Regulatory Specialist remote jobs - 155 jobs

#134458 Manager, Regulatory Affairs - Hybrid will remain open until a successful candidate has been identified. This position will work a hybrid schedule which includes a combination of working both onsite at Moores Cancer Center and remote. DESCRIPTION The Moores Cancer Center (MCC) is one of just 53 NCI-designated Comprehensive Cancer Centers in the United States and the only one in San Diego County. As a consortium cancer center, it is a collaborative partnership that brings together UC San Diego, San Diego State University, and the La Jolla Institute of Immunology to advance cancer research and care. Reporting directly to the Executive Administrative Director of the Moores Cancer Center Clinical Trials Office (CTO), the Manager, Regulatory Affairs leads a team of Regulatory Coordinators and takes on key programmatic responsibilities to strengthen regulatory practices across the clinical research organization. The incumbent demonstrates expertise in regulatory matters, serves as a subject matter expert when engaging with sponsors and auditors, and designs large‑scope, high‑complexity research projects that drive the MCC CTO's overall success. Managing a team of highly skilled professionals in a matrixed organization, the Regulatory Manager ensures the achievement of the MCC CTO's activation targets and ongoing compliance with regulatory requirements for all active clinical trials under the CTO's purview. Lead the CTO Regulatory Affairs unit to support compliant study activation and management of active clinical trials managed by the CTO. Apply extensive knowledge of clinical research protocols and processes to design research projects of large scope and high degrees of complexity. Provide direction on programmatic efforts and developing systems to streamline regulatory processes in a compliant manner. MINIMUM QUALIFICATIONS Nine years of related experience, education/training, OR a Bachelor's degree in related area plus five years of related experience/training. Clinical Trial Professional certification from a professional society within one year in position. Broad knowledge of clinical or laboratory research and clinical research philosophy; demonstrated ability to translate clinical research philosophy into business best practices in a trial setting. Demonstrated project management skills; ability to effectively manage multiple priorities and meet the demands of a fast‑paced and dynamic work environment. Demonstrated experience managing people with a wide range of educational backgrounds and skills; demonstrated management and conflict resolution skills to effectively lead and motivate others. Strong communicator; includes verbal and written, active listening, critical thinking, persuasiveness, advising and counseling skills. Excellent interpersonal skills, including problem‑solving, teamwork development, leadership, mentorship, and ability to cultivate relationships with multiple stakeholders at various levels of administration. Proficiency with word processing, spreadsheet software, clinical trial management systems, and clinical information and documentation application programs. Collaboration skills to interface and coordinate with cross‑functional teams and influence and persuade in program integration. PREFERRED QUALIFICATIONS Advanced degree. PAY TRANSPARENCY ACT Annual Full Pay Range: $97,200 - $182,000 (will be prorated if the appointment percentage is less than 100%). Hourly Equivalent: $46.55 - $87.16. EQUAL OPPORTUNITY EMPLOYER STATEMENT The University of California is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected status under state or federal law. #J-18808-Ljbffr

A leading pharmaceutical company in San Diego is seeking a Regulatory Affairs Manager to oversee regulatory strategies for their development programs. You will work with cross-functional teams to ensure timely submissions and maintain regulatory compliance. The position requires a scientific degree and substantial experience in in relevant regulatory affairs. Benefits include competitive salary and health insurance. #J-18808-Ljbffr

A global investing platform is seeking a Compliance Chief Officer to design and implement a comprehensive regulatory operating system. You will lead SEC registration and ensure ongoing compliance while advising on fund structuring decisions. The ideal candidate brings over 7 years of experience in compliance at investment firms and possesses knowledge of SEC regulations. The position offers significant equity potential and is primarily remote with a preference for candidates in US time zones. #J-18808-Ljbffr

