Regulatory Affairs Manager – APAC - Diabetes Care (on-site)

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows. Job Description This is an office based/hybrid position. The Manager, Regulatory Affairs CMC is located in El Segundo, CA, Thousand Oaks, CA, Foster City, CA or Parsippany, NJ. Kite is transitioning from its current Santa Monica headquarters, with employees expected to relocate to our Thousand Oaks, CA, El Segundo, CA, Foster City CA or Parsippany, NJ office beginning in January 2027. While this role has the option to be based in Santa Monica through 2026, applicants should take this planned relocation into consideration. Kite supports a flexible working policy, offering a balanced approach with two days of remote working and three days working onsite. Support preparation and submission of CMC regulatory filings (INDs, CTAs, BLAs, MAAs, supplements, and variations), including submissions supporting lentiviral vector (LVV) manufacturing, testing, control strategy, and lifecycl

About the Team OpenAI’s Global Affairs team engages with governments, policymakers, civil society, community organizations, and other stakeholders around the world. The State and Local Government Affairs team leads OpenAI’s engagement with state and local governments across the United States and works cross-functionally to advance policies and partnerships that support OpenAI’s mission. About the Role As Government and Community Affairs Manager, you will help support OpenAI’s engagement with state and local policymakers, community organizations, civic leaders, educational institutions, workforce partners, and other stakeholders across California. Reporting to the State and Local Government Affairs Lead, Western Region, you will develop and maintain relationships with elected officials, agency leaders, legislative staff, local government representatives, and community partners. You will monitor and analyze policy developments, support advocacy and engagement strategies, and help ensure that California stakeholders understand OpenAI’s technology, mission, and approach to responsible AI development. This role extends beyond traditional government affairs. You will also help develop community partnerships, educational initiatives, events, and other programs that demonstrate how AI can benefit people and communities across California. You will work closely with colleagues across Global Affairs, Legal, Communications, Partnerships, Product, Go to Market, and other teams to connect OpenAI’s policy priorities with meaningful external engagement. Although the role will focus primarily on California, you may also support engagement in other Western states on an ad hoc basis. We are looking for someone who is flexible, collaborative, comfortable operating in a fast-moving environment, and able to approach emerging needs with sound judgment and a bias toward action. In this role, you will: Help develop and execute OpenAI’s state and local government affairs and community engage

Work Flexibility: Onsite As the Manager, Quality Assurance , you will lead quality assurance activities that support product quality, process performance, audit readiness, and continuous improvement across site operations. Working closely with Operations, Global Quality, Regulatory Affairs, and supplier partners, you will help ensure quality systems remain effective, compliant, and aligned with business objectives. This role is Onsite in Mahwah, New Jersey . What You Will Do Lead the Quality Assurance team, providing technical guidance and quality oversight across manufacturing and operations, supports functions to drive continuous improvement and compliance. Partner with site leadership to ensure products consistently meet customer expectations, regulatory requirements, and applicable quality standards. Develop, coach, and retain a high-performing team while fostering a culture of inclusion, accountability, collaboration, and employee engagement. Drive quality system compliance by partnering with functional leaders to establish, communicate, and maintain quality standards, requirements, and responsibilities. Lead site readiness activities and support internal, corporate, notified body, FDA, and other regulatory audits and inspections. Oversee the management of nonconforming products, product and process deviations, risk assessments, corrective actions, and preventive actions to ensure effective resolution and compliance. Monitor and improve Quality performance indicators, including NCR, CAPA, compliance, and operational quality metrics, and implement corrective actions for adverse trends. Support the development and execution of local and global Quality Operations strategies that improve product quality, operational efficiency, risk management, and regulatory compliance. <

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows. Job Description Key Responsibilities Manage commercial pharmaceutical labeling projects from initiation through implementation. Coordinate labeling activities across Regulatory Affairs, Quality Assurance, Supply Chain, Manufacturing, Packaging Engineering, and external vendors. Lead artwork development, review, approval, and implementation activities. Manage project timelines, risks, priorities, and deliverables to ensure on-time execution. Review and approve artwork proofs, printer proofs, and packaging components for accuracy and compliance. Maintain labeli

About the Team OpenAI’s Legal team helps advance our mission by tackling novel legal issues in AI. Our team brings together professionals across technology, privacy, intellectual property, corporate, employment, tax, regulatory, and litigation. Our regulatory compliance work turns legal requirements into practical programs that support responsible AI development and deployment. About the Role As a Legal Program Manager focused on regulatory compliance, you will build and manage cross-functional programs that translate counsel’s guidance into practical, sustainable operations. Your initial focus may include content moderation and/or frontier AI governance, with the mix shaped by team priorities and your strengths. You will partner with internal and external counsel, other legal program managers, and technical and business teams to coordinate implementation, evidence collection, reporting, and ongoing compliance. You’ll build repeatable systems that scale across regulations, products, and jurisdictions, helping teams navigate emerging requirements with clarity and sound judgment. This full-time role is based in San Francisco, CA, or New York, NY. In this role, you will: Lead regulatory compliance programs end to end: define scope, owners, milestones, dependencies, risks, and escalation paths, and drive execution with counsel and cross-functional partners. Translate counsel’s regulatory guidance into repeatable workflows, controls, and documentation. Depending on your portfolio, this may include content moderation disclosures, transparency reporting, reporting and appeals workflows, or frontier AI model launch readiness, evaluation and risk-management evidence, and incident reporting. Build strong partnerships across Product, Engineering, User Operations, Governance, Risk and Compliance (GRC), Global Affairs, Communications, and Go-to-Market to align program priorities and deliverables. Support regulatory inquiries, audits and investigations with counsel, organizing ev

Job Title Medical Safety Manager - Ultrasound Job Description Medical Safety Manager, Ultrasound The Medical Safety Manager independently oversees safety surveillance activities for medical products by analyzing data from post-marketing surveillance, literature reviews, and real-world evidence to identify risks and ensure patient well-being. The role supports regulatory compliance through the preparation of safety-related documentation, including Risk-Benefit Analyses, protocols, Clinical Study Reports, and Clinical Evaluation Reports. Your role: Independently conducts comprehensive safety evaluations using data from post-marketing surveillance, literature reviews, and clinical trials to proactively identify and assess potential risks and safety signals. Provides critical safety insights and recommendations for risk management activities, including Health Hazard Evaluations, Risk-Benefit Analyses, and recall procedures, ensuring robust patient safety measures are in place. Supports New Product Introduction, clinical studies, and post-marketing efforts by delivering safety-related perspectives and collaborating on safety inputs for regulatory submissions and key documentation such as RBAs, protocols, Clinical Study Reports, and Clinical Evaluation Reports. Responds to safety-related inquiries from healthcare professionals, patients, and internal stakeholders, fostering trust through transparent communication and supporting the implementation of safety policies, procedures, and programs to promote a culture of compliance. Stays current with evolving medical product safety regulations and guidelines, offering input into the design and execution of safety studies and vigilance activities to ensure adherence to requirements throughout the product lifecycle. You're the right fit if: You’ve acquired 5&#43