- CVS Health (Harrisburg, PA)
- …each and every day. **Position Summary** Under general supervision the Senior Document Writer drafts, reviews, and edits medical, dental and vision plan documents. ... This position will support plan document needs for new business by creating plan documents...with benefit terminology. + General understanding of compliance and regulatory issues (ERISA, HIPAA, ACA, COBRA). + Organizes time… more
- Globus Medical, Inc. (Audubon, PA)
- …documentation that is required by Globus Medical, Inc. and other regulatory agencies. This will include issuing, maintaining, controlling, and auditing documentation ... development, release, and maintenance phases of product realization + Processes Document Change Orders (DCOs) to implement all controlled documentation and maintain… more
- Dairy Farmers of America (Hummelstown, PA)
- …trend, and analyze test results to enable proactive decision making. + Support customer, regulatory and 3 rd party Quality and Food Safety audits. + Facilitate the ... + Act as back-up for QA Manager in his/her absence + Execute essential document review and approval (PC and HACCP documentation) + Investigate, find solutions, and… more
- Merck (Harrisburg, PA)
- …Experience and Skills** + Experience implementing or supporting automated regulatory authoring (structured content, template-driven generation, or document ... and supply. A key workstream within this initiative is the auto-generation of regulatory filing sections, enabled by a dedicated application designed to create a… more
- Sanofi Group (Swiftwater, PA)
- …Clinical Development is an asset. **Skills & Capabilities** : + Knowledge of regulatory or other guidelines pertaining to document standards and submission ... the scope of the assigned franchise, prepared in accordance with regulatory specifications and strategic messaging to support the clinical development, marketing… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription ... activities for all assigned projects in alignment with the Global Regulatory Lead. Translates complex pertinent global requirements and provides an assessment… more
- Teva Pharmaceuticals (West Chester, PA)
- …inquiries from regulatory agencies. * Assist in implementation of electronic document management system in the department. * Plan and oversee the compilation of ... Associate Director, Regulatory Affairs Date: Dec 2, 2025 Location: West...a difference with. **The opportunity** The Associate Director, Global Regulatory Affairs, will be responsible for providing regulatory… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- The Associate Director of Regulatory Intelligence leads the collection and dissemination of regulatory intelligence and collaborates with SMEs to interpret the ... impact of regulatory changes to the pharmaceutical environment. **Job Description** +...platform. + Lead internal process to obtain, coordinate, and document cross-functional SME impact assessments of new or updated… more
- West Pharmaceutical Services (Exton, PA)
- Sr. Specialist, Regulatory Affairs, Product Stewardship Requisition ID: 69466 Date: Nov 8, 2025 Location: Exton, Pennsylvania, US Department: Regulatory Affairs ... planet through our sustainability efforts. **Job Summary** The Sr. Specialist, Regulatory Affairs evaluates supplier regulatory declarations for compliance,… more
- Globus Medical, Inc. (Audubon, PA)
- …and subsequent review of submission content as needed. + Reviews and approves Document Change Orders for US Regulatory , including Regulatory Pathway ... as quickly as possible. **Position Summary** **:** The Manager, Regulatory Affairs, is responsible for preparing, filing and gaining...the time. **Essential Functions** **:** + Guides the US Regulatory team in preparing and filing 510(k), IDE, PMA… more