- Ascendis Pharma (Palo Alto, CA)
- …a dynamic workplace for employees to grow and develop their skills. The Director, Regulatory Affairs will be responsible for developing and implementing global ... and regulatory colleagues. + Contributes to the development of global clinical regulatory plans and strategies, identifies, and proposes risk mitigation… more
- J&J Family of Companies (Santa Clara, CA)
- …and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory ... Description:** Johnson & Johnson is hiring for a **Senior Regulatory Affairs Specialist (Remote) - Shockwave** to...process to ensure submission approvals + Evaluate proposed design, clinical and manufacturing changes for regulatory impact… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …position to act as a team member in the product manager area of Regulatory Affairs (Biopharma) supporting global submissions for various areas of the business. ... Specialist I_** **Primary responsibilities for role:** + Act as Regulatory Affairs representative for specified key products/facilities/equipment. + Prepare… more
- Merck (Rahway, NJ)
- **Job Description** At the heart of innovation, our Regulatory Affairs team plays a vital role in delivering new medical advancements to patients around the ... regulatory strategy and submissions through collaboration with Regulatory Affairs Europe (RAE) and local affiliate...content review and approval for IND/CSA submissions to enable clinical trial initiation. + Participate in regulatory … more
- Abbott (Santa Clara, CA)
- …business units that Leveraged Services team supports. **The Opportunity** The **Senior Manager Regulatory Affairs ** will work for our Global Regulatory ... for Devices and Radiological Health (CDRH). This Senior Manager Regulatory Affairs may analyze broad scope implications... and related teams. + Evaluate risk of and regulatory solutions to product and clinical safety… more
- GE HealthCare (Madison, WI)
- …neurology, hemodynamic, and pulse oximetry. You will work within a team of Regulatory Affairs professionals to ensure GE HealthCare establishes best practices in ... compliance with regulatory requirements. The Senior Regulatory ...guide regulatory submission pathways, taking into consideration regulatory requirements (including product testing, clinical data,… more
- J&J Family of Companies (Horsham, PA)
- …Medicine R&D is recruiting for a Director, CMC (Chemistry, Manufacturing and Controls) Regulatory Affairs Biologics New Modalities. This position is a hybrid ... in Horsham, PA; Spring House, PA; Titusville, NJ; or Raritan, NJ. The Director, CMC Regulatory Affairs Biologics New Modalities will lead a team of CMC … more
- Ascendis Pharma (Princeton, NJ)
- …to working together as one team to achieve extraordinary results. The Senior Manager Regulatory Affairs , Advertising and Promotion will be an internal expert on ... the promotion of prescription drug and biologic products. The Senior Manager Regulatory Affairs , Advertising and Promotion is responsible for providing… more
- Philips (Plymouth, MN)
- As a critical member of the Philips Ultrasound- Regulatory Affairs Organization, the Principal Regulatory Affairs Specialist will lead and provide ... to ensure an effective Quality System is maintained. Providing regulatory support for (pre-) clinical studies, including...if:** + You have a minimum of 8+ years' Regulatory Affairs experience within FDA regulated Medical… more
- West Pharmaceutical Services (Exton, PA)
- Sr. Specialist, Regulatory Affairs , Product Stewardship Requisition ID: 69466 Date: Aug 9, 2025 Location: Exton, Pennsylvania, US Department: Regulatory ... and planet through our sustainability efforts. **Job Summary** The Sr. Specialist, Regulatory Affairs evaluates supplier regulatory declarations for… more