Regulatory Affairs Associate remote jobs

GeneDx (Nasdaq: WGS) delivers personalized and actionable health insights to inform diagnosis, direct treatment, and improve drug discovery. The company is uniquely positioned to accelerate the use of genomic and large-scale clinical information to enable precision medicine as the standard of care. GeneDx is at the forefront of transforming healthcare through its industry-leading exome and genome testing and interpretation services, fueled by the world's largest, rare disease data sets. For more information, please visit *************** Summary The Senior Regulatory Affairs Associate will play a key role in supporting GeneDx's delivery of high-quality IVD products and services, ensuring compliance with applicable FDA and ISO requirements. The position requires working expertise in ISO 13485, ISO 14971, ISO 15189, and IEC 62304 for IVD medical devices. The associate will collaborate cross-functionally with Development Lab, Product, Technology, Medical Affairs, and the Lab Director to support regulatory activities throughout the product lifecycle. Job Responsibilities Support the development and execution of regulatory strategies to ensure FDA authorization and global compliance for IVD and Software as a Medical Device (SaMD) products. Prepare and contribute to regulatory submissions, including FDA pre-submissions, 510(k), De Novo, and EU IVDR Technical Documentation. Collaborate with cross-functional teams to ensure regulatory requirements are integrated throughout the product lifecycle. Provide regulatory input during design and development activities, including risk management, change control, verification/validation, and labeling. Monitor and interpret evolving regulatory requirements and standards (e.g., ISO 13485, ISO 14971, IEC 62304, IEC 62366) and assess impact on product development and compliance. Support internal audits and regulatory inspections, including preparation of documentation and development of CAPAs related to regulatory findings. Deliver regulatory training and guidance to internal teams to support ongoing compliance and foster a strong quality and regulatory culture. Contribute to continuous improvement initiatives within the Regulatory Affairs function. People Manager No Education, Experience, and Skills A bachelor's or advanced degree in a relevant scientific or technical field (e.g., Biology, Chemistry, Engineering). Minimum of 5 years of experience in regulatory affairs within the medical device or IVD industry. Practical experience with FDA authorization and EU IVDR submissions, design controls, ISO 13485, ISO 14971, IEC 62304 and ISO 15189 regulations. Experience with Software as a Medical Device or medical devices containing software. Working experience in a clinical genetics laboratory is desired. Ability to manage multiple projects and priorities in a fast-paced environment. Certificates, Licenses, Registrations Regulatory Affairs Professional Certification (RAC) preferred. Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. Ability to sit for extended periods. Work Environment Work is primarily performed in a remote office setting. Acknowledgements The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor. #LI-REMOTE Pay Transparency, Budgeted Range$110,000-$120,000 USD ~ Science - Minded, Patient - Focused. At GeneDx, we create, follow, and are informed by cutting-edge science. With over 20 years of expertise in diagnosing rare disorders and diseases, and pioneering work in the identification of new disease-causing genes, our commitment to genetic disease detection, discovery, and diagnosis is based on sound science and is focused on enhancing patient care. Experts in what matters most. With hundreds of genetic counselors, MD/PhD scientists, and clinical and molecular genomics specialists on staff, we are the industry's genetic testing experts and proud of it. We share the same goal as healthcare providers, patients, and families: to provide clear, accurate, and meaningful answers we all can trust. SEQUENCING HAS THE POWER TO SOLVE DIAGNOSTIC CHALLENGES. From sequencing to reporting and beyond, our technical and clinical experts are providing guidance every step of the way: TECHNICAL EXPERTISE High-quality testing : Our laboratory is CLIA certified and CAP accredited and most of our tests are also New York State approved. Advanced detection : By interrogating genes for complex variants, we can identify the underlying causes of conditions that may otherwise be missed. CLINICAL EXPERTISE Thorough analysis : We classify variants according to our custom adaptation of the most recent guidelines. We then leverage our rich internal database for additional interpretation evidence. Customized care : Our experts review all test results and write reports in a clear, concise, and personalized way. We also include information for research studies in specific clinical situations. Impactful discovery : Our researchers continue working to find answers even after testing is complete. Through both internal research efforts and global collaborations, we have identified and published hundreds of new disease-gene relationships and developed novel tools for genomic data analysis. These efforts ultimately deliver more diagnostic findings to individuals. Learn more About Us here. Our Culture At GeneDx, we are dedicated to cultivating an environment where creativity and innovation thrive. We believe in the power of community and collaboration, where diverse perspectives are embraced, and every voice contributes to our shared success. Our team is a vibrant mix of professionals who challenge and support each other in equal measure, fostering growth both personally and professionally. When you join us, you're not just taking on a job-you're joining a movement. A movement that champions curiosity, embraces change, and believes in making an impact, one patient at a time. Cultural principles we live by: Be bold in our vision & brave in our execution. Communicate directly, with empathy. Do what we say we're going to do. Be adaptable to change. Operate with a bias for action. Benefits include: Paid Time Off (PTO) Health, Dental, Vision and Life insurance 401k Retirement Savings Plan Employee Discounts Voluntary benefits GeneDx is an Equal Opportunity Employer. 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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 are seeking a Head of Americas Licensing and Regulatory Affairs to join our dynamic team. The role will be responsible for driving our acquisition of U.S. state money transmitter licenses and subsequent management of those licenses and our relationships with U.S. state regulators, as well as the acquisition of other licenses to support the rapid growth of our business in the U.S., Canada and Latin America. This role is crucial for enabling our global expansion while maintaining regulatory compliance and strong relationships with regulatory authorities. Key Responsibilities: Licensing Acquisition & Maintenance Complete execution of pending US state money transmitter license (MTL) applications: Complete preparation, coordination, and submission of MTL applications across all required US states, managing multiple applications simultaneously through approval Drive scoping and execution of additional license applications in the Americas: Prepare and submit Money Services Business (MSB) registration in Canada, obtain required U.S. crypto/virtual currency licenses, and secure any required licenses across key Latin American markets. Coordinate with external counsel and consultants: Manage relationships with licensing consultants and outside counsel to ensure high-quality, cost-effective support aligned with business needs Manage license maintenance activities: Oversee all post-licensing obligations including renewals, amendments, quarterly/annual reporting, surety bond management, net worth requirements, and permissible investment compliance Regulatory Relations and Compliance Operations Serve as primary regulatory contact: Act as OpenFX's main point of contact with state banking departments, FinCEN, and other US regulators, as well as FINTRAC (Canada) and Latin American financial authorities Build and maintain regulator relationships: Establish positive, proactive relationships with key regulatory bodies, positioning OpenFX as a compliant and transparent operator Manage regulatory inquiries and examinations: Lead preparations for and responses to regulatory examinations, audits, inquiries, and requests for information from state and federal regulators Prepare regulatory submissions: Draft, review, and submit all regulatory filings, notifications, reports, and correspondence with accuracy and within required timelines Prepare and manage regulatory reports and filings: Coordinate with Finance and other internal stakeholders to submit quarterly, semi-annual, and annual financial and operational reports required under various licenses Cross-Functional Collaboration Support market expansion: Work with internal teams to identify regulatory requirements for new markets and develop paths to licensure Maintain policies and procedures: Review and update regulatory policies, procedures, and compliance manuals to reflect current requirements Build and develop the team: As the business scales, recruit and manage licensing and regulatory professionals What we are looking for Required Qualifications 7+ years of experience in regulatory licensing, regulatory affairs, or regulatory compliance within financial services, fintech, or payments companies Proven track record of successfully obtaining and maintaining financial services licenses, particularly US state money transmitter licenses Strong knowledge of US state money transmission regulatory frameworks, including application processes, surety bond requirements, net worth rules, and examination procedures Regulatory filing expertise: Demonstrated experience preparing and submitting regulatory reports, notifications, and responses to regulatory inquiries Regulator relationship experience: Track record of successfully interfacing with state banking departments, FinCEN, and other financial regulators Exceptional project management skills: Ability to manage multiple complex, time-sensitive licensing applications and compliance obligations simultaneously Outstanding written communication skills: Experience drafting regulatory submissions, applications, policies, and correspondence to regulators Meticulous attention to detail: Strong analytical skills with ability to navigate complex regulatory requirements and ensure accuracy in all submissions Collaborative approach: Commitment to teamwork and ability to work effectively with cross-functional teams and external advisors Bachelor's degree required; JD preferred What helps you stand out: Experience in cross-border payments, FX, or crypto industries Experience with crypto/digital asset licensing (e.g., NY BitLicense, state virtual currency licenses) Experience with international licensing (Canada MSB registration, Latin American licenses) Prior work at a high-growth fintech or payments startup managing rapid licensing expansion Existing relationships with state regulators, CSBS, or Money Transmitter Regulators Association (MTRA) Familiarity with RegTech tools and automation for regulatory compliance and reportin What We Offer Competitive salary and benefits package Impact: Own the licensing function at a critical growth stage and directly enable business expansion Growth: Opportunity to build a function and help scale a successful high-growth company Learning: Opportunity to work in a fast-paced startup at the forefront of fintech innovation. Culture: Collaborative team environment with emphasis on personal and professional growth Mission: Help build the future of global financial infrastructure We are committed to building a diverse and inclusive workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Location: Remote, USAEmployment Type: Full-Time About RadformationRadformation creates solutions that detect medical errors and save clinical time for clinicians, with a focus in radiation therapy. Using advanced algorithms and optimization techniques, our software brings automation to cancer treatment planning and delivery.Currently, many safety checks and planning steps are completed manually. Our goal is to automate these processes to create a more efficient and safer healthcare environment. Our software focuses on three key areas: • Time savings through automation. • Error reduction through automated systems monitoring patient data for errors. • Increased quality of care through advanced algorithms that improve treatment plans compared to current manual methods. We are a fully remote, mission-driven team united by a shared goal: to reduce cancer's global impact and help save more of the 10 million lives it claims each year. Every line of code, every product release, and every conversation with our customers brings us closer to ensuring no patient's treatment quality depends on where they live. Why This Role MattersRadformation is seeking a self-motivated Regulatory Affairs Design Control Specialist to join our innovative team. As Radformation continues to scale, this role will work directly with the VP of Regulatory Affairs to lead, organize, and maintain design control documentation and processes. You will ensure all product deliverables meet internal SOPs and global regulatory standards, supporting Radformation's mission to provide safe and effective software solutions for cancer treatment. Responsibilities Include: • Establish project-specific technical file deliverable lists aligning with internal SOPs, FDA QMSR, and EU MDR. • Utilize appropriate templates for each deliverable, including but not limited to requirements, usability, risk, clinical evaluation, and verification and validation. • Leverage existing content where applicable. • Coordinate deliverables across teams, ensuring owners understand expectations, receive guidance, and that progress is tracked appropriately within eQMS and ALM systems. • Present project deliverables during inspections and internal/external audits. • Analyze performance data and internal processes to identify improvement opportunities. • Assist and support JIRA-ALM integration. • Consult with Product and Development teams to interpret regulatory intent and maintain compliance with evolving design control and technical file expectations. • Assist with international regulatory submissions and applications. • Perform other quality and regulatory-related duties as assigned (e.g., validation of quality and regulatory applications). Required Experience: • 5+ years of Quality Systems experience and Software as a Medical Device (SaMD) experience. • 3+ years in a project management or technical leadership role. • Experience working in a regulated agile development environment. • Familiarity with global medical device regulations: QSR/QMSR, MDD/CMDR/MDR. • Demonstrated understanding of ISO 13485, ISO 14971, IEC 62304, GDPR, HIPAA, and other international regulations/directives/standards. Preferred Experience: • Product development experience highly preferred. • Extensive experience working with various eQMS and ALM applications. • Strong project management skills. • Experience with post-market or adverse event evaluation and reporting. • PMI certification a plus. Who You Are • Clear communicator and believe the team succeeds or fails together. • Highly motivated with strong attention to detail. • Adaptable and thrive in a fast-paced, evolving environment. • You take ownership of your work and have strong prioritization skills. • You have exceptional organizational and interpersonal skills and can manage multiple deliverables simultaneously. • You are comfortable with data analysis, identifying trends, and presenting information clearly. • You are committed to improving patient safety and quality in cancer care. AI & Hiring IntegrityAt Radformation we believe AI can be an incredible tool for innovation, but our hiring process is all about getting to know you, your skills, experience, and unique approach to problem solving. We ask that all interviews and assessments be completed without tools that generate answers in real time. This helps ensure a fair process for everyone and allows us to see your authentic work. Using such tools during the process may affect your candidacy. Benefits & Perks - What Makes Us RADWe care about our people as much as we care about our mission. We offer competitive compensation, benefits, and the opportunity to make an impact in the fight against cancer. The salary range for this role is $140,000 - $170,000 USD base, plus bonus eligibility. Additionally: • Multiple high-quality medical plan options with premiums covered for employees (with subsidized coverage for dependents). • Health coverage starting on day one. • Short-term and long-term disability and supplementary life insurance. • 401(k) with employer match vested immediately. • Annual reimbursement for professional memberships. • Conference attendance and continued learning opportunities. • Self-managed PTO and 10 paid holidays. • Monthly internet stipend and one-time home office setup stipend. • Fully remote work environment with virtual events and yearly retreats. Our Commitment to DiversityCancer affects people from every walk of life, and we believe our team should reflect that diversity. Radformation is proud to be an equal opportunity workplace and an affirmative action employer. We welcome candidates from all backgrounds and are committed to fostering an inclusive environment for all employees. Agency & Candidate Safety NoticeRadformation does not accept unsolicited resumes from agencies without a signed agreement in place. We do not partner with third-party recruiters unless explicitly stated. All legitimate communication from Radformation will come from an @radformation.com email address. If you receive outreach from another domain or via unofficial channels, please contact ************************.We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Regulatory Affairs Group Job Sub Function: Regulatory Affairs Job Category: Professional All Job Posting Locations: Santa Clara, California, United States of America Job Description: Johnson & Johnson is hiring for a Principal Regulatory Affairs Specialist- Shockwave Medical to join our team. The position is FULLY REMOTE and can sit anywhere in the US. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************/. Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that's pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque. The Principal Specialist, Product Stewardship: Serves as the primary liaison between the J&J Product Stewardship team and Shockwave stakeholders (including R&D, Supply Chain, Quality, Regulatory Affairs, Finance, Packaging, Marketing, and others as required) with regards to product stewardship programs, helping to manage business risk and institutionalize product stewardship programs. Supports global Product Stewardship activities associated with the following, and others as required: Global REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) requirements Global Restriction of Hazardous Substances (RoHS) requirements Global Battery Regulations Global Packaging and Packaging Waste Regulations Other applicable environmental regulations under the purview of Product Stewardship Develops systems for intake, assessment, and tracking of worldwide environmental product and packaging compliance requirements. Liaises with new product development teams to ensure product stewardship and environmental sustainability requirements are considered during new product design and launch. Works with appropriate internal and external stakeholders to ensure worldwide reporting obligations related to environmental and packaging requirements are met. Creates and/or updates procedures to reflect changing environmental requirements, ensuring processes support the mining of data necessary to demonstrate compliance. Advises management on trends in the global regulatory environment that may impact current or future Shockwave business. Manages and provides updates on critical tasks for ongoing projects. Develops skill set to enable value-added individual contributions working under moderate supervision. Implements methods for planning, directing, coordinating, and controlling Product Stewardship regulatory affairs activities related to new and modified products worldwide in compliance with corporate policies and strategies. Interprets new and changing government regulations and stewardship guidance to ensure compliance with regulatory/government standards and expectations. Requirements University/Bachelor's degree or equivalent, master's degree preferred, with emphasis on chemistry, engineering, or related sciences At least 8 years experience in Regulatory Affairs, including 3+ years working with environmental sustainability and packaging regulations Familiarity and knowledge of global product stewardship regulations (e.g., REACH, RoHS, Batteries, PPWR, CA Prop 65, WEEE, etc.) Clear and effective verbal and written communication skills with diverse audiences and personnel Ability to think analytically with excellent problem-solving skills Demonstrated ability to strategize, create, implement and execute a program across multiple departments Strong organization and time management skills, including the ability to prioritize multiple challenging project timelines in a fast-paced environment while ensuring collaboration, accuracy, and all deadlines are met Applies Johnson & Johnson's Credo and Leadership Imperatives in day-to-day interactions with internal and external colleagues Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ( ******************************** ) or contact AskGS to be directed to your accommodation resource. The anticipated base pay range for this position is : US : $105,000 - $169,050 / Bay Area : $121,000 - $194,350 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours Additional information can be found through the link below. *********************************************

