Regulatory Affairs Cmc Associate Jobs

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 make it easy for people to eat better and live healthier lives without recklessly taxing the planet’s resources in the process. 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 Quality & Food Safety Manager to join our team. This role will be responsible for overseeing the day-to-day operations and long-term planning of quality functions at manufacturing facility from Receiving, Production and Distribution Operations. The Quality Manager must have experience and working knowledge of quality programs and have familiarity with US and international markets and their requirements. This position has direct reports and interfaces heavily with Plant Management and their teams as well as continuous improvement with global quality. This position requires a cooperative team approach and a clear and consistent communication style. Here are the things we want to hire you to do: · Manage all day-to-day quality programs in a hands-on, highly engaged leadership fashion to ensure that the · Company maintains its marketplace reputation for having the highest quality products in the industry. · Responsible for maintaining world-class levels of product quality in company-operated manufacturing facilities and establishing quality specifications. · Leading the quality department on daily operational and strategic level. · Review and maintain existing quality assurance procedures and developing comprehensive plan to significantly upgrade Company’s quality program and work with Senior Leadershi

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

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 Legal Counsel to serve as a strategic partner and legal advisor across our business, with a particular focus on licensing (MiCAR / PSD2), financial product development and financial 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

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 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 across mu

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

Job Description Job Title: Senior Executive / Specialist - Case Processing E mployment Type: Contract Location: Brazil (Remote) A bout 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, 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: Experience in Intake/Triage, Data Entry, Quality Review, Case Finalization/Distribution of cases received from sources such as Spontaneous, Literature, Regulatory Authority, Solicited and Clinical trials. Experience in raising follow-up queries, as necessary, with appropriate documentation in the safety database. Experience in ARGUS database. Experience in rare disease portfolio. Must possess thorough knowledge of ICH-GCP, relevant GVP module, 21 CFR guidelines and other regulatory requirements. Training and mentoring skill (ICSR, Safety database etc.). Candidate Profile: Bachelor’s or Master’s in Pharmacy / Life Sciences or above and in alignment with project / business team requirements. Minimum of 3 to 5 years of relevant experience in identified functional domain/ business workstream. Must have hands on experience with MS office applications (Outlook, Excel, Word, Power Point

Dear Candidate We have immediate vacancies for the post of Chemist, Microbiologist, Production, Quality Assurance, Quality Control, Regulatory Affairs, R & D, Pharma, Research Associate, Lab Asst. Qualification : BSc / MSc Freshers and Experienced Salary : 4 Lakhs Per Annum to 9 LPA Contact Mr Vasanth Managing Director 7353549756 / 8722187029 Karnataka Information Solution No.6, Basement Floor, ASVNV Bhavan, Opp State Bank Of India, K.G Road, Majestic, Bangalore - 09 PH : 080 - 22260106.

Work Flexibility: Hybrid About the role Join a regional operations team focused on inventory control and data accuracy across Latin America. As Lead Analyst, Global Inventory Operations, you will execute and monitor inventory reconciliation, discrepancy resolution, inventory control activities, and reporting processes that support operational execution and financial reporting across distribution sites and third-party logistics providers (3PLs). This role partners closely with Operations, Finance, Quality, Regulatory Affairs, Information Technology, Customer Service, and external logistics providers to maintain inventory integrity and compliance. What you will do Execute inventory reconciliations between enterprise resource planning (ERP) systems and warehouse management systems (WMS) at SKU, lot/batch, serial, quantity, and location levels. Investigate inventory variances, perform root cause analysis, and coordinate corrective actions to improve inventory accuracy and reduce recurring discrepancies. Maintain reconciliation action logs, track issue aging, assign ownership, and monitor resolution progress against established timelines. Monitor inventory-related system interfaces, identify transaction failures or delays, and coordinate issue resolution with internal teams and logistics partners. Coordinate cycle count programs and annual physical inventory activities, ensuring compliance with company policies and inventory control procedures. Measure and report inventory performance indicators, including inventory accuracy, cycle count accuracy, inventory adjustments, discrepancy aging, and inventory disposal activity. Analyze inventory trends, recurring exceptions, and process performance data to identify operational improvement opportunities. </

Responsibilities Set and lead the country/regional patient advocacy strategy, aligned with business, policy and reputation priorities. Build trusted, long-term partnerships with patient, professional, community and trade organizations; serve as the senior point of contact for priority relationships. Bring patient insights and the patient voice into policy, research, development, medical and commercial decision-making across the medicine lifecycle. Create coalitions and collaborative platforms that advance shared policy priorities, improve access to medicines and vaccines, and strengthen patient education. Advise senior leaders on emerging patient, policy and reputation opportunities and risks, with clear short-, medium- and long-term action plans. Partner across Policy and Public Affairs, Communications, Digital, WRDM (Worldwide Research, Development and Medical), GPD (Global Product Development) and business teams to scale patient-engagement standards, tools and best practices. Represent Pfizer in relevant external forums and advisory bodies and lead high-impact advocacy engagements and events. Core Competencies Strategic leadership and sound judgment Patient organization management and trusted relationship building Influence, collaboration and coalition building Clear, credible executive communication Execution, accountability and agility Key Relationships Internal: Patient Advocacy leadership; Policy and Public Affairs; Communications; Commercial; Medical; Regulatory Affairs; Digital; Research and Development; and other enterprise stakeholders. External: Patient and professional advocacy organizations, community and provider groups, trade associations, policy thought leaders and other relevant partners. Qualifications Bachelor’s degree requi

