Regulatory Affairs Associate Consultant Plm Jobs

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

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. 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 Gilead and help create possible, together. Job Description Regulatory Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams. RA Ad/Promo provides strategic regulatory guidance and input on Gilead's commercial and corporate communications, and plays a critical role ensuring that these activities are compliant with governing laws, regulations, and Gilead policies and procedures, while enabling the business to compliantly meet its goals and objectives. This group also represents Gilead's commercial activities to U.S. regulatory agencies. You will manage the commercial regulatory strategy and execution of such for multip

Who we are About Stripe Stripe is a financial infrastructure platform for businesses. Millions of companies—from the world's largest enterprises to the most ambitious startups—use Stripe to accept payments, grow their revenue, and accelerate new business opportunities. Our mission is to increase the GDP of the internet, and we have a staggering amount of work ahead. That means you have an unprecedented opportunity to put the global economy within everyone's reach while doing the most important work of your career. About the team We started operations in the UAE in 2021 as our first Middle East launch to provide UAE businesses of all sizes with the financial infrastructure they need to accept payments, manage operations, and grow their revenue globally. The EMEA Regulatory Legal team is a team of legal counsel responsible for providing strategic guidance on Stripe's financial regulatory obligations across EMEA. We're hiring our first team member based in the UAE to lead our work in the UAE and future expansion in the region. As a member of the team, you'll tackle a diverse range of cutting-edge financial regulatory challenges on a daily basis. You'll have the chance to influence new product development, interact with regulatory authorities shaping our industry, and help define Stripe's policy positions. What you'll do We're seeking an experienced legal counsel with a passion for payments and fintech regulation. In this role, you'll be a trusted advisor to our business, legal, policy, compliance, and risk partners on applicable regulations. You'll also work with internal stakeholders to engage regulators and policymakers on these issues to enable Stripe's mission of helping businesses to grow and thrive. You'll have the opportunity to contribute more broadly to other regulatory and legal matters as well. This is a full-time role for a candidate based in the UAE (based in-office) and will report to the Head of EMEA Regulatory Legal, based in Dublin. Responsibilities •

This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride. Your Role at Baxter Baxter is seeking an experienced leader to oversee Product Stewardship and the execution of environmental and social product-related regulatory programs across the enterprise. This role is responsible for monitoring emerging regulations, assessing business applicability, establishing implementation roadmaps, and driving cross-functional execution to ensure compliance across Baxter's global portfolio. The leader will work closely with business segments, drive collaboration with other functions such as R&D, Regulatory Affairs, Quality, and Legal, and Operations teams to translate evolving requirements into practical and timely actions. Success in this role requires exceptional program management, organizational leadership, and execution capabilities. The individual must be skilled at coordinating complex initiatives across multiple stakeholders, driving accountability, and ensuring that Baxter remains ahead of regulatory requirements while proactively identifying opportunities to develop products and solutions that

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice is searching for a Labeling Artwork Controller - Consultant in Czech Republic for 12 months Contract with REMOTE option with possibility of extension to join one of our consumer product clients. Role Summary The Regional / Senior Artwork Controller is responsible for managing the end-to-end artwork development process (brief → final release) for packaging and labeling components within the region. This role ensures timely delivery of high-quality, compliant artwork by coordinating cross-functional teams and external vendors, while driving process improvements and maintaining operational excellence. This role combines hands-on execution with team supervision. Key Responsibilities: Manage the end-to-end artwork development process from initiation through approval and release, ensuring timely delivery of high-quality labeling components. Act as the primary liaison between PMO, Regulatory Affairs, Marketing, Packaging, Quality, Supply Chain, and external vendors/agencies. Validate briefs for accuracy and completeness; collaborate with cross-functional teams to resolve discrepancies. Oversee timelines, resource planning, and progress tracking for multiple concurrent labeling projects. Coordinate review and approval of labeling content and artwork in internal systems, ensuring compliance with regulatory, legal, and corporate standards. Drive process improvements related to artwork development, approval workflows, and digital tools. Investigate Root Cause Analyses (RCAs) and implement Corrective and Preventive Actions (CAPA) as needed. Maintain artwork issue logs and attend escalation meetings to provide updates. Identify inefficiencies and escalate to Hub Leads when required. Participate in content lock

