When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Regional Submission Coordinator – Associate Position Overview The Regional Submission Coordinator – Associate - supports the execution and coordination of regulatory submission and labeling activities across assigned countries within a region. Reporting to the Regional Submission Coordinator (Lead), this role focuses on operational delivery, documentation coordination, system updates, and labeling execution to ensure timely, compliant, and high-quality regulatory submissions. The Associate works in close collaboration with the Lead, Regional Regulatory Leads (RRLs), Local Regulatory Responsibles (LRRs), Regulatory Partner Representatives (RPRs), and cross-functional stakeholders. Key Responsibilities – Submission Coordination & Operational Support • Support the coordination, preparation, and delivery of regulatory submissions and lifecycle management (LCM) activities in accordance with submission strategies defined by the RRL and coordinated by the Regional Submission Coordinator (Lead). • Assist in organizing submission team meetings (e.g., Kick-off Meetings) and follow up on agreed actions. • Coordinate, request, and track documentation from Subject Matter Experts (SMEs) to support submission readiness and timelines. • Support the preparation and maintenance of the Submission Content Plan (SCP) under the guidance of the RSC Lead. • Ensure timely dispatch of non-eCTD submission packages to LRRs and RPRs and track dispatched documentation per country. Key Responsibilities – Labeling Operational Support • Provide hands-on operational support for labeling activities, performing assigned tasks under the guidance of the RSC Lead. • Prepare annotated labeling documents for regulatory review in collaboration with RRLs, LRRs, and RPRs. • Initiate and coordinate mock-up requests in the Artwork Management System. • Track print releases as required. • Support change control activities related to local labeling updates. • Ensure appropriate archiving of labeling documentation and that approved labeling is accurately and timely stored in DocNet. Key Responsibilities – Regulatory Systems & Documentation • Support the creation, maintenance, and accuracy of submission and regulatory records in regulatory systems (e.g., Veeva RIMS, Apollo). • Upload Module 1 and non-eCTD submission documents to DocNet and ensure completeness and traceability. • Update regulatory systems with Health Authority interactions, including uploading questions received from Health Authorities in the appropriate records. • Support data quality and consistency across systems and documentation repositories. Project Support & Communication • Provide regular status updates to the Regional Submission Coordinator (Lead) on assigned activities, timelines, and potential issues. • Support tracking of submission milestones, deliverables, and dependencies. • Escalate operational issues or delays to the RSC Lead with appropriate context and proposed mitigation actions. • Collaborate effectively with cross-functional teams including CMC, labeling, quality, and regulatory stakeholders. Quality & Compliance • Perform assigned activities in compliance with applicable SOPs, work instructions, and regional regulatory requirements. • Support inspection readiness by ensuring accurate, complete, and well-organized submission and labeling documentation. • Maintain awareness of regional regulatory processes relevant to assigned activities and follow guidance provided by the Lead and RRLs. Required Qualifications • Bachelor’s degree in Life Sciences, Pharmacy, or a related discipline. • 1–3 years of experience in regulatory affairs, regulatory operations, or a related pharmaceutical/biotechnology role. • Good understanding of regulatory submission processes and lifecycle management activities. • Experience or familiarity with regulatory information management systems (e.g., Veeva RIMS) and document management tools. • Strong organizational skills with attention to detail and quality. • Ability to manage multiple tasks and timelines in a matrix environment. • Effective written and verbal communication skills in English and Spanish (mandatory) Key Competencies Technical Competencies: • Regulatory submission documentation and coordination • Labeling operational support and artwork coordination • Regulatory systems and data management Professional & Behavioral Competencies: • Attention to detail and quality orientation • Strong organizational and follow-up skills • Collaborative mindset and stakeholder support • Adaptability in a fast-paced, cross-regional environment • Team-oriented approach with a service mindset

Company Description Are you ready to trade your job for a journey? Become a FlyMate! Passion, excitement & global collaboration are all core to what it means to be a FlyMate. At Flywire, we’re on a mission to deliver the world’s most important and complex payments. We use our Flywire Advantage - the combination of our next-gen payments platform, proprietary payment network and vertical specific software, to help our clients get paid, and help their customers pay with ease - no matter where they are in the world. What more do we need to truly be unstoppable? Perhaps, that is you! Who we are: Flywire is a global payments enablement and software company, founded more than a decade ago to solve high-stakes, high-value payments in higher education. We’ve since scaled into new regions and industry verticals and expanded our product offerings to deliver meaningful value to our clients around the world. Today we support more than 4,800 clients across the global education, healthcare, travel & B2B industries, with diverse payment methods across 240 