- Sumitomo Pharma (Sacramento, CA)
- …Interface with regulatory authorities, including the FDA, EMA, and other global agencies, to secure trial approvals and navigate the regulatory landscape. ... clinical study reports, and NDA/MAA filings. + Collaborate with regulatory affairs team to ensure compliance with...data and present findings clearly. + Significant experience with global clinical trials and regulatory process. +… more
- J&J Family of Companies (Irvine, CA)
- …Work with business partners including but not limited to R&D, Clinical Research, Regulatory Affairs, Quality & Compliance , Health Economics & Market Access, and ... from AFIB each year. Biosense Webster, Inc. is the global leader in the science of diagnosing and treating...regulatory and commercial strategy, as well as support product development, pre- and post-approval clinical studies, downstream claims,… more
- BD (Becton, Dickinson and Company) (Brea, CA)
- …This role ensures that all IPD products are designed and manufactured in compliance with applicable industry and regulatory standards and meet customer ... a robust Quality Management System (QMS) aligned with corporate policies and regulatory requirements, supporting both new product development and sustaining… more
- CTG (Woodland, CA)
- …responsible for new product setup, quality project management, and ensuring regulatory compliance for serum products. The position will ensure compliance ... * Support supplier audits as needed * Collaborate with USDA on regulatory compliance , including approvals, import/export compliance , traceability,… more
- BeOne Medicines (San Mateo, CA)
- …preferred. + Pharmaceutical product development experience + Experienced in global regulatory requirements for pharmacovigilance **Travel:** Less than 10% ... Lead the analysis of safety data and author relevant safety sections of global regulatory inquiries and periodic reports including Development Safety Update… more
- J&J Family of Companies (Irvine, CA)
- …with all relevant Clinical R&D partners and cross-functional partners (eg Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Health Economics ... R&D Department to execute and manage company sponsored clinical trials, ensuring compliance with timelines and study milestones, for JNJ MedTech Neurovascular .… more
- Medtronic (Irvine, CA)
- …requirements for business continuity, operations security, cryptography, forensics, regulatory compliance , internal counter-espionage (insider threat detection ... objectives. + Collaborate with teams across various departments, including IT, legal, compliance , and product security, to identify, assess, and mitigate… more
- Corza Medical (Chula Vista, CA)
- …returns. + Ensure timely and accurate fulfillment of customer orders in compliance with quality and regulatory standards, while maintaining service-level ... with global carriers, freight forwarders, and customs partners. Support global distribution and international trade compliance requirements. + Control… more
- Coinbase (Sacramento, CA)
- …security infrastructure and controls to protect critical business assets and meet regulatory compliance requirements * Lead engineering build activities for ... emerging onchain platform - and with it, the future global financial system. To achieve our mission, we're seeking...compliance documentation aligned with industry best practices and regulatory requirements *What we look for in you (ie.… more
- Amgen (Thousand Oaks, CA)
- …area to a range of audiences, including executive leadership, development partners, and global regulatory agencies. This role will include global development ... the Vice President, Global Clinical Development. **Responsibilities** + Serve as the global development leader for a product team with an enterprise mindset… more