and Purpose: The Regulatory Affairs Specialist works individually and with a team to request, receive, verify and send documents needed for Regulatory compliance. They regularly work on managing and documenting information and must be adept at working with databases and other information management tools. Essential Functions Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Communicate with internal departments and external departments for document requests Contact vendors for regulatory documentation, review for completeness, and accuracy. Utilize supplier compliance software to upload, download and organize files Create, update, and provide documentation to customers (Technical Data Sheets, compliance documents, etc.) Organize and retrieve necessary documents upon request (physical and digital) Communicates with certification bodies for organic, kosher, BRC, etc. Complete Alcohol and Tobacco Tax Bureau (TTB) drawback and formula submissions Identify and interpret relevant regulatory guidelines Assist internal departments in meeting compliance requirements Ensure ongoing compliance by staying current with relevant regulations and best practices Perform additional duties as assigned Required Skills: Ability to effectively communicate with all colleagues, levels of management, vendors, and customers Detail-oriented with the ability to manage concurrent projects Intermediate understanding of Microsoft Office and applicable standard operating procedures Ability to type 40 words per minute Physical Demands The physical responsibilities described here must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is frequently required to sit, stand, bend, as well as talk and hear. Specific vision abilities required by this job include close vision. Must be able to regularly use hands to handle or feel objects, tools, or controls, reach with hands and arms, and climb stairs. The position requires the ability to occasionally lift, push or pull office products and supplies, up to 25 pounds. Working conditions The position works in an office setting. This role routinely uses standard office equipment such as computers, phones, filing cabinets and fax machines. The noise level in the work environment is moderate. Position Type / Expected Hours of Work This is a full-time position. Standard days and hours of work are Monday through Friday, 8:00am - 4:30pm but may vary based on location. This position is eligible for remote work with potential infrequent travel to our San Clemente, CA or Concord, NC sites. Education and Experience Bachelor degree in Food Science, Chemistry, Flavor Science, or a related field with 2+ years of Regulatory experience in the food/flavor/aroma chemical industry or high school diploma 4+ years of Regulatory experience in a highly regulated food industry required Experience with Organic Certification & Kosher Certification required HACCP Certification and GFSI Certification preferred Experience managing TTB formula submissions or drawback filings strongly preferred The expected pay range for this position is $32.00-$37.00 hourly for candidates residing and/or working in California only. Actual compensation may vary based on location, experience, and qualifications. Candidates residing outside of California may be offered a different range aligned with regional market data.

