- Aequor (Thousand Oaks, CA)
- Regulatory Affairs Associate - CW Remote EST preferred. Ideal candidate: BS &plus 4YOE or MS and around 2 YOE. Preferred or pharma experience. Veeva PromoMats ... process documents. Description: Administrative projects as backup support of Operations staff during project period. Assist US Promotion Regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team ... point of contact for cross-functional teams on RA labeling issues. Collaborate with Regulatory Affairs and Labeling colleagues in other regions, including Japan,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing with both internal ... Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams to deliver and drive...support of the development objectives for DCR-PHXC and assist Regulatory Strategy staff in the compilation of… more
- Merck & Co. (South San Francisco, CA)
- …(including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials operations).Provide ... Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs , and late-stage Clinical Research throughout… more
- Merck & Co. (Boston, MA)
- …scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials operations) for ... populationsProviding early phase/clinical pharmacology support for programs through the regulatory filing process including preparation of supportive documents and… more
- Novo Nordisk Inc. (Milwaukee, WI)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Hub. Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs , Data Management, Biostatistics, Non-clinical, Medical ... functional teams. Oversees daily operations of the function by directing staff and adhering to company-wide policies, procedures and programs. Manages organizational… more
- BD (Becton, Dickinson and Company) (Sparks, MD)
- …Reporting to the Senior Manager, Regulatory Affairs , Microbiology, the Staff Regulatory Affairs Specialist is responsible for the preparation of ... and regulatory interpretations to Core Teams and to functional staff to achieve rapid worldwide clearance/approval/registrations of products with desired claims… more
- Stryker (San Jose, CA)
- …We are currently seeking a **Senior Staff Regulatory Affairs ... to drive continuous improvement in functions. **What you will do** As the **Senior Staff Regulatory Affairs Specialist** , you will play an integral role on… more
- BD (Becton, Dickinson and Company) (Sparks, MD)
- **Job Description Summary** The Staff Regulatory Affairs Specialist is responsible and accountable for developing and executing sound strategies for ... projects and functional teams with limited oversight, provides instruction, guidance, and regulatory interpretations to functional staff and Core Teams to… more
- Regeneron Pharmaceuticals (Troy, NY)
- …for assigned cell and gene therapy portfolios. This role includes overseeing regulatory affairs staff , various outside contractors, supporting project ... typical day might include:** + Direct activities of assigned Regulatory Affairs team with emphasis on global...+ Experience in dealings with FDA, EMA or other regulatory authorities + Experience managing and developing staff… more
- Takeda Pharmaceuticals (Boston, MA)
- …organization. + Responsible for timely dissemination of regulations, guidelines, and data to Global Regulatory Affairs staff via team sites or intranet. + ... Operations at Takeda will be responsible for formulating and implementing the Global Regulatory Affairs Operations (GRA-Ops) vision and strategy to achieve a… more
- Emory Healthcare/Emory University (Atlanta, GA)
- …in cell therapy studies, such as physicians, translational researchers, research coordinators, regulatory affairs staff , quality control and quality ... patient files and QA/QC program. + Assists with the training of new staff . + Assures that activities are following all compliance requirements including preparation… more
- Fresenius Medical Center (Waltham, MA)
- …May be responsible for the direct supervision of various levels of Regulatory Affairs Operations staff . **EDUCATION:** Bachelor's Degree required; ... Manages the transition from legacy to electronic submissions. + Coordinates with regulatory staff to compile regulatory submissions. + Ensures that all… more
- University of Pennsylvania (Philadelphia, PA)
- …of health and wellness programs and resources, and much more. Posted Job Title Regulatory Affairs Specialist C Job Profile Title Clinical Research Regulatory ... Specialist C Job Description Summary The Regulatory Affairs Specialist C functions independently with minimal supervision on...Provide guidance and training to Penn faculty sponsors and staff . Assist OCR Regulatory leadership with metrics… more
- Herbalife (Torrance, CA)
- Director, Global Regulatory Affairs - Corporate Category: Legal Position Type: Regular Full-Time External ID: 14913 Location: Torrance, CA, United States Date ... implementation of strategy for multiple complex projects led by the corporate regulatory affairs team, including process improvement for efficiency gain,… more
- AbbVie (Irvine, CA)
- …Affairs Quality Standards is responsible for the management of a RDQA global Safety, Regulatory Affairs (RA) and Medical Affairs (MA) QA team which ... including but not limited to Pharmacovigilance and Patient Safety, Regulatory Affairs and Medical Affairs ...expectations and goals to ensure organizational success and lead staff to meet or exceed those expectations. Encourage a… more
- University of Colorado (Aurora, CO)
- ** Regulatory Affairs Coordinator (Entry Senior Level)** **Description** **University of Colorado Anschutz Medical Campus** **School of Medicine | Department of ... Medicine | Division of Hematology** **Job Title: Regulatory Affairs Coordinator (Entry - Senior Level)**...meets with representatives from sponsoring pharmaceutical firms or in-house staff for initial orientation to studies and for review… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- **Job Description Summary** The Sr. Director, Regulatory Affairs is the ranking Regulatory Affairs leader for the Infusion Process Excellence RA ... to business partners, the Assoc Director of Process Excellence Regulatory Affairs , and execute regulatory ...emerging opportunities and concerns to stakeholders + Manages a staff of regulatory professionals responsible for product… more
- Amgen (Washington, DC)
- …10 million patients worldwide. It's time for a career you can be proud of. ** Regulatory Affairs Director - Global Regulatory Leader - Oncology** **Live** ... this. Let's change the world. Amgen is seeking a Regulatory Affairs Director supporting products in the...Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to… more