countries & territories and more than 140 currencies. With over 1,200 global FlyMates, representing more than 40 nationalities, and in 12 offices world-wide, we’re looking for FlyMates to join the next stage of our journey as we continue to grow. Job Description The Opportunity: Flywire thrives on developing and bringing to market innovative payments solutions. We believe that building and operating an outstanding company goes hand-in-hand with acting in a regulatorily compliant manner at all times. To support our continued growth worldwide and our expansion in the Canadian market, Flywire is seeking a dedicated and experienced Compliance Officer / MLRO to lead these efforts. The role will be Remote and will report to the Head of Compliance in the US. Flywire operates within a complex global system of laws and regulations to provide our services to customers in the education, healthcare, travel and B2B sectors. As we expand our service offerings in Canada to serve new verticals, we need an experienced Compliance and Regulatory trained leader to work cross-functionally and across multiple jurisdictions to create programs, administer filings and instill compliant processes that facilitate the launch and growth of Flywire products within a FINTRAC and Bank of Canada regulated entity. This will be a varied role working within our Financial Crimes Compliance team, leading and overseeing our Canada AML programs and FINTRAC / Bank of Canada -compliant regulatory work -- liaising with regulators, auditors, bank/payment partners, and clients, while building a program to monitor and comply with relevant evolving regulation – including maintaining appropriate localized governance to do the same. You will find yourself working closely with stakeholders from our Product, Global Payments, Risk, Business, and Operations functions. You should be comfortable supporting sometimes complicated, global and regulated products that require analysis on several fronts. The Canadian Compliance & Regulatory Manager will assist the organization by: - Monitoring relevant Canadian regulatory developments, particularly as they relate to payments regulation, consumer protection, money service business and fintech laws generally; - Supporting the Global Payments team on ongoing bank and payment partner management, including explaining our global Legal, Compliance and Regulatory framework and conducting onsite visits if needed; - Assisting with analysis and introduction of new products and services; - Managing Canadian Regulator and Law Enforcement relationships and interactions, if any; - Reviewing the regulatory environment for Flywire’s suite of services, determining if licensure or additional permissions are required or an exemption applies (and under what circumstances); - Building and maintaining needed Canadian AML/CTF programs, policies and procedures; - Assisting the Global AML/CTF compliance operations team, including sanctions screening, transaction monitoring, fraud monitoring and KYC; - Managing the regulatory reporting (EFTR, STR) and response process, by ensuring clear allocation of responsibilities for regularly scheduled and ad hoc filings, and maintaining a repository of prior filings and information used to respond to regulatory inquiries or consultations; - Coordinate and develop presentations, responses and reporting to management, regulators, clients, FI Partners and governing bodies, as required; - Assist with development of internal communications, presentations, and training materials; - Conducting regulatory reviews and due diligence on potential business acquisition targets, as required; - Maintain documentation on regulatory requests supported and responses provided; - Support additional Risk Governance projects and initiatives as needed; - Support global artificial intelligence development as it relates to AML/CTF and sanctions regulations - Drive and own the regulatory compliance aspects of our business in Canada and advise on AML regulations; - Localize and administer an AML/CFT compliance program and maintain a risk assessment to comply with applicable local requirements -- including transaction monitoring functions; - Work on various projects and miscellaneous issues both in Canada and globally such as partner KYC audits, client onboarding, and product enhancements; - Create insights on regulatory and supervisory topics for effective business response and mature risk governance practices Qualifications Here's what we're looking for: Basic Qualifications - 5-10 years of work experience with a university degree, or at least 8 years of relevant work experience Preferred Qualifications - 8+ years of relevant experience in certain of the following functions: Anti-Money Laundering Corporate/Risk Governance, Risk Management, Compliance, Audit, Regulatory Management, Legal or related areas - Capable of comfortably leading meetings, delivering presentations and interact with all hierarchy levels - Able to pursue multiple initiatives simultaneously - Experience with regulations and guidelines related to payments networks, financial institutions, digital payments industry, including emerging payment system regulation/supervision - Data driven and experience with analytics - Experience preparing/reviewing/delivering executive level communications - Experience in payments/banking or related segments, or alternately, good understanding of payments business and associated risks - Excellent written and verbal communications skills - Fluent in English (verbal and written). French (Canadian) would be a plus Additional Information What We Offer: - Competitive compensation - Employee Stock Purchase Plan (ESPP) - Flying Start - Our immersive Global Induction