Regulatory Affairs Cmc Associate Jobs

Senior Specialist Regulatory Affairs — Irvine, California. Apply via Workday.

What if the work you did every day could impact the lives of people you know? Or all of humanity? At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients. Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible. The Senior Regulatory Affairs Specialist will be an instrumental member of the Regulatory Affairs team supporting on-market in vitro diagnostic (IVD) products in the United States and international markets. This role is responsible for supporting post-market regulatory compliance activities, including adverse event reporting, field actions, recalls, post-market surveillance, and regulatory assessments. The individual will serve as a key regulatory partner to cross-functional teams, providing guidance on regulatory requirements, risk evaluations, and reporting obligations. Key responsibilities include conducting timely assessments of potential adverse events and field actions to determine regulatory reportability, supporting MDR and recall decision-making, coordinating regulatory reporting activities, developing regulatory justifications and documentation, and ensuring compliance with applicable global regulations. The role will also contribute to continuous improvement initiatives through the development and implementation of regulatory procedures, work instructions, and best practices that strengthen post-market c

We are seeking a dynamic professional well versed in the electric utility industry to join our team as Manager, Policy and Regulatory Affairs. The ideal candidate has distributed energy resources (DER) and demand-side management expertise, and experience collaborating with a broad spectrum of industry and government stakeholders. You have the ability to translate EnergyHub's product vision into a set of regulatory and policy objectives with the power to unlock new opportunities across our business units. You are both a big picture and analytical thinker who can turn complex device and DER program data into digestible comments and thought leadership for a diverse audience. You’re motivated to interface with a wide range of stakeholders in the industry and find middle ground amongst utilities, customers, and the distributed energy community. And, you never lose sight of high-priority state, federal, and agency initiatives and proceedings with the potential to impact EnergyHub’s growth. Besides a rock-solid work ethic and a strong team-oriented personality, we’re looking for a candidate that is creative, passionate, and has a desire to break new ground in a constantly shifting landscape. Main Responsibilities The Manager, Policy and Regulatory Affairs, will be an integral part of the Regulatory Affairs team, with the primary responsibilities of accelerating EnergyHub’s growth through legislative, regulatory, and other policy advocacy and providing intelligence to support clients and shape EnergyHub’s long-term business strategy. They will lead EnergyHub’s engagement in public utility commission proceedings and legislative sessions to help scale existing customer programs, and advocate for reforms that ultimately unlock the full value of demand flexibility. The Manager, Policy and Regulatory Affairs will report to the Director of Regulatory Affairs and will collaborate with teams across the company to ensure that our advocacy reflects all that EnergyHub has to offer. Sp

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 •

Noctrix Health is redefining the treatment of chronic neurological disorders with clinically validated therapeutic wearables. Our team of medical device specialists, neuroscientists, and consumer electronics engineers is dedicated to delivering prescription-grade therapy with an outstanding user experience. We have pioneered the world’s first drug-free wearable therapy, clinically proven to alleviate symptoms in adults with drug-resistant Restless Legs Syndrome (RLS). Join us in transforming healthcare, improving lives, and driving meaningful change through innovative medical technology. We are seeking an experienced and strategic Director, Clinical Affairs to lead the planning, execution, and oversight of clinical studies supporting the development, regulatory approval, reimbursement, and commercialization of Noctrix Health’s medical devices. This leader will be accountable for the successful delivery of clinical programs, ensuring studies are executed efficiently, compliantly, on schedule, and within budget while generating high-quality clinical evidence that supports regulatory and business objectives. The Director, Clinical Affairs will serve as a key cross-functional leader and liaison among Clinical Affairs, Clinical Research, Regulatory Affairs, Quality, Product Development, and external partners. This individual will provide leadership across clinical operations, including sponsor oversight, site management, CRO and vendor management, clinical data quality, study execution, and evidence generation. This position reports to the Senior Vice President, Clinical & Regulatory Affairs . This is a full-time, hybrid position that is located at our Pleasanton headquarters. Responsibilities: Lead the planning, execution, and oversight of medical device clinical studies from study start-up through close-out Contribute to clinical development strategies supporting product development, regulatory submissions, reimburse

