Regulatory Affairs experience required with focus on… more
- Merck (Harrisburg, PA)
- …+ Stay updated on emerging regulations and industry trends affecting device quality and regulatory affairs . Strategic Contributions + Serve as a key member of ... + 10+ years of experience in device quality, device regulatory affairs , or a related field within...in certain states and cities within the United States . Final determinations with respect to… more
- Merck (Harrisburg, PA)
- …Description of Position-** This position will be part of the Device Quality & Regulatory Team within Global Regulatory Affairs and Clinical Safety (GRACS). ... analysis of data for management review. **Reports to** - Director Regulatory Compliance, Device Quality and ...in certain states and cities within the United States . Final determinations with respect to… more
- Takeda Pharmaceuticals (Harrisburg, PA)
- …will inspire you and empower you to shine? Join us as an Associate Director , Global Regulatory Project Management and Strategic Planning - GI2 TAU within our ... Global Regulatory Affairs organization, based remotely. + Partners...MS Project, OnePager, Office Timeline, SharePoint etc). **More about us :** At Takeda, we are transforming patient care through… more
- Takeda Pharmaceuticals (Harrisburg, PA)
- …you to engage in meaningful work? Join us as an _Associate Director - Nonclinical Regulatory Writer_ _and Submission Support_ reporting to the Nonclinical ... FDA/EMA/PMDA regulations; ICH guidance; GLP/GCP requirements; SEND requirements, etc.). + Regulatory Affairs Credential (RAC-Drugs) is an advantage. + Strong… more
- Takeda Pharmaceuticals (Harrisburg, PA)
- …part of the Global Regulatory & Policy Innovation, you will report to Executive Director & US Head, Global Regulatory Policy & Innovation. **How you will ... Policy and Innovation where you will anticipate, assess, and influence US regulatory policy impacting innovative drug development. Create and amplify… more
- Takeda Pharmaceuticals (Harrisburg, PA)
- …+ Working within Labeling Team and GRA + Represents Global Labeling at Global Regulatory Team (GRT) + Liaises with US Labeling Operations, EU Labeling ... of 5+ years regulatory and/or related experience. + Strong knowledge of US and EU product labeling requirements, regulations, and guidelines (USPI and EU SmPC… more
- WellSpan Health (York, PA)
- …as Insurance Specialty Center, Payor Contracting, Compliance, IT, Finance, and Regulatory Affairs to enhance WellSpan Health's utilization management ... Director -Utilization and Denials Management Location: WellSpan Health, York,...processes in accordance with contract compliance as well as regulatory requirements. + Oversees and evaluates the activities and… more
- Terumo Medical Corporation (Elkton, MD)
- …will all applicable regulations and standards including but not limited to US Quality System Regulation, Japanese Pharmaceutical Affairs Laws, ISO 13485, ... Director , Quality Systems & Compliance Date: Nov 1, 2024 Req ID: 3923 Location: Elkton, MD, US Caguas, PR, PR Somerset, NJ, US , 08873 Company: Terumo Medical… more
- Prime Therapeutics (Harrisburg, PA)
- …Medicine, Bachelor of Surgery (MBBS) international degree with successful completion of United States based internship and residency (and successful completion ... requesting physicians or ordering providers, when available, within the regulatory time frame of the request by phone or...of United States based fellowship for subspecialists) required.… more
- Prime Therapeutics (Harrisburg, PA)
- …the Affordable Care Act (ACA) + Must be eligible to work in the United States without need for work visa or residency sponsorship **Additional Qualifications** ... are met and business operations are aligned with applicable laws and regulatory guidance. + Provide consultative leadership and direct efforts to communicate… more
- Army National Guard Units (Gap, PA)
- …or considered for the position. In accordance with section 9902(h) of title 5, United States Code, annuitants reemployed in the Department of Defense shall ... DCSG4 (This includes Combined Support Maintenance Shop - West, Director of Logistics, State Surface Maintenance Office FMS's 2,...retired under section 8336(d)(1) or 8414(b)(1)(A) of title 5 United States Code) appointed to the Department… more
- Edwards Lifesciences (Harrisburg, PA)
- …submission experience + The location for this position can be remote within the United States **What else we look for (Preferred)** **:** + Expert understanding ... 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