- Actalent (Lake Forest, CA)
- Description We are seeking an experienced and strategic Regulatory Affairs Manager to support global regulatory submissions and compliance activities. This ... plan, Regulatory compliance, Compliance, Quality engineering, Medical device, Regulatory affairs , CMC, manufacturing controls, RAC certification, e star,… more
- Globus Medical, Inc. (Audubon, PA)
- …can resume their lives as quickly as possible. **Position Summary** **:** The Regulatory Affairs Associate assists in drafting, submitting and gaining clearance ... data with Clinical Data Manager and other Clinical Affairs personnel, as needed for IDE...device industry or equivalent, preferably within orthopedic medical devices; Regulatory Affairs experience is a plus. +… more
- J&J Family of Companies (Spring House, PA)
- …and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory ... candidates from any location to apply. The Director, Global Regulatory Leader in Global Regulatory Affairs...to general regulatory knowledge and provide strategic regulatory input into clinical trial designs, labeling,… more
- Lilly (Indianapolis, IN)
- …for people around the world. **Purpose:** The purpose of the Senior Director Global Regulatory Affairs , Global Regulatory Lead (GRL) role is to develop ... regulatory excellence attributes as described in Global Regulatory Affairs white papers. + Constructively challenge...development experience for 10 years + Direct experience in clinical and CMC regulatory sciences + Experience… more
- Mount Sinai Health System (New York, NY)
- …a health science or legal/ regulatory studies + 3+ years of direct experience in Regulatory Affairs , Clinical Affairs or Quality Assurance within the ... Duties include, but are not limited to, management of clinical studies through the regulatory portion of...and obtains approval from the Food and Drug Administration ( FDA ) for investigator-initiated clinical trials. Acts as… more
- Stanford University (Stanford, CA)
- …including project management in a dynamic research setting. + Strong knowledge of regulatory affairs , including FDA regulations, IRB review and approval ... The Blood & Marrow Transplantation and Cellular Therapy (BMT-CT) Divisionis seeking a Clinical Trials Regulatory Specialist II position to support a very active… more
- Dana-Farber Cancer Institute (Boston, MA)
- …clinical trials start-up, active and close out phases + Proficient knowledge of regulatory affairs , research ethics and the responsible conduct of research + ... unit will provide pan-CTIP support as part of our clinical research infrastructure. CTIP regulatory unit will...regulatory agencies including the Food and Drug Administration ( FDA ), Office of Biotechnology Activities (OBA) + Support the… more
- GE HealthCare (Waukesha, WI)
- …the General Imaging and Primary Care Business. This position bridges engineering, regulatory affairs , and biostatistics, ensuring that validation studies, data ... Regulatory Documentation & Submission** + Write and review regulatory reports (eg, FDA 510k, NMPA) with...statistical rigor and clarity. + Collaborate with engineering and regulatory affairs to ensure alignment with the… more
- CSL Behring (King Of Prussia, PA)
- …successful regulatory outcomes. Effectively partner with assigned product/s Global Regulatory Affairs Strategy Team (GRAST) GRL plus other regional, labeling ... regulatory activities/submissions and 3 years working on developmental products. Previous regulatory affairs experience is preferred. + Experience in working… more
- Takeda Pharmaceuticals (Boston, MA)
- …in regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively ... area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively… more