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 Sr. Regulatory Affairs Associate – CONSULTANT for 12 months Contract with possibility of extension to join one of our clients. ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts. About the Role J ob Title: Sr. Regulatory Affairs Associate – CONSULTANT Responsibilities: Regulatory Affairs Associate will actively collaborate with the Company’s regulatory project team to review, update, and create Technical Documents (TDs) in accordance with EU MDR and other applicable regulatory requirements. The high-level activities may include but are not limited to: Establish and maintain an understanding of EU MDR and other global medical device regulatory requirements Identify applicable regulatory requirements, harmonized standards, guidance documents, and submission expectations Draft, create or update TDs in collaboration with Platform RA SME. Review, obtain, and combine TF/DD documents in PLM or similar regulatory sources into Adobe PDF files Create and upload bookmarks/indexes of the Adobe PDF files into PLM via Change Orders. Perform Quality Control checks in accordance with client procedures, training, and checklists, including verification of completeness, correct pagination, and absence of blank or missing pages Perform Quality Control checks per Company’s procedure/training/checklist, e.g., verify all pages are present, no blank pages, etc., Verify TD documents are approved and contain the most recent revision(s) Work with the cross functional teams and Company’s

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 Sr. Regulatory Affairs Associate – CONSULTANT for 12 months Contract with possibility of extension to join one of our clients. ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts. About the Role J ob Title: Sr. Regulatory Affairs Associate – CONSULTANT Responsibilities: Regulatory Affairs Associate will actively collaborate with the Company’s regulatory project team to review, update, and create Technical Documents (TDs) in accordance with EU MDR and other applicable regulatory requirements. The high-level activities may include but are not limited to: Establish and maintain an understanding of EU MDR and other global medical device regulatory requirements Identify applicable regulatory requirements, harmonized standards, guidance documents, and submission expectations Draft, create or update TDs in collaboration with Platform RA SME. Review, obtain, and combine TF/DD documents in PLM or similar regulatory sources into Adobe PDF files Create and upload bookmarks/indexes of the Adobe PDF files into PLM via Change Orders. Perform Quality Control checks in accordance with client procedures, training, and checklists, including verification of completeness, correct pagination, and absence of blank or missing pages Perform Quality Control checks per Company’s procedure/training/checklist, e.g., verify all pages are present, no blank pages, etc., Verify TD documents are approved and contain the most recent revision(s) Work with the cross functional teams and Company’s local

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 brings experience at companies such as J.P. Morgan, Goldman Sachs, FalconX, PayPal, Affirm, Polygon, Kraken, Nium, Visa, Mastercard and others. We're backed by Accel, Lightspeed, M13, Northzone, Pantera, and other top-tier investors. About the Role As Commercial Legal Counsel, you will run the commercial deal desk end-to-end and be the lead lawyer supporting OpenFX’s Go to Market team. You will create new global contractual frameworks to support our expanding set of products and markets, create templates for our partnership arrangements with local financial institutions, build and manage a Contract Management System, and expand our processes leveraging AI to enable the Legal team to rapidly and efficiently review and negotiate agreements and onboard new clients. What You'll Do Own the full commercial contracting lifecycle for our global customer relationships. Build and maintain the commercial legal playbook - templates, fallback positions, approval thresholds, and escalation paths so standard deals close without bespoke lawyering. Create systems and processes enabling the team to leverage AI for first-pass contract review, issues lists, and clause comparison, and build reusable AI workflows that compress cycle times across the whole legal function. Advise the team on deal structure, pricing and fee terms, service levels, liability and indemnity positions, and settlement and funds-flow mechanics. Partner with regulatory Legal, Compliance, and Product on how regulatory requirements land in contract terms and customer-facing documentation. Serve as the lead Counsel advising the global Go to Market team. What You Sh