Vivo HealthStaff is actively recruiting a Telemedicine Physician for a long-term locum tenens position with a leading physical medicine clinic based in California. This fully remote opportunity enables physicians to provide critical care for patients without the need for in-person visits, offering flexibility while supporting a specialized medical practice. The Telemedicine Physician will play a crucial role in managing cases related to Traumatic Brain Injury (TBI) and personal injury assessments. **Position Details:** In this role, physicians will work between 2 to 5 days per week, partnering with a physical medicine and rehabilitation (PMR) clinic dedicated to providing high-quality care to patients dealing with TBI and other injuries. Your responsibilities will primarily include conducting virtual examinations for TBI assessments, personal injury cases, and other related medical conditions. This is an ideal role for physicians interested in long-term telemedicine work and building continuity with patients remotely. **Benefits:** - Competitive hourly rate - Weekly payments via direct deposit - Medical malpractice coverage provided - Completely digital onboarding process for quick and easy setup **Requirements:** - Active and unrestricted California Medical License - Active and unrestricted DEA license - Board eligibility or certification in one of the following: - Preventive Medicine - Occupational Medicine - Physical Medicine and Rehabilitation - Pain Management - Neurology

Clorox is the place that's committed to growth - for our people and our brands. Guided by our purpose and values, and with people at the center of everything we do, we believe every one of us can make a positive impact on consumers, communities, and teammates. Join our team. #CloroxIsThePlace Your role at Clorox: The Senior Regulatory Specialist will serve as a strategic regulatory partner for the Burt's Bees business, supporting product development, commercialization, brand maintenance, implementation of regulatory best practices, and maintaining a robust compliance program for our personal care and over-the-counter (OTC) drug products. This role independently leads regulatory activities, ensuring compliance with global regulations while enabling innovation and speed to market. Daily cross-functional collaboration is essential, involving teams across Product Safety & Regulatory Affairs (PS&RA), Product Development, Legal, Corporate Quality, Marketing, and Government Affairs. Through this work, you will play a key role in accelerating profitable growth, driving structural margin expansion, and unlocking value through transformation. This job will be a fully remote position based in the United States. In this role, you will: Regulatory Strategy & Project Leadership Independently represent the PS&RA function on cross-functional project teams, ensuring regulatory compliance and timely project execution. Develop and execute regulatory strategies for cosmetics, personal care, and OTC products, ensuring alignment with business goals. Analyze and interpret regulatory data to provide strategic recommendations and influence project direction. Identify regulatory risks and mitigation strategies to support successful product launches. Maintain and update State and Federal reporting requirements related to your project categories (e.g., California Safe Cosmetics SB 312, CDER, Cosmetics Direct). Documentation & Communication Prepare and review regulatory documentation including but not limited to ingredient assessments, formula reviews, product dossiers, claims, packaging labels, marketing communication materials. Translate complex regulatory and technical information into clear, actionable guidance for internal stakeholders. Effectively communicate with internal teams and external partners, including regulatory authorities and industry groups. Contribute to the development and implementation of effective documentation and data control management for compliance files within the Regulatory Information Management System. Cross-Functional Collaboration Lead cross-functional collaboration with R&D, Legal, Quality, and Marketing teams. Provide regulatory guidance throughout the product lifecycle, from concept to commercialization. Mentor junior team members and contribute to building regulatory capability across the organization. External Engagement & Best Practices Represent the company in external forums, including trade associations and regulatory working groups. Define and teach regulatory best practices within the team and broader organization. What we look for: Required Qualifications & Skills Bachelor's degree in scientific discipline (e.g., Cosmetic Science, Chemistry, Biology, Toxicology). 