Work Flexibility: Hybrid Position summary: This role will support a wide range of products across multiple surgical specialties, with a primary focus on post-market design support and product performance. Working closely with Quality, Marketing, Operations and Regulatory Affairs, you will investigate customer complaints, field returns and product performance trends to identify opportunities for improvement and support implementation of design changes. Product Engineering offers a unique opportunity to learn how medical devices perform throughout their entire lifecycle. You will develop deep product knowledge by working on real-world engineering challenges, gaining firsthand experience of how products are designed, manufactured, used by customers and perform in the field. Through investigation of product issues and implementation of improvements, you will help enhance product quality, reliability and customer experience, while contributing valuable insights that influence future product enhancements and next-generation designs. What you will do: Support post-market design activities for commercially released medical devices, helping to ensure products continue to meet customer, quality and regulatory requirements. Investigate customer complaints, field returns and product performance issues using structured problem-solving and root cause analysis techniques. Partner with Quality, Marketing, Operations and Regulatory Affairs to identify opportunities for product improvements and support implementation of design changes. Plan and execute engineering testing, verification and validation activities to evaluate product performance and support proposed design improvements. Support Nonconformance (NC), Corrective and Preventive Action (CAPA), and Engineering Change Request (ECR) activities while maintaining compliant engineering do

Work Flexibility: Hybrid As a Post Market Quality Engineer, you will be responsible for continuous product and process quality improvements. You will conduct investigations into Customer Complaints, identify emerging trends, dictate action plans, and eventually own NC/CAPAs. You will support root cause activities and identify potential failure modes, risks, and resolve customer issues appropriately. This role is Hybrid/Onsite in Redmond, Washington. What You Will Do Analyze and present post-market quality data including complaints, service reports, Q-metrics, and trending to identify continuous improvement opportunities. Investigate customer complaints and drive records to timely closure. Own and support Nonconformance (NC) and Corrective and Preventive Action (CAPA) investigations. Partner with customers and cross-functional teams including R&D, Regulatory Affairs, Field Service, and Sales to resolve product quality issues. Conduct and maintain risk analyses, document findings, and support Risk Management activities. Calculate failure and harm occurrence ratings using field performance data. Provide post-market quality input related to product safety, reliability, durability, and design performance. Ensure compliance with Quality System Regulations (QSRs), internal procedures, and applicable quality standards. Communicate product quality insights and trends to internal and external stakeholders. What You Need Bachelor's degree in Engineering, Science, or a related technical discipline. 0 - 2 years of professional experience. Strong analytical and problem-solving skills. Excellent communication and collaboration skills. Ability to manage multiple priorities and work effectively in a fast-paced environme

About the Team OpenAI’s Legal team supports OpenAI’s mission by addressing complex legal issues arising from the development and deployment of AI. The team brings together expertise in commercial, corporate, employment, privacy, intellectual property, regulatory, tax and litigation matters, and works closely with teams across the company. About the Role We’re seeking an experienced, hands-on lawyer to serve as our country lawyer for France, providing broad legal support for our local office with a primary focus on regulatory and policy legal matters affecting OpenAI’s products, operations and business. You will advise on French and EU regulatory developments, develop practical legal positions and recommendations, and support OpenAI’s engagement with French regulators and policymakers. Working closely with EMEA and global legal colleagues, as well as policy and regulatory affairs teams, you will take ownership of assigned French matters, translate complex legal questions into actionable advice and help ensure that our approach in France is consistent with OpenAI’s wider legal positions. Alongside your primary focus, you will also provide broader French country legal support, coordinating with specialist teams on local business and operational matters. We’re looking for someone who can take responsibility for matters, give practical advice, manage competing priorities and bring cross-functional work to a decision. You will work closely with EMEA and global legal colleagues, GA and Policy leaders, applying established specialist guidance, approval processes and escalation routes. In this role, you will: Advise on regulatory developments and their business implications. Assess existing and emerging French and EU laws, enforcement developments and policy proposals affecting OpenAI. Develop legal positions and practical recommendations, working with GA, Policy, Regulatory, Product, Privacy and other legal teams to translate requirements into action. Serve as a trusted leg

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: 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

Job Description – Medical Writer / Medical Reviewer (Ovarian Cancer Oncology Expertise) Position Title Medical Writer / Medical Reviewer – Oncology (Ovarian Cancer) Location Remote / Hybrid Position Summary We are seeking an experienced Medical Writer or Medical Reviewer with expertise in Ovarian Cancer and Gynecologic Oncology to support the development, review, and delivery of high-quality scientific and medical content. The successful candidate will collaborate with Medical Affairs, Clinical Development, Regulatory Affairs, Biostatistics, and external experts to ensure scientific accuracy, compliance, and timely execution of deliverables. The role requires a strong understanding of ovarian cancer biology, treatment landscape, clinical trial data, and publication practices. Key Responsibilities Medical Writing Develop and review scientific and medical materials, including: Clinical study reports (CSRs) Protocols and amendments Investigator brochures Manuscripts, abstracts, and posters Slide decks and educational materials Medical information responses and FAQs Congress presentations and publication plans Summarize and interpret clinical data related to ovarian cancer therapies and biomarkers. Ensure consistency with ICH, GCP, GPP, and company standards. Conduct literature reviews and evidence synthesis from peer-reviewed journals and congress proceedings. Collaborate with cross-functional teams to support regulatory submissions and medical affairs activities. Medical Review Perform scientific and medical review of promotional and non-promotional materials. Verify scientific accuracy, consistency, and compliance with regulatory requirements. Review clinical data, references, and claims for accuracy and balance. Support MLR (Medical-Legal-Regulatory) review processes. Provide expert input regarding ovarian cancer treatment guidelines and emerging therapies. Scientific Expertise Maintain current knowledge of: Epithelial ovarian cancer Platinum-sensitive and platinum-