Spyre Therapeutics is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care for inflammatory bowel disease (“IBD”) and rheumatic diseases. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23. Role Summary: The Regulatory Document Coordinator will have primary responsibility for document management activities supporting Regulatory Affairs within Spyre. Key responsibilities include word formatting, PDF publishing, eCTD output review, submission archival, and document workflow management, along with other assigned tasks. , including word formatting, PDF publishing, eCTD output review, submission archival, document workflow management, and other activities, as assigned. This role position will play an integral role in the execution of the Regulatory strategy world-wide, with multiple avenues for continued development within the Regulatory Operations function. Key Responsibilities: Document Level Responsibilities: Provide ongoing Word formatting support and final formatting for internally authored documents intended for submission. Perform final PDF publishing for all submission documents. Ensure that all final electronic deliverables meet current regulatory electronic document requirements. Assess publishing and formatting needs and communicate impacts to overall project timelines. Assist in managing the activities of external publishing staff contracted to publish and dispatch health authority submissions. Manage document-related tasks including internal workflow management, file transfer, tracking, and archival. Communicate and provide deliverables to Medical Writers, Quality, Regulatory Leads and others as applicable. Initiate preliminary drafts of documents for team authoring activities, as needed. Submission Level Responsibilities: Manage submission archival for ongoing regulatory submissions. Maintain and update trackers, correspondence logs, and metrics, as needed, to support the Regulatory Team. File Regulatory correspondence in the Regulatory Information Management (RIM) system. Collaborate with cross-functional teams to ensure regulatory compliance and submission timelines. Infrastructure Level Responsibilities: Assist in Veeva RIM management activities. Serve as the internal subject matter expert (SME) for Accenture Formatting Tool, as a resource for Regulatory and cross-functional authoring teams. Assist in maintaining regulatory document template library. Lead training sessions on submission formatting, new systems and tools, etc. Ideal Candidate: Bachelor's degree with a minimum of 3-5+ years of experience in a Regulatory Operations environment within the pharmaceutical industry, preferably with a focus on eCTD dossier management. In lieu of a degree, 6+ years of relevant industry experience is required. Proven experience managing multiple active regulatory applications simultaneously. Advanced proficiency with Microsoft Office Suite and Adobe. Demonstrates adaptability, a strong willingness to learn new skills, and a collaborative approach to supporting team initiatives. Experience with Veeva RIM systems and SharePoint a plus. Attention to detail, and excellent organizational and prioritization skills. Motivated to work in a fast-paced, high-accountability environment. Excellent communication and interpersonal skills, with the ability to motivate teams and collaborate effectively across functions. What We Offer: Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly. Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits. Unlimited PTO Two, one-week company-wide shutdowns each year. Commitment to provide professional development opportunities. Remote working environment with frequent in-person meetings to address complex problems and build relationships. The expected salary range offered for this role is $95,000 to $122,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location. As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing life-changing products for patients. Spyre Therapeutics, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Please be aware that official recruiters at Spyre Therapeutics only use email addresses with the domain “@spyre.com.” We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email. Please also be aware that all job postings will be listed on our website at spyre.com/careers/.

Job Title: Regulatory Affairs SpecialistJob Description We are seeking a full-time Clinical Research & Regulatory Affairs Specialist to work remotely for at least six months, dedicated to the oncology research program. This role involves preparing and processing all regulatory documentation through IRB/CIRB, including new submissions, continuing reviews, amendments, adverse events, and reportable events, with minimal supervision. The specialist will also handle regulatory documentation for the NCI, organize and maintain all regulatory affairs documentation/files, resolve regulatory and data queries, and participate in monitoring, audit, and close-out visits as needed. Participation in study team meetings, research team meetings, and ongoing protocol training/compliance meetings is expected. Responsibilities * Review, reconcile, and ensure compliance for an NCTN trial previously initiated under prior leadership. * Manage a large volume of data entry, query resolution, images for upload, and regulatory submissions to maintain regulatory compliance. * Submit final termination requests through CIRB for studies no longer active at the site. * Prepare and process regulatory documentation for IRB/CIRB, including new submissions, continuing reviews, amendments, adverse events, and reportable events. * Organize and maintain regulatory affairs documentation/files as required. * Resolve regulatory and data queries. * Participate in monitoring, audit, and close-out visits. * Attend study team meetings, research team meetings, and ongoing protocol training/compliance meetings. Essential Skills * Regulatory Affairs expertise. * Active NCI RCR registration. * Experience managing high-risk NCTN biomedical research. * Advanced knowledge and ability to work within CTEP portal, RUMS rostering, OPEN/Rave database, and CIRB Manager. Additional Skills & Qualifications * BS degree, preferably in a life science or human subject protection field. * 3-5 years of research experience. * At least 1 year of regulatory experience preferred. Work Environment This position is fully remote, allowing for flexible work arrangements from any location. The role is contingent on funding, with six months of funding secured and additional opportunities being explored. Job Type & Location This is a Contract position based out of Philadelphia, PA. Pay and Benefits The pay range for this position is $40.00 - $45.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully remote position. Application Deadline This position is anticipated to close on Dec 25, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

SI-BONE is a fast-growing, publicly traded medical device company that is an industry pioneer in minimally invasive sacropelvic solutions. Our mission is to help patients rise up and reach for the stars, and our vision is to work together as the global leader to make sacropelvic conditions universally recognized and effectively treated through innovation, evidence, education, and advocacy. Santa Clara, CA (4 days in-office required. Not a remote role) SI-BONE is focused on helping patients in one of the most under-served, under-diagnosed, and under-treated areas in orthopedics, the sacroiliac (SI) joint. SI-BONE developed an innovative, patented implant to fuse the SI joint. The iFuse Implant System provides a less invasive alternative to traditional sacroiliac (SI) joint fusion surgery and has been used in over 90,000 procedures to date. We are a medical device company that is focused on improving the lives of patients with sacroiliac pelvic conditions. We are looking for people who are passionate about our mission and who are willing to work hard to achieve it. We are also looking for people who are: Agile: We work in a fast-paced environment and need to be able to learn and adapt to change quickly. Creative: We embrace creativity, and we need people who are not afraid to challenge the status quo. Team Players: We roll-up our sleeves and work together as one team to achieve our goals. General Responsibilities: Prepare regulatory submissions to support product commercialization (e.g. 510(k), CE Mark Technical File, International). Maintain existing approvals/clearances and documentation. Manage projects to compliment key strategic and commercial initiatives. In the event of potential non-compliance with applicable standards or regulations (e.g. FDA QSRs, ISO 13485, ISO 14971, IEC 62366), the employee has the authority to hold any product or QA/RA documentation from shipment or further processing. The employee has the responsibility to report any instances to their direct supervisor or above. The employee must at all times act and conduct business in an honest, ethical and strictly legal manner, complying with the Code of Conduct, other company policies, the AdvaMed Code and all applicable laws and regulations, whether national, regional, state or local. Specific Responsibilities and Skills: Support New Product Development on project teams on behalf of RA, developing and implementing Regulatory strategies and deliverables for US, EU and International (OUS) In conjunction with Head of Regulatory, responsible for communication and correspondence with EU Notified Body, FDA, and other Regulatory bodies (competent authorities) Prepare Regulatory submissions such as US Pre-submissions, 510(k)s and Letter-to-File; and EU / OUS Declarations of Conformity, Technical Files (STEDs), Notice of Changes for new products and product changes Review product changes for impact on current clearances and approvals Implement new regulations and changes to US and global Regulatory requirements (e.g. EU MDR) Attend internal and external audits/inspections in a Regulatory capacity and address any issues or concerns, and support the Quality System Management Representative, as appropriate Facilitate communication, Regulatory-related remediations, and written audit responses to the responsible Regulatory agency Oversee labeling, including product labels, implant cards, IFUs, surgical technique manuals, cleaning and sterilization instructions, etc., ensuring compliance to standards, guidelines, regulations, company requirements, and regulatory approvals/clearances. Ensures translations have been performed per in country requirements. Communicate with RA consultants (e.g. Emergo), Authorized Representative and sometimes directly with International regulatory bodies (competent authorities) to obtain approvals and manage registrations Monitor and obtain information regarding FDA clearances/approvals of competitors and proactively share information Support Regulatory-related activities for Sustaining Operations, including product changes, supplier changes, CAPAs, Deviations, NMRs, and extension/scope changes Write and/or review SOPs, WIs, Forms that impact the QMS Support SI-BONE QMS Knowledge, Education and Experience: Bachelor's degree in a scientific discipline 6+ years of directly relevant experience with a minimum of 5 years of recent experience in medical devices/ FDA/cGMP/CE Mark or other regulated environment(s). Knowledge of industry standards and regulations (FDA, QSRs, MDR ISO 13485, MEDDEV, MDCG etc.) Experienced in Quality System requirements such as Design Control, Production Process Controls, Supplier Controls, Corrective and Preventive Action, and Non-Conformances Strong oral, written, organizational and computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel) and Adobe Acrobat (for FDA E-copies) Thorough understanding of FDA and international medical device regulations, product development process and design control requirements Ability to work independently with minimal supervision and manage multiple projects Must be a team player Please note that this is not a remote role. Candidates must reside in the SF Bay Area. Salary range: $129,000 - $147,000. The compensation range for this position is specific to the location and is in good faith what SI-BONE expects to pay for the position taking into account the wide variety of factors that are considered in making compensation decisions, including job-related knowledge; skillset; experience, education and training; certifications; and other relevant business and organizational factors. Supplemental pay: bonus and stock There are potential risks associated with the iFuse Implant System. It may not be appropriate for all patients and all patients may not benefit. For additional information on the company or the products including risks and benefits, please visit ********************** We are aware of active recruitment scams using the SI-BONE name, in which individuals pose as our recruiters and post fake remote job openings and make fake job offers on the Internet. Please note, we will never make an offer of employment without conducting multiple rounds of interviews face-to-face using secure video-conferencing technology. We will never ask candidates to cash checks or make a payment in order to be considered for a position. SI-BONE only uses company email addresses, which contain “@si-bone.com” to communicate with candidates. If you believe you've been a victim of a phishing scam, please visit the Cybersecurity & Infrastructure Security Agency at *************************************************** learn how to report it.