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice is searching for a Labeling Artwork Controller - Consultant in Italy for 12 months Contract with REMOTE option with possibility of extension to join one of our consumer product clients. Role Summary The Regional / Senior Artwork Controller is responsible for managing the end-to-end artwork development process (brief → final release) for packaging and labeling components within the region. This role ensures timely delivery of high-quality, compliant artwork by coordinating cross-functional teams and external vendors, while driving process improvements and maintaining operational excellence. This role combines hands-on execution with team supervision. Key Responsibilities: Manage the end-to-end artwork development process from initiation through approval and release, ensuring timely delivery of high-quality labeling components. Act as the primary liaison between PMO, Regulatory Affairs, Marketing, Packaging, Quality, Supply Chain, and external vendors/agencies. Validate briefs for accuracy and completeness; collaborate with cross-functional teams to resolve discrepancies. Oversee timelines, resource planning, and progress tracking for multiple concurrent labeling projects. Coordinate review and approval of labeling content and artwork in internal systems, ensuring compliance with regulatory, legal, and corporate standards. Drive process improvements related to artwork development, approval workflows, and digital tools. Investigate Root Cause Analyses (RCAs) and implement Corrective and Preventive Actions (CAPA) as needed. Maintain artwork issue logs and attend escalation meetings to provide updates. Identify inefficiencies and escalate to Hub Leads when required. Participate in content lock meetings

About Us OpenFX is on a mission to move money as freely as data, unrestricted by time zones, banking hours, or legacy systems. We are building the infrastructure that will power the next generation of cross-border payment systems for institutions. The team's execution has been exceptional, and we're scaling at a remarkable pace. Our stellar early team comes with experience in companies like J.P. Morgan, Goldman Sachs, FalconX, Paypal, Affirm, Polygon, Kraken, Nium & others. We’re backed by Accel, Lightspeed, NfX and other top-tier investors. Role Overview We're seeking an exceptional Americas Legal Counsel to serve as a strategic partner and legal advisor across our business, with a particular focus on financial products and partnerships. This role combines the intellectual challenge of navigating cutting-edge financial technology with the opportunity to shape legal strategy in the early stages at a high-growth company. You'll work on some of the most complex and interesting problems at the intersection of cross-border payments, cryptocurrency, foreign exchange and technology—providing pragmatic, business-oriented counsel that enables rapid growth while managing risk effectively. The ideal candidate is a team player who is energized by a high-growth environment and translating complex legal requirements and legal ambiguity into clear, actionable strategies. You move quickly with sound judgment, and excel as a trusted senior advisor to product, engineering, compliance, and business teams. Key Responsibilities: Product Legal Advise product and engineering teams on the legal and regulatory aspects of product design, development, and launch, with a particular focus on payment and banking products Translate complex regulatory requirements into clear guidance that helps teams build compliant products while growing rapidly Regulatory & Licensing Strategy Partner closely with business teams and compliance to develop and execute licensing and market entry strategies

We take play seriously. We’re looking for curious adventurers ready to find their party, fueled by imagination and drive to build what’s never been built before. At Hasbro and Wizards of the Coast, you’ll collaborate with passionate teams to reimagine our iconic brands and create experiences that spark joy, connection, and community through the magic of play. This is your chance to shape legendary play that lasts a lifetime. At Hasbro, play is at the heart of everything we do, and so is making sure that play is safe. We are looking for an experienced quality, regulatory and compliance leader to head our EMEA team, driving product safety and technical compliance across Hasbro and licensed product. You will lead a specialist QA team, act as Hasbro's technical voice in the industry bodies that shape toy regulation, and partner with global stakeholders to ensure our products meet the highest safety standards in every market they reach. You will join a global QA team that is every bit as passionate about safety as we are about having fun. If you want to make a measurable impact on an iconic brand portfolio, we would like to hear from you. Key Responsibilities Represent Hasbro in industry and standardization bodies including TIE, TA, ATPA, BTHA, FJP, AFNOR, CEN and ISO, shaping proportionate regulation and standards for the company and the wider toy industry. Lead and develop the EMEA QA team, setting technical direction and providing authoritative interpretation of regulatory and licensing requirements. Monitor regulatory change across EMEA, assess business exposure, and lead engagement with industry associations to mitigate impact. Own the Regulatory Change Management Process for the region, ensuring new requirements are implemented on time and verified. Develop compliance strategies for complex markets, notably distributor territories and the GCC region including Saudi Arabia, and equip local teams