7+ years of regulatory experience in the CPG industry, with 3+ years specifically in the cosmetic and personal care space. Strong knowledge of FDA regulations [e.g., The Food Drug and Cosmetic Act (FD&C Act), Modernization of Cosmetics Regulation Act (MOCRA)], global regulatory frameworks (including European Union, Canada and Asia markets), and OTC drug regulations/monographs. Proven ability to lead project regulatory strategies and influence cross-functional teams. Excellent written and verbal communication skills. Results driven: Excellent operational skills including planning, organization and attention to detail. Ability to develop effective solutions to diverse and complex business problems. Desired Qualifications Experience with natural products and botanical ingredients. Knowledge of ISO 16128 (Natural and Organic Cosmetic Ingredients and Products). Familiarity with sustainability and clean beauty standards. #LI-Remote Workplace type: This position will be a fully remote position based in the United States. Our values-based culture connects to our purpose and empowers people to be their best, professionally and personally. We serve a diverse consumer base which is why we believe teams that reflect our consumers bring fresh perspectives, drive innovation, and help us stay attuned to the world around us. That's why we foster an inclusive culture where every person can feel respected, valued, and fully able to participate, and ultimately able to thrive. Learn more. [U.S.]Additional Information: At Clorox, we champion people to be well and thrive, starting with our own people. To help make this possible, we offer comprehensive, competitive benefits that prioritize all aspects of wellbeing and provide flexibility for our teammates' unique needs. This includes robust health plans, a market-leading 401(k) program with a company match, flexible time off benefits (including half-day summer Fridays depending on location), inclusive fertility/adoption benefits, and more. We are committed to fair and equitable pay and are transparent with current and future teammates about our full salary ranges. We use broad salary ranges that reflect the competitive market for similar jobs, provide sufficient opportunity for growth as you gain experience and expand responsibilities, while also allowing for differentiation based on performance. Based on the breadth of our ranges, most new hires will start at Clorox in the first half of the applicable range. Your starting pay will depend on job-related factors, including relevant skills, knowledge, experience and location. The applicable salary range for every role in the U.S. is based on your work location and is aligned to one of three zones according to the cost of labor in your area. -Zone A: $106,700 - $204,900 -Zone B: $97,800 - $187,900 -Zone C: $88,900 - $170,800 All ranges are subject to change in the future. Your recruiter can share more about the specific salary range for your location during the hiring process. This job is also eligible for participation in Clorox's incentive plans, subject to the terms of the applicable plan documents and policies. Please apply directly to our job postings and do not submit your resume to any person via text message. Clorox does not conduct text-based interviews and encourages you to be cautious of anyone posing as a Clorox recruiter via unsolicited texts during these uncertain times. To all recruitment agencies: Clorox (and its brand families) does not accept agency resumes. Please do not forward resumes to Clorox employees, including any members of our leadership team. Clorox is not responsible for any fees related to unsolicited resumes.