At Anchorage Digital, we are building the world's most advanced digital asset platform for institutions to participate in crypto. Anchorage Digital is a crypto platform that enables institutions to participate in digital assets through custody, staking, trading, governance, settlement, and the industry's leading security infrastructure. Home to Anchorage Digital Bank N.A., the only federally chartered crypto bank in the U.S., Anchorage Digital also serves institutions through Anchorage Digital Singapore, Porto by Anchorage Digital, and other offerings. The company is funded by leading institutions including Andreessen Horowitz, GIC, Goldman Sachs, KKR, and Visa, with its Series D valuation over $3 billion. Founded in 2017 in San Francisco, California, Anchorage Digital has offices in New York, New York; Porto, Portugal; Singapore; and Sioux Falls, South Dakota. Learn more at anchorage.com, on X @Anchorage, and on LinkedIn. We are building a regulated infrastructure platform at the intersection of banking, markets, and digital asset ecosystems. The Global Analytics Team delivers quantitative, policy, and data-driven capabilities that empower business units to scale, govern, and satisfy supervisory expectations. We are seeking a highly motivated and analytical individual to join our Economic & Regulatory Analysis pillar, focused on capital, margin, liquidity, and supervisory readiness across banking and markets regimes. We have created the Factors of Growth & Impact to help Villagers better measure impact and articulate coaching, feedback, and the rich and rewarding learning that happens while exploring, developing, and mastering the capabilities and contributions within and outside of the Member of Global Analytics role:Technical Skills: Foundational capability in regulatory analysis across banking and markets frameworks, including ability to interpret statutes, rules, supervisory guidance, and industry standards. Familiarity with capital, liquidity and margin frameworks (e.g., initial margin, variation margin, netting, collateral eligibility). Understanding of risk measurement methods (e.g., stress testing, scenario analysis, backtesting) and regulatory capital concepts. Experience handling large datasets, applying statistical or econometric tools (e.g., Python, R) , conducting research and data analysis (e.g., SQL). Complexity and Impact of Work: Translate evolving banking and market regulations into actionable analytics, policy, and operational road-maps with limited supervision. Assist in the development and maintenance of capital, margin and liquidity methodologies aligned to regulatory expectations. Apply analytical rigor to capital, liquidity, and margin concepts; supports impact assessments and structured risk/capital analyses. Support licensing submissions, supervisory engagements, internal governance and business decision-making. Build repeatable frameworks and artifacts across regulatory, capital and margin domains, enabling the institution to scale and meet supervisory scrutiny. Organizational Knowledge: Has a deep knowledge of the strategy of Anchorage Digital and its various business lines. Understands how regulatory, capital, liquidity, and control expectations intersect with business model, product architecture, and operating processes. Builds working knowledge across Legal, Risk, Finance, Operations, and Product to translate requirements into scalable controls and workflows. Recognizes governance touchpoints, internal approval pathways, and key decision forums; ensures materials reflect decision-grade clarity. Communication and Influence: Demonstrates capability in writing, editing, and reviewing technical documents suitable for various contexts (e.g., regulatory or banking, internal or external stakeholders). Synthesizes complex regulatory concepts into concise, decision-ready narratives for senior stakeholders. Collaborates across teams, contributes to cross-functional initiatives, and guides colleagues or stakeholders in technical topics. Influences decision-making through structured recommendations, escalation of risk points, and disciplined documentation. You may be a fit for this role if you have: A bachelor's degree in economics, finance, public policy, or related field; advanced degree preferred. 3-5+ years in financial services, regulatory advisory, risk/capital functions, or regulatory agency. Familiarity with prudential standards (OCC/FRB) and derivatives/market frameworks (CFTC/SEC), and practical exposure to regulatory capital, margin frameworks, banking or derivatives markets. Strong analytical skills, including ability to handle large datasets and apply statistical or econometric tools. Exceptional written and verbal communication skills; able to distill complex concepts into actionable insights. High analytical rigor, cross-functional execution discipline, and attention to detail. Although not a requirement, bonus points if: You've kept up to date with the proliferation of blockchain and crypto innovations. You were emotionally moved by the soundtrack to Hamilton, which chronicles the founding of a new financial system. :) About Anchorage Digital: Who we are The Anchorage Village, what we call our team, brings together the brightest minds from platform security, financial services, and distributed ledger technology to provide the building blocks that empower institutions to safely participate in the evolving digital asset ecosystem. As a diverse team of more than 300 members, we are united in one common goal: building the future of finance by providing the foundation upon which value moves safely in the new global economy. Anchorage Digital is committed to being a welcoming and inclusive workplace for everyone, and we are intentional about making sure people feel respected, supported, and connected at work-regardless of who you are or where you come from. We value and celebrate our differences and we believe being open about who we are allows us to do the best work of our lives. Anchorage Digital is an Equal Opportunity Employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or veteran status. Anchorage Digital considers qualified applicants regardless of criminal histories, consistent with other legal requirements. “Anchorage Digital” refers to services that are offered either through Anchorage Digital Bank National Association, an OCC-chartered national trust bank, or Anchorage Lending CA, LLC a finance lender licensed by the California Department of Financial Protection and Innovation, License No. 60DBO-11976, or Anchorage Digital Singapore Pte Ltd, a Singapore private limited company, all wholly-owned subsidiaries of Anchor Labs, Inc., a Delaware corporation. Protecting your privacy rights is important to Anchorage Digital, and we work to maintain the trust and confidence of our clients when handling personal or financial information. Please see our privacy policy notices here.

Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases. Stay Connected with Telix for Future or Upcoming Regulatory Affairs - CMC Opportunities Telix is always looking to connect with great talent in the market! While we may not have the position you're looking for open today, we'd love for you to share your information with us for future openings. This post is not for a specific role or territory, but we can reach out when an opening comes available. See Yourself at Telix The Global Regulatory CMC team is responsible for authoring/writing CMC specific regulatory dossiers (3.2.S and 3.2.P sections) towards the development and commercialization of radiopharmaceutical and biopharmaceutical products. This role requires good understanding of technical (Quality/CMC) regulatory requirements, and an equally important ability to write technical Module 3 dossiers. This team will develop ICH aligned CMC/Technical portions of global regulatory submissions that are high-quality, fit for purpose, and prepared in a timely manner across for early to late stage and post-approval programs. Key Accountabilities Regulatory Submissions: Plan, prepare/revise eCTD Module 2.3 & Module 3 documents for INDs, IMPDQs, NDAs, BLAs, MAAs, CTAs, post-approval supplements and variation submissions, ensuring accuracy and completeness. Documentation and Systems: Ensure Module 3 documentation is planned, tracked, clearly written, with the use of regulatory domain systems (Veeva) and processes. Regulatory Compliance and Intelligence: Stay current and interpret evolving CMC regulatory requirements and guidelines such as ICH, US FDA CFRs, EMA Directives and Annexes. Ensure CMC documentation and data are compliant with regulations. Cross-Functional Collaboration: Collaborate with internal stakeholders, including Quality Assurance, CMC/Manufacturing, and preclinical teams for planning and authoring of CMC regulatory scope and content. Change Management: Provide regulatory assessments for manufacturing changes, including site transfers, scale-up activities, and process changes. Conduct comparability assessments and develop post-approval supplements as needed. Education and Experience Undergraduate degree required; Advanced degree (M.Sc., Ph.D.) with a focus in Biological Sciences, Engineering or a related field preferred. Experience with a strong focus on CMC in the radiopharmaceutical or biopharmaceutical industry. Regulatory Knowledge: Solid understanding of global regulatory requirements and guidelines for CMC, including ICH guidelines and FDA, EMA, and other health authority regulations. Communication Skills: Excellent technical writing and verbal communication skills, with the ability to effectively communicate complex regulatory issues to internal and external stakeholders. Analytical Skills: Good analytical and problem-solving skills, with the ability to assess and mitigate regulatory risks. Interpersonal Skills: Ability to work collaboratively and build effective relationships across functions and geographies. Technical Writing: Skilled at summarizing pharmaceutical manufacturing and method development reports, data into appropriate sub-sections of Module 3. Interested in joining our mission? Submit your information and let's stay connected! At Telix, we believe everyone counts, we strive to be extraordinary, and we pursue our goals with determination and integrity. You will be part of an engaged and supportive group of colleagues who all have a shared purpose: to help people with cancer and rare diseases live longer, better quality lives. Being a Telix employee means being a part of a unique, global, interdisciplinary team working to deliver what's next in precision medicine. We have hybrid and remote employees located all around the world. We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development. Telix Pharmaceuticals is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics. VIEW OUR PRIVACY POLICY HERE

Cordance is dedicated to accelerating the growth of vertically focused business-to-business (B2B) software-as-a-service (SaaS) companies through acquisition and long-term tactical and financial guidance. We're experienced operators and subject-matter experts with a passion for software and building businesses. We partner with founders to help them scale their businesses and realize their companies' full potential. We look for businesses with strong leadership and high potential for profitable growth, and work together to increase year-over-year revenue, company efficiency, and impact. Cordance envisions that all companies we work with achieve their full potential. We embrace what makes each company great and build on those foundations. We believe in elevating a company as it scales, delivering dignity to the organization and its employees, and sharing a passion for building a legacy. Ithos Global is an information management company and regulatory compliance leader in helping cosmetic, personal care, and OTC companies meet their global product compliance standards Based on specific client needs related to regulatory compliance, Ithos uses state-of-the-art technology to deliver its services and tools. As a rapidly growing business, Ithos is in search of a Senior Regulatory Affairs Specialist to meet the demands of this marketplace. We are looking for individuals who possess a strong attention to detail and recognition of issues, someone who is highly motivated, and has a positive attitude to add to our Regulatory Team. Location This position is fully remote with an occasional need for business travel. Responsibilities As an Ithos Global Regulatory Affairs Senior Specialist, you will be responsible to support and advise on a vast array of end-to-end Regulatory Affairs topics for the product categories of Cosmetics, Personal Care, Consumer Products, and OTCs. Some role activities will also fall under the areas of the knowledge and use of Ithos Information Network (IIN) System: Various Regulatory Tasks and the Management of them including: Documentation and review, global formula compliance screenings, ingredient policies, Ingredient Listings, global registrations and notifications, and Safety Data Sheet authoring Label, claims, and testing protocol reviews Ownership of client relationships and projects Training of employees Research of regulations and related information Trade council engagement Projects may also be assigned with an expectation of project management and leadership which will relate to Team and Company objectives Additional Expectations This role has added expectations for leadership in the areas of project deliverables and client relationships as well as process improvements and a call to action on issues. An established point of view on topics of regulatory risk, software enhancements, project leadership, and the global regulatory landscape and surveillance is also necessary. This role acts independently to provide client advisement and deliverables with the support of other team associates. Technical knowledge and research ability skills should be developed and utilized as a resource for the company and Team. Qualifications College graduate with degree in related field of biological sciences, chemistry, physics, cosmetic science, political science 5-10 years of experience in Cosmetic and Personal Care Regulatory Affairs Experience with the use of compliance software, integration, and regulation content management Please note that we do not accept unsolicited resumes, work on a Corp-to-Corp basis, or engage with non-vetted external agencies. Why Join Us? At Cordance, we believe in taking care of our team members. When you join us, you'll enjoy a comprehensive benefits package designed to support your health, financial well-being, and work-life balance: Health and Wellness: Comprehensive Health Coverage: Coverage begins on your first day of employment. Retirement Savings: 401K Plan (US): We match 1:1 for the first 3% of contributions and 0.5:1 for the next 2%. Contribute 5% of your salary and get a 4% match. Choose from pre-tax and Roth options. You're eligible the first of the month after 90 days and immediately vested. RRSP (CAN): We match 1:1 for the first 3% of contributions and 0.5:1 for the next 2%. Contribute 5% of your salary and get a 4% match. Choose from pre-tax and Roth options. You're eligible the first of the month after 90 days and immediately vested. Paid Time Off: Flexible PTO: Enjoy uncapped paid time off to balance your work and personal life. Parental Leave: 12 weeks paid leave for all employees. Remote Work Support: Monthly Stipend: Receive $75 USD / $140 CAD per month for phone and internet if you work remotely. Holidays: Generous Holiday Schedule: Benefit from an extensive list of holidays to recharge and spend time with loved ones. Join us and be part of a company that values your contributions and well-being from day one! EEOC & ADA Statement : Cordance and its companies provide equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, creed, sex, nationality, ancestry, national origin, disability status, genetics, protected veteran status, affectional or sexual orientation, gender identity or expression, marital status, or any other characteristic protected by federal, state, or local laws. Cordance and its companies comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact Human Resources. This applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. Final candidate must be able to pass a background check. To view applicant notices required under federal and state law, please visit: **************************************

Exceed the expectations of our residential mortgage borrowers & business partners through superior service, simple processes, and effective communications. We deliver on this mission by empowering our employees by encouraging and recognizing superior performance and innovative solutions, by promoting teamwork and divisional cooperation. Primary Function This position plays a critical role in the success of Newrez by managing the end-to-end process associated with examinations. The Exam Coordinator III facilitates the exam management process, which includes interaction with all levels of management and departments across the organization as well as regulators. Principal Duties List of required duties below. Distinguish on-site duties with a *. Responsible for the project management functions related to managing all regulatory and third-party client exams. Primary focus is high-profile exams such as Freddie, Fannie, Ginnie Mae, FHA, VA, etc. Must also be able to facilitate State/Client/Joint Venture exams. Prepare exam decks per examiners' agenda requirements. Delegate tasks to other team members as applicable to meet deadlines. Provide assistance with new hire training of dept. functions. Primary contact with regulatory agencies and clients for all external exams. Including timely follow-ups on examiners' requests. Work directly with all levels of management throughout the organization to gather evidence related to exam requests. Coordinate onsite and remote examiner requests for information. Responsible for escalating any regulator concerns, emerging themes, or issues and driving action. Partner with Training for exam preparation business units for interacting with regulators. Perform root cause analysis on exam findings and work with appropriate business units on corrective action plans. Assist in the drafting of audit finding responses to regulators as required. Schedule/Facilitate meetings with regulators via Teams, Skype, Outlook, and onsite schedules. Provide assistance with regulatory reporting, including MBFRF, MCRs and other required reporting to state regulatory agencies. Provide assistance with weekly updates to compliance for deck presentations. Exam status reporting to management for dept. Maintain current daily exam status logs. Performs related duties as assigned by management. *These essential functions are fundamental to the role, and must be performed on-site, as they cannot physically be performed remotely. In addition, the Company has determined that an in-person presence is important to critical components of our work, including oversight, training, collaboration, and productivity. Items not marked (*) as essential on-site, may still require partial on-site work to perform the role satisfactorily. Education and Experience Requirements High school diploma or equivalent, required. 5+ years of experience, or combination of Compliance, Mortgage Servicing, Default Servicing, Debt Collections. IT Audit experience preferred. Experience in developing and delivering presentations to senior management. Experience in process definition and control definitions based on industry best practices. Knowledge, Skill, and Ability Requirements Ability to multi-task as well as quickly adapt to changing work assignments. Knowledge of credit reporting and FCRA is a plus. Math and analytical skills needed. Ability to develop new, and maintain existing, business relationships in a complex cross-organizational and cross-functional matrix environment with both internal and external stakeholders) Working knowledge of risk management. Familiarity with Mortgage Servicing systems is preferred. Excellent work ethic and deadline driven. Follow up skills and a strong sense of accountability. Must possess a short learning curve related to assimilation of new skills and tasks. Superior organizational skills needed. While this description is intended to be an accurate reflection of the position's requirements, it in no way implies/states that these are the only job responsibilities. Management reserves the right to modify, add or remove duties and request other duties, as necessary. By applying to this position candidate acknowledges that this is not a remote role and is required to be on-site. Additional Information: While this description is intended to be an accurate reflection of the position's requirements, it in no way implies/states that these are the only job responsibilities. Management reserves the right to modify, add or remove duties and request other duties, as necessary. All employees are required to have smart phones that meet Company security standards with the ability to install apps such as Okta Verify and Microsoft Authenticator. Employment will be contingent on this requirement. Company Benefits: Newrez is a great place to work but we are only as strong as our greatest asset, our employees, so we believe in rewarding them! Medical, dental, and vision insurance Health Savings Account with employer contribution 401(k) Retirement plan with employer match Paid Maternity Leave/Parental Bonding Leave Pet insurance Adoption Assistance Tuition reimbursement Employee Loan Program The Newrez Employee Emergency and Disaster Fund is a new program to support our team members Newrez NOW: Our Corporate Social Responsibility program, Newrez NOW, empowers employees to become leaders in their communities through a robust program that includes volunteering, philanthropy, nonprofit grants, and more 1 Volunteer Time Off (VTO) day, company-paid volunteer day where all eligible employees may participate in a volunteer event with a nonprofit of their choice Employee Matching Gifts Program: We will match monetary employee donations to eligible non-profit organizations, dollar-for-dollar, up to $1,000 per employee Newrez Grants Program: Newrez hosts a giving portal where we provide employees an abundance of resources to search for an opportunity to donate their time or monetary contributions Equal Employment Opportunity We're proud to be an equal opportunity employer- and celebrate our employees' differences, including race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, and Veteran status. Different makes us better. CA Privacy Policy CA Notice at Collection