ABOUT THE ROLE The Product Safety and Compliance Engineer supports Peloton's global Technical Product Safety and Regulatory Compliance organization by ensuring components and finished connected fitness equipment sourced from Taiwan and China meet Peloton's safety, quality, and regulatory standards. Based in Taichung, Taiwan, this position serves as Peloton's on-the-ground technical resource for its Asia-based supply chain, requiring up to 30% travel. This role works cross-functionally with Product, Design, Engineering, Global Quality, Legal, and Regulatory Affairs teams to ensure all products are safe, legally compliant, and certification-ready for global markets.This position places a strong emphasis on scalable processes, proactive pre-certification testing, root-cause analysis, and preventive action. Using structured methodologies such as 8D, the Engineer is expected to lead compliance strategies during product development and sustaining activities, resolve the underlying causes of supplier safety issues, and prevent recurrence, rather than applying reactive, short-term fixes. The engineer will also help drive initiatives that elevate product safety beyond baseline regulations throughout the entire product lifecycle. YOUR DAILY IMPACT AT PELOTON Partner with cross-functional teams to manage day-to-day safety and regulatory compliance activities with component suppliers and OEM/ODM manufacturers in Taiwan and China Drive the creation, scoping, scheduling, and execution of test and global certification plans (UL/CSA, CB Scheme, CCC, BSMI/CNS, PSE, CE, FCC/NCC, IC, and EN EMC) Develop pre-certification test strategies to proactively identify, debug, and resolve compliance and safety risks early in the development cycle Review and analyze lab/supplier test reports, certificates of compliance, and technical files for accuracy, completeness, and conformance to international standards Lead root-cause analysis and corrective/preventive action (CAPA) using structured

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. <

Job Title: Assistant – Operations Employment Type: Contract (12 months) Location: Bengaluru, India Work Type: Office-based Experience: 1–1.5 years About ClinChoice ClinChoice is a partner to the largest pharmaceutical, medical device, and consumer care innovators in the world. Established in 1995, we provide expertise in clinical operations, biometrics, regulatory affairs, pharmacovigilance, medical affairs, and toxicology to help our partners advance healthcare by accelerating clinical trials with data-driven insights, delivering the best strategies for product registration, and enhancing patient safety through real-world and clinical analysis. Our global delivery network has expanded to centers and satellite offices in the United States, Mexico, the United Kingdom, Armenia, China, Japan, India, and the Philippines to help our customers maintain regulatory compliance locally and globally. We have forged future-defining partnerships with industry bodies and technology companies to develop cutting-edge solutions that deliver our expertise with quality and precision. Primary Responsibilities • Biometric & Access Management: Manage biometric attendance systems and employee access control. Activate access for new joiners and deactivate access for exiting employees. Coordinate maintenance and troubleshooting of biometric devices. Maintain and update biometric and access trackers. • CCTV Monitoring & Maintenance: Monitor CCTV systems and ensure proper functioning. Maintain CCTV time synchronization and recording accuracy. Coordinate with vendors/service providers for maintenance and issue resolution. • Security & Housekeeping Coordination: Supervise security and housekeeping operations. Manage attendance and manpower allocation for security/HK staff. Ensure workplace cleanliness, safety, and operation

Job Description Job Title: Medical Reviewer Employment Type: Contract Location: Brazil Experience – 2 to 5 Years About ClinChoice ClinChoice is a partner to the largest pharmaceutical, medical device, and consumer care innovators in the world. Established in 1995, we provide expertise in clinical operations, biometrics, regulatory affairs, pharmacovigilance, medical affairs, and toxicology to help our partners advance healthcare by accelerating clinical trials with data-driven insights, delivering the best strategies for product registration, and enhancing patient safety through real-world and clinical analysis. Our global delivery network has expanded to centres and satellite offices in the United States, Mexico, United Kingdom, Armenia, China, Japan, India, and the Philippines to help our customers maintain regulatory compliance locally and globally. We have forged future-defining partnerships with industry bodies and technology companies to develop cutting-edge solutions that deliver our expertise with quality and precision. Primary Responsibilities: Awareness and understanding of relevant GVP modules. Perform medical review of non-serious & serious ICSRs with emphasis on seriousness, expectedness, causality & narrative etc. without missing on quality & compliance. Experience of medical review of ICSRs received from sources such as Spontaneous, Literature, Regulatory Authority, Solicited and Clinical trials. Experience across multiple therapeutic areas such as Oncology, Respiratory, Immunology, Neuroscience, Rare diseases etc. Support triage of cases and determine seriousness and relatedness across products as assigned. Review and verify appropriate selection of adverse events from source documents, assign appropriate MedDRA code, assess labelling and review narrative. Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas. Involve in process improvement