Program (Meet our Execs & Global Teams) - Work with brilliant people that will keep you on your toes, learn more about their journeys by checking out #InsideFlywire on social media - Dynamic & Global Team (we have been collaborating virtually for years!) - Wellbeing Programs (Mental Health, Wellness, Yoga/Pilates/HIIT Classes) with Global FlyMates - Competitive time off including FlyBetter Days to volunteer in your community and Digital Disconnect Days! - Great Talent & Development Programs (Managers Taking Flight – for new or aspiring managers!) Submit today and get started! We are excited to get to know you! Throughout our process you can expect to meet different FlyMates including the Hiring Manager and other Flymates. Your Talent Acquisition Partner will walk you through the steps and be your “go-to” person for questions. Flywire is an equal opportunity employer. With over 40 nationalities across 12 different offices, and diversity and inclusion at the core of our people agenda, we believe our FlyMates are our greatest asset, and we’re excited to watch our unique culture evolve with each new hire. The base salary range for this full-time position is $140,000 - $150,000 CAD and benefits. Our salary ranges are determined by role, position level, and location. The range displayed on this job posting reflects the minimum and maximum target for new hire salaries for the position across all locations. Within the range, individual pay is determined by work location and several other factors, including job-related skills, experience, relevant education and training. #LI-Remote

Job Description At Achieve, we're helping everyday people go from surviving to thriving, and the stories of that transformation are some of the most powerful marketing assets we have. We're looking for a Marketing Specialist who can work across a range of connected disciplines: reputation management, brand advocacy, content pipeline development, and the customer-facing messaging that guides people through our product experience. This is a role for someone who is equal parts curious analyst and creative thinker, someone who can mine data and reviews for signal, map how customers move through a journey, and help shape what we say to them at the moments that matter most. If you've been looking for a place to go deeper on AI-powered marketing workflows with a team that's already doing it, this is that place. What you'll do - Customer Journey & Nurture: Help think through the end-to-end customer experience, identifying key touchpoints, contributing to nurture flow development, and ensuring the right message reaches the right person at the right moment across email, product, and digital channels. - Reputation Management: Support execution of our reputation management strategy across brands, working to grow and optimize our presence on key external review platforms and digital partner channels, analyzing trends, identifying gaps, and contributing to measurable improvement. - Content Pipeline: Help build and maintain the program infrastructure that feeds a multi-channel video and content pipeline, sourcing customer reviews and program outcomes, identifying the stories worth telling, and moving assets into production for use across social, PR, and editorial channels. - Advocacy and Ambassador Programs: Support and help grow our brand ambassador programs, including both employee advocacy and customer champion initiatives, identifying and activating the voices that best represent our mission. - Insights & Reporting: Synthesize data and reporting across programs, translating findings into clear insights and recommended actions for internal stakeholders and leadership. - AI-Powered Workflows: Partner with the Integrated Director to identify, build, and iterate on AI-powered workflows, including agentic use cases, that increase the team's speed, scale, and impact. Qualifications What you'll bring - 2+ years of experience in marketing, integrated communications, or business operations, including hands-on execution of programs that span multiple teams or channels. - Some exposure to or curiosity about customer journey mapping, nurture flows, or how messaging ladders through a product or campaign experience, you don't need to be a product marketer, but you should be able to think like a customer. - Demonstrated ability to contribute to structured programs with measurable outcomes (marketing campaigns, advocacy programs, employee or customer engagement initiatives, or similar). - Genuine curiosity about AI and how it applies to marketing work. Hands-on experience with tools like Claude, ChatGPT, Perplexity, NotebookLM, or building custom workflows (GPTs, Gems, agents) is a real differentiator here, but the right mindset matters as much as the resume. - Strong writing and communication skills across formats: documents, briefs, presentations, and stakeholder updates. - Data fluency, comfortable in Google Sheets, Slides, and Microsoft Office; able to synthesize and present findings clearly. - Exposure to multi-channel marketing environments: social, PR, content, or communications. - Experience in financial services or communications is a bonus, not a requirement. Why This Role This isn't a single-track role - it's a chance to develop range across brand, content, customer experience, and AI-powered marketing, all within a team that's actively building rather than just planning. You'll be embedded with people who have deep marketing expertise and real, hands-on AI practice. If you've experimented on your own and want to level up in a structured, innovative environment alongside people who take this seriously, this is a strong next step. Salary Range: $60,000 to $75,000 annually + bonus + benefits. This