Exceed the expectations of our residential mortgage borrowers & business partners through superior service, simple processes, and effective communications. We deliver on this mission by empowering our employees by encouraging and recognizing superior performance and innovative solutions, by promoting teamwork and divisional cooperation. Primary Function This position plays a critical role in the success of Newrez by managing the end-to-end process associated with examinations. The Exam Coordinator III facilitates the exam management process, which includes interaction with all levels of management and departments across the organization as well as regulators. Principal Duties List of required duties below. Distinguish on-site duties with a *. * Responsible for the project management functions related to managing all regulatory and third-party client exams. * Primary focus is high-profile exams such as Freddie, Fannie, Ginnie Mae, FHA, VA, etc. * Must also be able to facilitate State/Client/Joint Venture exams. * Prepare exam decks per examiners' agenda requirements. * Delegate tasks to other team members as applicable to meet deadlines. * Provide assistance with new hire training of dept. functions. * Primary contact with regulatory agencies and clients for all external exams. Including timely follow-ups on examiners' requests. * Work directly with all levels of management throughout the organization to gather evidence related to exam requests. * Coordinate onsite and remote examiner requests for information. * Responsible for escalating any regulator concerns, emerging themes, or issues and driving action. * Partner with Training for exam preparation business units for interacting with regulators. * Perform root cause analysis on exam findings and work with appropriate business units on corrective action plans. * Assist in the drafting of audit finding responses to regulators as required. * Schedule/Facilitate meetings with regulators via Teams, Skype, Outlook, and onsite schedules. * Provide assistance with regulatory reporting, including MBFRF, MCRs and other required reporting to state regulatory agencies. * Provide assistance with weekly updates to compliance for deck presentations. * Exam status reporting to management for dept. * Maintain current daily exam status logs. * Performs related duties as assigned by management. * These essential functions are fundamental to the role, and must be performed on-site, as they cannot physically be performed remotely. In addition, the Company has determined that an in-person presence is important to critical components of our work, including oversight, training, collaboration, and productivity. Items not marked (*) as essential on-site, may still require partial on-site work to perform the role satisfactorily. Education and Experience Requirements * High school diploma or equivalent, required. * 5+ years of experience, or combination of Compliance, Mortgage Servicing, Default Servicing, Debt Collections. IT Audit experience preferred. * Experience in developing and delivering presentations to senior management. * Experience in process definition and control definitions based on industry best practices. Knowledge, Skill, and Ability Requirements * Ability to multi-task as well as quickly adapt to changing work assignments. * Knowledge of credit reporting and FCRA is a plus. * Math and analytical skills needed. * Ability to develop new, and maintain existing, business relationships in a complex cross-organizational and cross-functional matrix environment with both internal and external stakeholders) * Working knowledge of risk management. * Familiarity with Mortgage Servicing systems is preferred. * Excellent work ethic and deadline driven. * Follow up skills and a strong sense of accountability. * Must possess a short learning curve related to assimilation of new skills and tasks. * Superior organizational skills needed. While this description is intended to be an accurate reflection of the position's requirements, it in no way implies/states that these are the only job responsibilities. Management reserves the right to modify, add or remove duties and request other duties, as necessary. By applying to this position candidate acknowledges that this is not a remote role and is required to be on-site. Additional Information: While this description is intended to be an accurate reflection of the position's requirements, it in no way implies/states that these are the only job responsibilities. Management reserves the right to modify, add or remove duties and request other duties, as necessary. All employees are required to have smart phones that meet Company security standards with the ability to install apps such as Okta Verify and Microsoft Authenticator. Employment will be contingent on this requirement. Company Benefits: Newrez is a great place to work but we are only as strong as our greatest asset, our employees, so we believe in rewarding them! * Medical, dental, and vision insurance * Health Savings Account with employer contribution * 401(k) Retirement plan with employer match * Paid Maternity Leave/Parental Bonding Leave * Pet insurance * Adoption Assistance * Tuition reimbursement * Employee Loan Program * The Newrez Employee Emergency and Disaster Fund is a new program to support our team members Newrez NOW: * Our Corporate Social Responsibility program, Newrez NOW, empowers employees to become leaders in their communities through a robust program that includes volunteering, philanthropy, nonprofit grants, and more * 1 Volunteer Time Off (VTO) day, company-paid volunteer day where all eligible employees may participate in a volunteer event with a nonprofit of their choice * Employee Matching Gifts Program: We will match monetary employee donations to eligible non-profit organizations, dollar-for-dollar, up to $1,000 per employee * Newrez Grants Program: Newrez hosts a giving portal where we provide employees an abundance of resources to search for an opportunity to donate their time or monetary contributions Equal Employment Opportunity We're proud to be an equal opportunity employer- and celebrate our employees' differences, including race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, and Veteran status. Different makes us better. CA Privacy Policy CA Notice at Collection

Who is USP? The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's leading health and science experts to develop rigorous quality standards for medicines, dietary supplements, and food ingredients. At USP, we believe that scientific excellence is driven by a commitment to fairness, integrity, and global collaboration. This belief is embedded in our core value of Passion for Quality and is demonstrated through the contributions of more than 1,300 professionals across twenty global locations, working to strengthen the supply of safe, high-quality medicines worldwide. At USP, we value inclusive scientific collaboration and recognize that attracting diverse expertise strengthens our ability to develop trusted public health standards. We foster an organizational culture that supports equitable access to mentorship, professional development, and leadership opportunities. Our partnerships, standards, and research reflect our belief that ensuring broad participation in scientific leadership results in stronger, more impactful outcomes for global health. USP is proud to be an equal employment opportunity employer (EEOE) and is committed to ensuring fair, merit-based selection processes that enable the best scientific minds-regardless of background-to contribute to advancing public health solutions worldwide. We provide reasonable accommodations to individuals with disabilities and uphold policies that create an inclusive and collaborative work environment. Remote employees must reside in one of the following states: MD, VA, DC, PA, WV, CA, MI, IL, KS, FL, NC, or MN. Brief Job Overview The Associate Hazard Communication Regulatory Compliance Specialist is an entry level position in USP's Hazard Communication Program (HCP), responsible for assisting in the preparation of Safety Data Sheets (SDS), hazard labels, and compliance with the Occupational Safety and Health Administration (OSHA) Hazard Communication Standard. How will YOU create impact here at USP? As part of our mission to advance scientific rigor and public health standards, you will play a vital role in increasing global access to high-quality medicines through public standards and related programs. USP prioritizes scientific integrity, regulatory excellence, and evidence-based decision-making to ensure health systems worldwide can rely on strong, tested, and globally relevant quality standards. Additionally, USP's People and Culture division, in partnership with the Equity Office, invests in leadership and workforce development to equip all employees with the skills to create high-performing, inclusive teams. This includes training in equitable management practices and tools to promote engaged, collaborative, and results-driven work environments. The Associate Hazard Communication Regulatory Compliance Specialist has the following responsibilities: [60 %] Under the supervision of senior staff, research toxicological, chemical, and physical properties of USP chemical products to determine acute and chronic human health hazards, physical hazards relating to fire and accidental release, and hazards to the environment and create safety data sheets and labels. [40 %] Provide Handling Categories, potency evaluations, and any other requested safety information to USP staff and customers as required by law and as requested. Who is USP Looking For? The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience: Bachelor's degree in chemistry or sciences-related discipline. Excellent written and oral communication skills, especially the ability to communicate in a fast-paced, time-sensitive team environment. Ability to research, think critically, analyze conflicting data, and evaluate information sources. Highly organized with excellent attention to detail and able to work independently as well as an effective team member. Proficiency in computer applications (MS Word, Excel) and database experience. Additional Desired Preferences Knowledge of toxicology, industrial hygiene, hazard and risk communication, and chemical regulation. Supervisory Responsibilities None, this is an individual contributor role. Benefits USP provides the benefits to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial well-being is protected. Compensation Base Hourly Range: USD $32.97 - $41.85 per hour. Target Annual Bonus: % Varies based on level of role. Individual compensation packages are based on various factors unique to each candidate's skill set, experience, qualifications, equity, and other job-related reasons. Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.