Job Title: Lead - Aggregate Reporting Employment Type: Full-time Work Type: Remote About ClinChoice: ClinChoice is a partner to the largest pharmaceutical, medical device, and consumer care innovators in the world. Established in 1995, we provide expertise in clinical operations, biometrics, regulatory affairs, pharmacovigilance, medical affairs, and toxicology to help our partners advance healthcare by accelerating clinical trials with data-driven insights, delivering the best strategies for product registration, and enhancing patient safety through real-world and clinical analysis. Our global delivery network has expanded to centers and satellite offices in the United States, Mexico, the United Kingdom, Armenia, China, Japan, India, and the Philippines to help our customers maintain regulatory compliance locally and globally. We have forged future-defining partnerships with industry bodies and technology companies to develop cutting-edge solutions that deliver our expertise with quality and precision. Primary Responsibilities: Responsible for authoring Aggregate Safety Reports (including but not limited to PBRER/PSUR, ACO, DSUR, PADER, CAR, RMP, Ad-hoc safety reports for medicinal and non-medicinal products and EU-MDR PSUR, PMSR, PMSP, and PRER reports for medical devices, and Cosmetovigilance reports for Cosmetic products for submissions to various health authorities as per the requirement). Plan report-specific timelines, identify relevant stakeholders, request calls for contributions, and coordinate with various stakeholders for obtaining relevant data for the preparation of aggregate safety reports. Review the safety data (including the seriousness and expectedness assessments of events, as may be necessary) as per the agreed strategy and sponsor’s conventions and verify the correctness and completeness of contributions received from stakeholders. Perform aggregate review of post-marketing cases received in global databases and assess whether the cases alter t

Work Flexibility: Hybrid What You Will Do / Roles & Responsibilities As a member of the Global Product Engineering team you will gain in depth knowledge about Stryker’s Trauma & Extremities portfolio. You will learn how Bone Plates & Screws, External Fixators, Surgical Instruments and many other products improve people’s life. Together we are responsible for over 50'000 articles. We count on you to maintain and improve our high standard in design specification and performance. You ensure compliance with applicable regulatory and quality requirements, including FDA, EU MDR, ISO 13485, and internal standards, by driving design change management activities, support regulatory submissions, and serving as a subject matter expert during internal and external audits. In your field of responsibility, you will make sure that design requirements are met as well as apply the design change process and identify technical solutions in this context. You oversee the continuous improvement projects for existing products in our group, create and manage project plans, assign and follow up on work packages. You participate in and at times lead cross functional teams to perform design related Non-Conformities(NC), Corrective- and Preventive-Actions(CAPA). Your role will include frequent contact with other teams such as the international Regulatory Affairs, Tech. Publications, Design Quality or Marketing to address design related questions for international registrations and creations of technical files required for the implementation of EU-MDR requirements. Drive value improvement, design optimization, and continuous improvement initiatives to enhance product performance, quality, compliance, and cost effectiveness. What You Need <

Job Title Site Leader (Director), Operations Quality Assurance- Job Description The Site Leader (Director), Operations Quality Assurance is responsible for leading the Quality function across the Pune (Chakan) manufacturing sites. This role provides strategic and operational leadership to ensure all medical devices, manufacturing processes, and quality system activities comply with applicable regulatory requirements, Philips standards, and business objectives. Your Role: Lead all Operations Quality Assurance activities across the Pune (Chakan) manufacturing sites, ensuring compliance, product quality, patient safety, and operations quality performance. Accountable for developing and executing the Operations Quality Strategy, translating enterprise quality objectives into measurable site-level priorities/results, driving a culture of quality and compliance, ensuring inspection readiness, and continuously improving quality performance across the sites. As the senior Quality leader and designated Quality Management Representative, the Director represents the organization during regulatory inspections/external audits, ensures the effectiveness and compliance of the Quality Management System and partners closely with Operations, R&D, Regulatory Affairs, Supply Chain, and Business Leadership to ensure product quality, patient safety, and business continuity. Ensure all products, manufacturing processes, and quality system activities comply with FDA regulations, ISO 13485, ISO 14971, MDSAP, EU MDR, and other applicable global requirements. Lead and represent the sites during FDA inspections, Notified Body audits, customer audits, and regulatory authority interactions, maintaining a continuous state of inspection readiness. Drive timely resolution of audit findings, compliance gaps, nonconformances, and CAPA act