information represents the expected salary range for this role. Should we decide to make an offer for employment, we'll consider your location, experience, and other job-related factors. Additional Information Achieve well-being with: - Hybrid and remote work opportunities - 401 (k) with employer match - Medical, dental, and vision with HSA and FSA options - Competitive vacation and sick time off, as well as dedicated volunteer days - Access to wellness support through Employee Assistance Program, and Talkspace, - Up to $5,250 paid back to you on eligible education expenses - Pet care discounts for your furry family members - Financial support in times of hardship with our Achieve Care Fund - A safe place to connect and a commitment to diversity and inclusion through our six employee resource groups Join Achieve, change the future. At Achieve, we're changing millions of lives. From the single parent trying to catch up on bills to the entrepreneur needing a loan for the next phase of growth, you'll get to be a part of their journey to a better financial future. We're proud to have over 3,000 employees in mostly hybrid and 100% remote roles across the United States with hubs in Arizona, California, and Texas. We are strategically growing our teams with more remote, work-from-home opportunities every day to better serve our members. A career at Achieve is more than a job-it's a place where you can make a true impact, have a sense of belonging, establish a fulfilling career, and put your well-being first. Attention Agencies & Search Firms: We do not accept unsolicited candidate resumes or profiles. Please do not reach out to anyone within Achieve to market your services or candidates. All inquiries should be directed to Talent Acquisition only. We reserve the right to hire any candidates sent unsolicited and will not pay any fees without a contract signed by Achieve's Talent Acquisition leader. Company Description Achieve is a leading digital personal finance company. We help everyday people move from struggling to thriving by providing innovative, personalized financial solutions. By leveraging proprietary data and analytics, our solutions are tailored for each step of our member's financial journey to include personal loans, home equity loans, debt consolidation, financial tools and education. Every day, we get to help our members move their finances forward with care, compassion, and empathetic touch. We put people first and treat them like humans, not account numbers.

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. We are currently seeking a Principal Regulatory Affairs Specialist to join our global Regulatory Affairs department, Reg Science team. This is a fantastic opportunity to further develop your regulatory career and expertise in a global clinical trial setting. In this role you will be a pivotal team member with regulatory affairs responsibilities, leading discussions, and coordinating regulatory strategies globally on assigned (Phase 1 to 4) clinical trials, studies and projects. You will be part of a global team providing innovative solutions and global regulatory expertise, being client interfacing to provide strategic regulatory intelligence and guidance. You will feel confident providing regulatory advice and carry out projects in the provision of regulatory affairs services whilst acting as liaison with internal and external clients. You will act as a representative of the regulatory department with other departments, supporting business development, working on initiatives, and contributing to quality improvement. You will also arrange, lead, and report on client and regulatory agency meetings. The following skills are required to be successful in this position: - preparation and assembly of global regulatory submissions (CTA) - interacting with sponsors, - review and assess clinical trial regulatory documents, - review and assess scientific literature. - manages project teams and preparation - participate in launch meetings, review meetings and project team meetings. - Experience with bid defense meetings Qualifications What the role requires you to have: - Bachelor's degree or advanced degree preferred, or equivalent and relevant formal academic / vocational qualification - Previous experience that provides the knowledge, skills, and abilities to perform the job comparable to 8+ years - Knowledge of the global clinical trials landscape Knowledge, Skills and Abilities: - Excellent command of the English language (written and oral) as well as local language where applicable - Experience with Bid Defense meetings - Experience in leading global regulatory projects for Clinical Trial Applications - Excellent attention to detail and quality as well as excellent editorial/proofreading skills - Exceptional interpersonal skills to work effectively in a team environment and act as a liaison with other departments - Advanced computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies - Strong organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects - Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables - Excellent understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization; expert knowledge of ICH and other global regulatory guidelines - Excellent analytical, investigative and problem-solving skills What we offer: At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD clinical research services you will benefit from an award-winning learning and development programme, ensuring you reach your potential. As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD clinical research services truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued. Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.