About Us: Each of CenExel's research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success. Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k. THIS IS NOT A REMOTE POSITION Job Summary: With moderate oversight the Regulatory Coordinator I is responsible for the preparation, organization and implementation of regulatory research documents such as pre-study activities, initiation, execution, and reporting on the various status of research tasks in accordance with FDA guidelines, ICH GCP and SOPs. Maintain regulatory documents in accordance with applicable regulations and coordinate required investigator and study staff training. Schedule: Monday - Friday 08:00 am - 4:30 pm Hourly Range: $29.00 - $35.00/hr (Depending on education, experience, and skillset) Essential Responsibilities and Duties: Collects, prepares, and submits documentation to various sponsors/CROs during study start-up, including: Submission documents/approval, Protocol amendments with respective signature pages, Informed consent documents, FDA form 1572, Lab normal result documents, financial disclosure forms, Delegation of authority logs, Licenses, Reports. Logs (e.g., temperature logs, drug accountability logs, master subject logs, screening and enrollment logs, specimen logs, etc.) Collects, prepares, and submits documentation to institutional review boards for all ongoing and new trials. Serve as a liaison between the IRB, site, and investigator. Obtain necessary signatures from investigators and staff. Maintains and tracks current staff credentials (i.e., CV, certifications, etc.) Maintains and distributes new and revised regulatory documents to applicable site staff and applicable corporate teams. Refers necessary regulatory questions to Sr. Regulatory Coordinator, Regulatory Manager or Regional Regulatory Manager. Maintains regulatory documents for ongoing trials, and ensures all appropriate regulatory documents are archived at the conclusion of the study. Submits applicable subject facing documents for translations. Maintains current Clinical Conductor Regulatory information. Prepares appropriate reports for submission as required to the IRB including Serious Adverse Events (SAE's), protocol deviations and other required reports. Completes onboarding of new Investigators, including CV creation, obtaining medical license, and training documents. Ensures the regulatory binder is ready for monitor review during monitor visits. Meets with monitor, as necessary. Assists with regulatory inspections and sponsor audits as necessary. Performs close-out duties including preparing the final report to the IRB and ensuring all original documents are filed in the regulatory binder. Ensures all appropriate regulatory documents are archived at the conclusion of the study. Supports and ensures strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site working Practices, protocol, and company guidelines and policies. Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive. Education/Experience/Skills: Must be a high school graduate or have GED equivalency. 1+ years of regulatory experience in clinical research required Demonstrated prioritization and organizational skills to efficiently and effectively, providing accurate information in a timely manner. Ability to prioritize workload to meet demands of PI, coordinators, sponsors, and IRBs. Ability to prioritize workload to meet demands of PI, coordinators, sponsors, and IRBs. Demonstrated interpersonal skills to work with physicians, administrators, work colleagues, representatives from sponsors and others to achieve maximum efficiency in reaching and maintaining workplace goals in a professional manner. Ability to understand work may be delegated by more than one person, depending on the individual needs of the clinical study and to carry out job responsibilities as assigned in a timely manner. Computer skills using PC platform computers with proficiency in Excel and Word to enter data and generate correspondence accurately. Ability to learn and become proficient in eRegulatory systems, IRB portals, vendor portals and sponsor portals. A critical thinker with strong attention to detail and superb problem-solving abilities. Must be able to effectively communicate verbally and in writing. Working Conditions Indoor, Office environment. Essential physical requirements include sitting, typing, standing, and walking. Lightly active position, occasional lifting of up to 20 pounds. Reporting to work, as scheduled, is essential. Ability to work overtime, weekends, and/or holidays as needed. Ability to travel as needed. Remote work arrangement depending on location. CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.

Job Title : Regulatory Support Remote Option: Yes. But the candidate should be available to attend customer meetings twice in a month Requirements Mandatory skills: • experience in pharmaceutical environment. • Experience in regulatory environment is required. • High level exposure or knowledge about FDA inspection and internal audit process. • Knowledge or exposure on Veeva RIM Submission/Archive, Publishing etc. Job Title: Consultant JD details : • Ensure compliance with company Standard Operating Procedures and regulatory agency regulations/guidance. • Represents Regulatory Affairs on cross-functional project teams. • Provide technical expertise to cross-functional teams on managing the lifecycle of submission-related documents. • Work with subject matter experts, and cross functional departments to support business needs. • Effectively communicate and work collaboratively with cross-functional teams, including regulatory affairs, clinical operations, and quality assurance & validation. • Gather and assemble information necessary for submissions in accordance with regulations/guidance. • Capable of reviewing documentation with a high degree of attention to detail. Proactive to identify issues and propose solutions, as necessary. • Conduct review of published submissions to ensure consistency and compliance with regulatory requirements. • Maintain knowledge of local and global regulatory submission requirements. • Maintain compliance with GxP, government regulations, industry standards, approved specifications, and Company procedures &directives. • Provide Regulatory Affairs support during internal and external audits and inspections. • Exposure in Change management process, requirement gathering, qualifying the changes etc., • Actively participate in the development of Regulatory Operations processes like SOPs/GOPs, Work instructions, Checklist, templates etc. • Consistently support for regulatory systems access and change management. • Responsible for communicating business process improvements, business related issues, status updates or opportunities. Qualifications: • Bachelors' degree, preferably in a life science or a related field • 5 to 10 years of experience in pharmaceutical environment. • Experience in regulatory environment is required. • Excellent written, verbal communication and presentation skills. • High level exposure or knowledge about FDA inspection and internal audit process.

Job Description Spectrum Vascular is an innovative medical device company focused on vascular access and medication management. Our mission is to improve the lives of patients worldwide by providing caregivers with high quality, innovative products with exceptional customer service. We are a company that was formed through the acquisition of a portfolio of trusted products that have been widely used by customers for decades. Innovation has been a core strategic pillar throughout our history and many of our products have been designed to deliver antimicrobial and antithrombogenic protection or to support certain patient populations such as those who are critically ill and pediatrics. This role represents a unique opportunity to join a dynamic and growing team with established products and an entrepreneurial mindset. Role Description: dThe Regulatory Affairs (RA) Specialist is responsible for supporting global regulatory submissions and compliance activities to ensure medical device products meet applicable regulatory requirements throughout their lifecycle. This role collaborates cross-functionally with Quality, Engineering, Clinical, and Manufacturing teams to prepare, submit, and maintain regulatory filings with agencies such as the U.S. FDA, European Notified Bodies, and other international authorities. ● Assist in the preparation, formatting, and compilation of regulatory submissions (e.g., FDA 510(k), EU MDR Technical Documentation, Health Canada, and other global filings) ● Support the maintenance of regulatory files, declarations of conformity, and device listings/registrations. ● Support responses to regulatory agency requests for additional information (AIs, deficiency letters, technical queries). ● Support U.S. and EU market approval processes and ensure compliance with regulatory standards ● Support post-market submissions (progress reports, annual reports, etc.) ● Provide regulatory assessments for marketing, R&D, and manufacturing changes or product transfers ● Communicate with distributors in response to requests for information, regulatory inquiries or in support of regulatory filings. Compliance & Quality System Support ● Collaborate with Quality Assurance to ensure continued compliance with applicable regulatory standards, including FDA 21 CFR 820, ISO 13485, and EU MDR 2017/745. ● Participate in internal audits, management reviews, and external audit preparations as needed. ● Support document control and recordkeeping to ensure regulatory documentation integrity and traceability. Cross-Functional Collaboration ● Work closely with Quality, Engineering, and Clinical teams to gather information needed for submissions and documentation. ● Assist in preparing summaries, tracking deliverables, and ensuring timely submission of regulatory documents. ● Support training and awareness initiatives related to regulatory compliance. ● Interpret new or existing regulations and ensure business practices align with compliance requirements ● Create documentation in response to customer regulatory requests which includes regulatory letters, authorization letters, certifications, attestations, technical packages, etc. for tenders and for pre-market clearance. ● Clearly and effectively communicate team/project progress/status, decisions, timelines, etc. to other teams/departments and executive leadership. ● Establish and maintain regulatory information systems ● Contribute to continuous improvement initiatives and process optimization within RA What You Bring: ● Bachelor's degree in a scientific area (RAC certification preferred) ● 1-3 years of experience in a regulated FDA environment (medical devices or combination products) ● Hands-on experience with 510(k) submissions (IDE and PMA knowledge a plus) ● Strong understanding of FDA and EU medical device regulations (international experience desirable) ● Internship or exposure to FDA, EU MDR, or ISO regulatory environments preferred.Strong organizational, communication, and planning skills ● Proficiency with PC systems and office applications ● Solid understanding of scientific principles applied to regulatory affairs Spectrum Vascular is an Equal Opportunity Employer and committed to creating a diverse and inclusive company culture. Spectrum Vascular does not discriminate against candidates and employees because of their disability, sex, race, gender identity, sexual orientation, religion, national origin, age, veteran status, or any other protected status under the law.

