- Gilead Sciences, Inc. (Foster City, CA)
- …relevant experience. + BA/BS with 10+ years' relevant experience. + Significant regulatory , quality, compliance or related experience in the biopharma industry. ... create possible, together. **Job Description** You will act as the Regional Regulatory Lead on more complex or multiple products, compounds, indications or projects… more
- Centene Corporation (Olympia, WA)
- …+ Oversee, administer, and implement various aspects of the Medicaid Regulatory Operations/ Compliance program, including communication to/from the Medicaid ... Request for Information/Response + Provide guidance to various departments regarding regulatory issues and ensure implementation of new compliance requirements… more
- Citigroup (New York, NY)
- …works to make sure a robust framework exists to manage and mitigate operational, compliance and regulatory risks across the business to enable the business to ... goal is to provide our clients with a superior client experience and innovative product and solution sets that maximize Citi's penetration of payment flows. Citi is… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- … Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This ... and EU and US Documentation: Independently manages, prepares and implements regulatory documents (eg, USPI, annotated labeling, medication guides, EU SmPC, PIL,… more
- Lilly (Indianapolis, IN)
- …drug substance, drug product , device assembly, and packaging. + Experience in Regulatory Compliance for Product Disposition (RegCOR), for meeting all ... to make life better for people around the world. **Responsibilities** The Senior Director , Global Process Owner for Product Disposition, as a leader within… more
- Mastercard (New York, NY)
- …and subsequent product change. MTS Product line SME, working with the Regulatory , Legal, Compliance and product lines teams to understand and remain ... businesses and governments realize their greatest potential._ **Title and Summary** Product Director , Mastercard Transaction Services - Digital/Crypto focus… more
- Boehringer Ingelheim (Ridgefield, CT)
- …We realize that our strength and competitive advantage lie with our people. The Associate Director , US Product CMC Regulatory Affairs is responsible for the ... regulatory activities required of an IND/NDA/BLA Holder for compliance to FDA requirements for BI's investigational and US...post marketing reports per US FDA regulations. The Associate Director , US Product CMC Regulatory … more
- Bristol Myers Squibb (Seattle, WA)
- …personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Executive Director , Cell Therapy Global Product Quality (CTGPQ) is ... + Ensures adequate resources to serve as single points of contact for product -related changes, and Regulatory CMC liaisons responsible for coordinating reviews… more
- Teleflex (Wyomissing, PA)
- …and working knowledge of ISO9000, FDA and GMP requirements. Innovation, Quality & Regulatory Compliance * Innovation & Continuous Improvement o Foster a culture ... Director , Product Design **Date:** May 22,...and integrate improvements into future processes. * Quality & Regulatory Requirements o Ensure product designs comply… more
- Merck (Boston, MA)
- **Job Description** The Executive Director (Distinguished Scientist) has primary responsibility for the planning and directing of clinical research activities ... Atherosclerosis section of the Atherosclerosis & Metabolism therapeutic area. The Executive Director will manage and oversee the entire cycle of late stage clinical… more