Hello potential future Oatly employee. It’s us, the original oatmilk company that started in Sweden back 25 or so years ago and has since expanded to the U.S. where we’ve continued growing at a rate such that we need more brilliant minds to come work with us to keep the momentum going and the oatmilk flowing. Sustainability, health, and transparency are the core values that guide everything we do. Basically, we exist to help people live a healthier life without recklessly taxing the planet’s resources in the process, and to change the food system for the better. We drive that change through the power of oats and through a significant reduction in cow’s milk consumption. If any of this resonates with you, then maybe you’d like to work for Oatly, too. Now onto the formal stuff. We are looking for a SQA Manager (External Manufacturing & Warehouse/Logistics) North America to join our team. This role will be responsible for ensuring food safety, quality, and regulatory compliance across external manufacturing partners, warehouses, and logistics providers supporting Oatly products in North America. Reporting to the Global Director, SQA, this role manages supplier quality and food safety for processes and products, ensuring products produced at Co Manufacturers are appropriately risk assessed, approved, released, or blocked in accordance with Oatly requirements, GFSI standards (BRCGS/SQF/ISO 22000), and FDA/FSMA Regulatory requirements. Here are the things we want to hire you to do: Supplier Quality Management – external manufacturing partners, warehouse and logistics Approve and manage external manufacturing, warehouse, and logistics partners from a quality and food safety perspective Ensure supplier compliance with Oatly standards, GFSI schemes, and regulatory requirements Approve new production lines (commissioning/validation) at new and existing external manufacturers Conduct supplier risk assessments, including HACCP and food safety plan reviews Own supplier audits, d

Hello potential future Oatly employee. It’s us, the original oatmilk company that started in Sweden back 25 or so years ago and has since expanded to the U.S. where we’ve continued growing at a rate such that we need more brilliant minds to come work with us to keep the momentum going and the oatmilk flowing. Sustainability, health, and transparency are the core values that guide everything we do. Basically, we exist to help people live a healthier life without recklessly taxing the planet’s resources in the process, and to change the food system for the better. We drive that change through the power of oats and through a significant reduction in cow’s milk consumption. If any of this resonates with you, then maybe you’d like to work for Oatly, too. Now onto the formal stuff. We are looking for a SQA Manager (Direct Material & Release) North America to join our team. This role will be responsible for ensuring food safety, quality, and regulatory compliance of direct materials used in Oatly products in North America. This role manages supplier quality and food safety for direct materials and serves as release authority, ensuring products produced at Co Manufacturers are risk assessed, approved, released, or blocked in accordance with Oatly requirements, GFSI standards (BRCGS/SQF/ISO 22000), and FDA/FSMA Regulatory requirements. Here are the things we want to hire you to do: Supplier Quality Management – Direct Materials (raw material and packaging material) Approve and manage direct material suppliers from a quality and food safety perspective in line with applicable regulatory and Oatly requirements Ensure supplier compliance with Oatly standards, GFSI schemes, and regulatory requirements Conduct supplier risk assessments, including HACCP and food safety plan reviews Own supplier audits, deviation management, and CAPA follow-up Drive supplier performance through KPIs and supplier development plans, in line with global strategy Release & Positive Release Management A

Hello potential future Oatly employee. It’s us, the original oatmilk company that started in Sweden back 25 or so years ago and has since expanded to the U.S. where we’ve continued growing at a rate such that we need more brilliant minds to come work with us to keep the momentum going and the oatmilk flowing. Sustainability, health, and transparency are the core values that guide everything we do. Basically, we exist to help people live a healthier life without recklessly taxing the planet’s resources in the process, and to change the food system for the better. We drive that change through the power of oats and through a significant reduction in cow’s milk consumption. If any of this resonates with you, then maybe you’d like to work for Oatly, too. Now onto the formal stuff. We are looking for a Senior Q&RA Project Lead, Market & Innovation to join our team. This role will be responsible for leading strategic and operational quality and regulatory activities across innovation and product development, ensuring scalable, compliant, and efficient product launches. This is a hybrid role, working on-site in our Philadelphia location (3 days) and remote (2 days). Due to business needs, the qualified candidate will reside in the Philadelphia metro area. Here are the things we want to hire you to do: Act as the Q&RA lead and subject matter expert within global innovation and product development projects from concept through launch Lead product and process risk assessments, define quality and food safety criteria, and ensure stage-gate deliverables are met Coordinate cross-functional Q&RA work streams across SQA, Regulatory Affairs, and Compliance teams Drive implementation and continuous improvement of Q&RA frameworks, processes, and PD (product development) flows Ensure end-to-end compliance across food safety, quality, and regulatory requirements for all new products and changes Oversee validation strategies and challenge launch readiness decisions Act as escalation poin