Senior Clinical Research Regulatory Specialist (Remote) The Senior Clinical Research Regulatory Specialist works closely with our Clinical Research staff to provide excellent regulatory oversight for our clinical trials under the supervision of the Regulatory Manager. DUTIES & RESPONSIBILITIES Prepare, facilitate, and coordinate the process for accurate and timely submission of Institutional Research Board (IRB) applications for protocol revisions or amendments to reflect any new treatment procedures, administrative changes, changes in subject population, funding, recruitment procedures, site changes, changes in the informed consent, or dual enrollment to additional studies for IRB approved protocols as required by federal regulations and internal policy Ensure that all documents are complete, and that the submission packet meets the IRB's revision submission requirements prior to sending to the IRB Follow-up, communicate and facilitate responses to queries of the IRB, Sponsor and other committees as a result of their review of submissions Coordinate the preparation and submission of consent forms in compliance with the regulatory requirements of federal, state, and local agencies governing biomedical research Obtain Sponsor approval of consent form prior to submission to the IRB Facilitate and coordinate the timely and accurate submission of regulatory documents (such as but not limited to: FDA form 1572, protocol signature page, delegation of authority logs, etc) and IRB submissions by collaborating with research nurses, clinical research coordinators, and investigators in the preparation of regulatory documents Create and maintain regulatory documents in collaboration with the clinical site Ensure that regulatory ISF binders are audited and maintained routinely Track workload and status of pending protocols and associated supporting documents to provide efficient customer service to the Research team Participates in quality assurance (QA) and control programs related to overall project and patient data, as needed Oversees QA initiatives for the department to support research staff and leaders during sponsor and FDA audits Provide training and supervision on assigned regulatory staff members Any other matters as assigned by management KNOWLEDGE & EXPERIENCE Education: Associates degree required Bachelor's degree preferred Experience: 2+ years of clinical research coordinator experience or 3+ years of clinical regulatory experience (or equivalent) Credentials: N/A Knowledge and Skills: Strong written and oral communication skills. Proven leadership skills in project management, including project management tools and techniques. Strong computer skills, including Microsoft Office, Excel, and PowerPoint. Ability to manage time sensitive projects to meet deadlines. Strong ability to establish and maintain effective working relationships. All employees of DM Clinical Research, In any capacity, are expected to: Always treat others with dignity and respect Always conduct themselves in an ethical manner Comply with all local, state, and Federal, including FDA, regulations pertaining to the conduct of clinical trials on human subjects Comply with departmental and company expectations, policies, and procedures at all times Report to work as scheduled and seek approval from your supervisor in advance for any changes to the established work schedule, including the use of leave and late or early arrival and departures. Perform assigned duties and responsibilities with the highest degree of trust. Protect patient privacy at all times by keeping discussion of names and medical conditions confined to private locations, out of earshot of anyone not employed by DMCR. Be polite, upbeat, and professional, on the phone and in person. Maintain a high level of professionalism with CRAs and any Sponsor or CRO employee or representative

**School of Medicine, Stanford, California, United States** Research Post Date Nov 19, 2025 Requisition # 107768 The Blood & Marrow Transplantation and Cellular Therapy (BMT-CT) Divisionis seeking a Clinical Trials Regulatory Specialist II position to support a very active clinical trials faculty. The position will anticipate and generate reports and prepare documents for submission as required by the IRB, FDA, OSP and APB requirements, including annual reports, and IND safety reports. The position will author and submit new applications according to CFR 21 Part 312 including Investigator New Drug (IND) applications, revisions, amendments, and Informed Consent documents in support of BMT-CT clinical research and coordinate with the Stanford Cancer Clinical Trials Office (CCTO) for submission to the FDA according to established procedures. The position will gather, evaluate, organize and manage information from a variety of sources to draft/finalize biomedical research protocols during the development phase, including draft content and formatting to meet requirements of Stanford, Institutional Review Board (IRB), United States Food and Drug Administration (FDA), Office of Science Policy (OSP) and APB (Biosafety Committee). The BMT-CT program at Stanford performs autologous and allogeneic transplantations for over 400 patients each year. The program has been very successful with a history of limited morbidity rates and acute mortality that is well below most published reports. In addition to a successful clinical practice, our program researchers are translating their discoveries into new therapies, advancing the efficacy of hematopoietic cell transplantation for patients worldwide. This is a hybrid eligible position. **Duties include:** + Prepare regulatory submissions (such as IRB and IND/IDE) and applications and annual reports. Complete all related regulatory documents and maintain correspondence and telephone contacts with regulatory agencies. Submit annual reports and updates as required. + Serve as expert liaison in specialized compliance or scientific area between the investigators and regulatory agencies. Provide regulatory support, guidance, and information to principal investigators and research staff. May consult on protocol development. + Develop, deliver and manage tools to facilitate education and training, prepare written materials to communicate with research community including presentations, one-on-one training and orientation sessions. + Oversee and maintain regulatory documentation, safety reporting procedures and audit safety reports to ensure they are appropriately handled. + Evaluate and analyze the impact on new regulations and determine how to implement within unit. Apply knowledge of international, federal, state and local regulations as well as university policies to ensure optimal compliance. + Serve as primary liaison on safety issues and reporting procedures with the IRB, OSR, RMG or other internal organizations or committees. + May manage projects related to regulatory activities and clinical operations, develop the regulatory strategy for project teams. + May hire, orient, and provide ongoing training and direct supervision to regulatory staff. Assign work tasks, provide daily supervision of these tasks; provide verbal and written evaluation of work performance. + May contribute to establishing and developing Standard Operating Procedures for the conduct of clinical research. Ensure SOPs are compliant with international, federal, state, and local regulations, and consistent with the objectives of the clinical research operation. **DESIRED QUALIFICATIONS:** + Experience with Protocol/IND writing. + Experience with BMT-CT disease focus. **EDUCATION & EXPERIENCE (REQUIRED):** + Bachelor's degree and five years of related experience or a combination of education and relevant experience. **KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):** + Excellent communication and organizational skills and superb attention to detail. + Experience with MS Office products and database applications required. + Excellent inter-personal skills and customer service focus is required. + Experience in clinical research management and oversight, including project management in a dynamic research setting. + Strong knowledge of regulatory affairs, including FDA regulations, IRB review and approval process, and Good Clinical Practice. + Experience in developing and implementing training/education. + Demonstrated ability to manage multiple projects and staff under varying time constraints. + Strong writing skills. **PHYSICAL REQUIREMENTS*:** + Frequently sit, grasp lightly, use fine manipulation and perform desk-based computer tasks, lift, carry, push pull objects that weigh to ten pounds. + Occasionally sit, use a telephone or write by hand. + Rarely kneel, crawl, climb, twist, bend, stoop, squat, reach or work above shoulders, sort, file paperwork or parts, operate foot and hand controls. **WORKING CONDITIONS:** + May require occasional local and overnight travel. **WORKING STANDARDS:** + Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations. + Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned. + Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide,******************************** **The expected pay range for this position is $123,470 to $143,544 per annum.** **Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs.** **At Stanford University, base pay represents only one aspect of the comprehensive rewards package. The Cardinal at Work website (** ******************************************************** **) provides detailed information on Stanford's extensive range of benefits and rewards offered to employees. Specifics about the rewards package for this position may be discussed during the hiring process.** **Why Stanford is for You** Imagine a world without search engines or social platforms. Consider lives saved through first-ever organ transplants and research to cure illnesses. Stanford University has revolutionized the way we live and enrich the world. Supporting this mission is our diverse and dedicated 17,000 staff. We seek talent driven to impact the future of our legacy. Our culture andunique perksempower you with: + **Freedom to grow.** We offer career development programs, tuition reimbursement, or audit a course. Join a TedTalk, film screening, or listen to a renowned author or global leader speak. + **A caring culture.** We provide superb retirement plans, generous time-off, and family care resources. + **A healthier you.** Climb our rock wall or choose from hundreds of health or fitness classes at our world-class exercise facilities. We also provide excellent health care benefits. + **Discovery and fun.** Stroll through historic sculptures, trails, and museums. + **Enviable resources.** Enjoy free commuter programs, ridesharing incentives, discounts and more. _Consistent with its obligations under the law, the University will provide reasonable accommodations to applicants and employees with disabilities. Applicants requiring a reasonable accommodation for any part of the application or hiring process should contact Stanford University Human Resources by submitting a_ _contact form_ _._ _Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law._ _The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned._ Additional Information + **Schedule: Full-time** + **Job Code: 4942** + **Employee Status: Regular** + **Grade: I** + **Requisition ID: 107768** + **Work Arrangement : Hybrid Eligible**