- West Pharmaceutical Services (Exton, PA)
- Sr. Specialist, Regulatory Affairs, Product Stewardship Requisition ID: 69466 Date: Sep 7, 2025 Location: Exton, Pennsylvania, US Department: Regulatory ... compliance certifications, and responds to internal and external customer and/or agency regulatory requests. With minimal support , the Sr. Specialist ensures… more
- Cardinal Health (Harrisburg, PA)
- …other functions and teams and delegate and direct non-legal tasks to support regulatory compliance implementation. **_Qualifications_** * Bachelor and JD degrees ... regulatory bodies. **_Job Summary_** The Assistant General Counsel, Regulatory - EHS & Product Sustainability will...and teams and delegate and direct non-legal tasks to support regulatory compliance implementation **_What is expected… more
- Organon & Co. (Plymouth Meeting, PA)
- …business processes and systems. + Provide regulatory leadership as needed to product in- license /due diligence review, product divestment and product ... not limited to: **Responsibilities** + Serve as the CMC Product Lead or support the CMC ...projects and be accountable for the delivery of all regulatory milestones for assigned products through the product… more
- Pfizer (Collegeville, PA)
- …and Pfizer internal and external stakeholders. + Ensures rapid reporting of key project/ product regulatory milestones and/or issues to the GRPL and other ... guidance, and technologies + Experience with systems and electronic technologies that support regulatory activities + Proficiency in Microsoft Office + Excellent… more
- Globus Medical, Inc. (Audubon, PA)
- …of clinical trials applications. **Essential Functions** **:** + Demonstrates global regulatory expertise in product submissions and evaluates changes with ... plans, procedures and regulatory decisions for existing products + Reviews regulatory requirements from other departments for product designs or changes to… more
- Organon & Co. (Plymouth Meeting, PA)
- …+ Lead the Global Regulatory Teams, which coordinates cross-functional regulatory support for development programs and marketed products + Independently ... as well as post-approval products with limited clinical development + Regulatory product and compliance management (coordinates the preparation, submission… more
- Merck (West Point, PA)
- …+ Accelerated timelines for site, filing, and launch readiness + Improved access to product and process data + Streamlined transfer of process and product ... 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
- Merck (North Wales, PA)
- …global point of contact, with significant experience, the Liaison provides strategic regulatory oversight to accelerate approvals and optimize product labeling. ... in IBD strongly preferred. **Primary Responsibilities** + Develop and lead global regulatory strategies to support multiple indications, optimizing labels and… more
- Organon & Co. (Plymouth Meeting, PA)
- …reports, registration renewals, and responses to health authority questions. + Provide regulatory leadership for product in-licensing, due diligence reviews, ... project teams and alliance partners to develop and implement world-wide regulatory strategies for assigned biosimilar projects, with a specific focus on… more
- Organon & Co. (Plymouth Meeting, PA)
- …and the application of emerging technologies (eg, artificial intelligence, machine learning, regulatory cloud) to support global regulatory harmonization and ... **Job Description** **The Position** Leading the Regulatory Policy and Intelligence activities for Global ...Policy and Intelligence insights to the organization to guide product development, and geographical expansion strategies for R&D portfolio… more