This position is responsible for acquiring and maintaining product registrations for domestic and international markets. Provide direction to the business as necessary regarding applicable U.S. and international regulations. Research and analyze applicable legislation and Federal, State and Local regulations to ensure the company's ongoing compliance. KEY RESPONSIBILITIES: Research and analyze applicable laws and regulations; develop and implement the necessary policies and procedures to ensure the Company's ongoing compliance with Federal, State and local requirements. Initiate and maintain medical device product registrations globally, focusing on international markets. Support the development of Regulatory strategies and processes. Works with subsidiary office personnel and distributors to provide direction and assistance in all matters of product legal/regulatory compliance, registrations and availability in domestic/international markets. Ensure only products legally registered are sold into international markets in accordance with U.S. export regulations. Assist in SOP development and review. Provide regulatory input to product lifecycle planning. Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions Determine and communicate submission and approval requirements Participate in risk benefit analysis for regulatory compliance Assess the acceptability of quality, preclinical and clinical documentation for submission filing Compile, prepare, review and submit regulatory submission to authorities Monitor impact of changing regulations on submission strategies Monitor applications under regulatory review Provide support during inspections and formulating the appropriate response and corrective actions Assist compliance with product post marketing approval requirements Review regulatory aspects of contracts Assist with label and Instructions for Use (IFU) development and review for compliance before release Ability to manage multiple establishment and product registration activities Submit and review change controls to determine the level of change and consequent submission requirements Provide regulatory input for product recalls and recall communications Other duties as assigned. SPECIFIC KNOWLEDGE & SKILLS: 2-4 years preferred experience in medical device (U.S. FDA regulated and registered) Manufacturer or Specification Developer in the U.S. and/or Foreign regulatory submissions. Experience with FDA pre-market submissions preferred. Experience with ISO 13485 and EU MDR preferred GENERAL SKILLS & COMPETENCIES: Good understanding of industry practices Proficient with tools, systems, and procedures Basic planning/organizational skills and techniques Good decision making, analysis and problem solving skills with ability to multi-task Good verbal and written communication skills Good presentation and public speaking skills Good interpersonal skills Basic conflict resolution skills Developing professional credibility MINIMUM WORK EXPERIENCE: Typically 2 to 4 or more years of increasing responsibility in terms of any applicable professional experience. PREFERRED EDUCATION: Typically a Bachelor's Degree or global equivalent in related discipline. TRAVEL / PHYSICAL DEMANDS: Travel typically less than 10%. Office environment. No special physical demands required. The posted range for this position is $61,812-$84,992, which is the expected starting base salary range for an employee who is new to the role to fully proficient in the role. Many factors go into determining employee pay within the posted range including prior experience, current skills, location/labor market, internal equity, etc. This position is eligible for a bonus not reflected in the posted range. Other benefits available include: Medical, Dental and Vision Coverage, 401K Plan with Company Match, PTO, Paid Parental Leave, Income Protection, Work Life Assistance Program, Flexible Spending Accounts, Educational Benefits, Worldwide Scholarship Program and Volunteer Opportunities. Henry Schein, Inc. is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status. For more information about career opportunities at Henry Schein, please visit our website at: *************************** Fraud Alert Henry Schein has recently been made aware of multiple scams where unauthorized individuals are using Henry Schein's name and logo to solicit potential job seekers for employment. Please be advised that Henry Schein's official U.S. website is ******************* . Any other format is not genuine. Any jobs posted by Henry Schein or its recruiters on the internet may be accessed through Henry Schein's on-line "career opportunities" portal through this official website. Applicants who wish to seek employment with Henry Schein are advised to verify the job posting through this portal. No money transfers, payments of any kind, or credit card numbers, will EVER be requested from applicants by Henry Schein or any recruiters on its behalf, at any point in the recruitment process.

Join us and celebrate the beauty of human experience. Create for happier, healthier lives, with love for nature. Together, with our customers, we deliver food innovations, craft inspired fragrances and develop beauty and wellbeing solutions. There's much to learn and many to learn from, with more than 16,000 employees around the world to explore ideas and ambitions with. In the USA, we develop, market and produce a wide array of solutions from our 25 most innovative sites, based across the country. Stretch your skills, create and get inspiration from passionate colleagues. Every day, your energy, your thirst for knowledge, and your creativity will shape our future, making a positive difference on billions of people. Every essence of you enriches our world. We are Givaudan. Human by nature. Job Purpose As a Regulatory Specialist, you will provide expert regulatory support to ensure product compliance with global regulations and industry standards. Your role involves communicating regulatory and corporate information with all partners and helping address regulatory challenges through creative and practical input. You will collaborate with internal and external customers, providing consultation on the development of fragrances while staying informed about the latest regulatory trends. You will create customized reports and support projects that address evolving regulatory requirements. Additionally, you will work with teams to facilitate compliance and support product development. This position is ideal for individuals with a technical background who are eager to support regulatory activities. Location East Hanover, New Jersey, US This is a hybrid role, 4 days on-site, 1 day home office. We might require you to relocate to New York's office once per quarter. Responsibilities: * Provide regulatory support to internal and external customers, ensuring compliance with legal requirements and corporate guidelines. * Serve as the primary point of client-facing, encouraging relationships with customers' regulatory and safety contacts to provide a positive and seamless client experience and facilitate business collaboration. * Respond to regulatory requests and acquire information to determine product compliance. * Develop a detailed understanding of applicable regulations and ensure product submissions follow customer, global, and industry standards. * Create customized reports and conduct regulatory impact assessments to inform clients and partners of compliance status and potential risks. * Communicate complex regulatory concepts in a clear, simple, and concise manner to internal non-regulatory stakeholders and external customers. * Help address regulatory requirements and ensure compliance. * Monitor latest legislative issues, and build tasks outlined in the action plan * Provide technical feedback to help creative teams meet regulatory requirements and offer regulatory consultation to develop finished compounds. * Follow established procedures to review data accuracy and ensure compliance with regulatory and company requirements. * Lead the account's regulatory support and support ongoing process improvement efforts to provide exceptional service to enable business growth. Your Professional Profile Includes: * A university degree in a scientific field, with a preferred advanced degree in Chemistry, Biochemistry, Toxicology, or related disciplines. * 2-3 years of regulatory and industry experience. * Proficiency in English and local language, with MS Office skills. * Knowledge of industry and customer regulatory requirements, including technical criteria and specifications. Salary expectation based on experience: $75,000 - $90,000 #LI-hybrid #ZR At Givaudan, you contribute to delightful taste and scent experiences that touch people's lives. You work within an inspiring teamwork culture - where you can thrive, collaborate and learn from other talented and passionate people across disciplines, regions and divisions. Every essence of you enriches our world. Diversity of perspectives fuels innovation and fosters deeper connections with our employees, customers, and partners. At Givaudan, we are dedicated to cultivating an inclusive environment where every individual's voice is valued and has the power to shape our world. Join us in making a difference together. Remote working: Hybrid At Givaudan, you contribute to delightful taste and scent experiences that touch people's lives. You work within an inspiring teamwork culture - where you can thrive, collaborate and learn from other talented and passionate people across disciplines, regions and divisions. Join us and Impact Your World Diversity drives innovation and creates closer connections with our employees, customers and partners. Givaudan embraces diversity and is committed to building an inclusive environment where everyone impacts our world.

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.

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.

Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. With programs like Future of Medicine , which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers , which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all. To learn more about Care Access, visit ******************* How This Role Makes a Difference Care Access is seeking a skilled and experienced Specialist, Regulatory Operations to join our dynamic Global Regulatory Operations Team, part of the Global Expansion and Study Operations department. The Specialist, Regulatory Operations will oversee and execute all site-level regulatory operational activities for assigned clinical trials in the U.S. They may also support regulatory activities for Canadian sites as needed. This role is responsible for ensuring compliance with applicable U.S. regulations and guidelines and may contribute to site start-up activities for U.S. sites when required. You will have a good understanding of U.S. regulatory requirements and experience supporting regulatory activities for clinical research sites. How You'll Make An Impact Study-specific regulatory operations: Act as main regulatory operations contact for assigned studies Support regulatory compliance activities for U.S. clinical research sites, ensuring to adherence to FDA, -OHRP and global regulatory standards. Coordinates preparation and review of key site essential records. Assist in preparing for sponsor monitoring visits and follow up requirements, ensuring compliance and --readiness for assigned studies. Provide regulatory guidance to the site operations teams, ensuring that activities align with current regulations and industry best practices. Review study information and understand start-up timelines, requirements, key contacts, and performance expectations Track essential records and timelines Support the site(s) through the Site Evaluation Visit, Site Initiation Visit, greenlight to consent, and Study Closeout. Actively work towards KPIs to help ensure departmental success Supports creation and maintenance of study Delegation of Authority (DOA) logs Support regulatory activities throughout the duration of the study life cycle; collaborating with clinical operations teams to ensure regulatory compliance Coordinate and perform IRB site level submissions and maintenance of approvals throughout the life of the study. Review, and submit high-quality and timely IRB submission materials, including but not limited to protocols, ICFs and marketing materials. Reviews and customize, when required, ICFs to ensure compliance with U.S. IRB requirements and site feedback. Liaise and follow up directly with Sponsor. Ensures accurate compilation, management and tracking of submissions. Oversee regulatory documentation, tracking, and reporting processes to maintain compliance and readiness Ensure timely filing of safety reports, deviations, and amendments/modifications as per study requirements. Ensures that Investigator Site File (ISFs) are completed, up to date, accurate and in compliance with Good Clinical Practice (GCP), regulatory requirements and internal processes. Oversee and support study close-out activities by ensuring proper archiving and retention of ISF documents for regulatory inspections and sponsor audits. Milestones: Tracks and updates the study team accordingly Other Responsibilities Collaborate with cross-functional teams, including Quality and Clinical Operations, to ensure regulatory requirements are met. Identify process gaps, and support the development, implementation, and continuous improvement of new departmental processes. Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive. The Expertise Required Ability to communicate and work effectively with a diverse team of professionals Communication Skills: Good verbal and written communication skills as evidenced by positive interactions with coworkers, management, clients, and vendors Team Collaboration Skills: Work effectively and collaboratively with other team members to accomplish mutual goals. Bring positive and supportive attitude to achieving these goals Good computer skills with demonstrated abilities using clinical trials database, MS word and excel Experience in electronics Investigator Site Files systems like (Florence, CRIO) Curiosity and passion to learn, innovate, able to take thoughtful risks and get things done Friendly, outgoing personality with the ability to maintain a positive attitude under pressure High level of self-motivation and energy Ability to work independently in a fast-paced environment with supervision Must have a client service mentality Demonstrated success in managing IRB submissions Detail-oriented with good problem-solving abilities and a proactive approach to regulatory challenges Ability to handle multiple tasks in a fast-paced and constantly changing environment. Certifications/Licenses, Education, and Experience: Bachelor's degree in a scientific or healthcare-related field; advanced degree preferred or equivalent experience Minimum of 2 years of experience in operational regulatory affairs within theresearch site (preferable), or -CRO/pharmaceutical industry. Understanding of U.S. regulations and ICH GCP guideline as they relate to site operations Good knowledge of site-level regulatory requirements for the execution and maintenance of clinical trials in the U.S. Proven ability to support sites in IRB submissions, regulatory document preparation, and ongoing compliance. How We Work Together Location: Remote within the United States. This role requires 100% of work to be performed in a remote office environment. Travel: This is a remote position with less than 10% travel requirements. Occasional planned travel may be required as part of the role. Physical demands associated with this position Include: The ability to use keyboards and other computer equipment. Benefits & Perks (US Full Time Employees) Paid Time Off (PTO) and Company Paid Holidays 100% Employer paid medical, dental, and vision insurance plan options Health Savings Account and Flexible Spending Accounts Bi-weekly HSA employer contribution Company paid Short-Term Disability and Long-Term Disability 401(k) Retirement Plan, with Company Match Diversity & Inclusion We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Care Access is unable to sponsor work visas at this time. If you need an accommodation to apply for a role with Care Access, please reach out to: ********************************

Shift: Monday through Friday, 8:00AM - 5:00PM less than 20 hours per week Are you ready to work making the world a safer, healthier place? Join our mission to continuously move science forward; to innovate and advance all aspects of our business to improve the health and safety of our communities and lives. Make an impact. Build a career. At Pace , everything we do is built upon an unwavering commitment to making the world a safer, healthier place. We continually work to develop innovative practices that drive sustainability and empower our partners with accurate, quality data at every critical moment and milestone. That's why we need you - your curiosity, your talents, and your drive - to help us advance this important work, and your career. Find your place at Pace Join us as a Regulatory Analyst, where you'll put your love of science to work in the Scientific Insourcing Solutions division. You'll receive all the training you need to successfully take on your new role and grow an exciting laboratory sciences career at Pace . Chemical Regulatory Consultant PRN Provide broad chemical regulatory consulting support and guidance as it applies to our client's products. Research, author, and review regulatory submissions with EPA, hazard communication documentation, and other regulatory consulting support as requested. Compensation: $75.00 - 95.00 per hour NOTE: Position is PRN (flexible weekly hours and non-benefits eligible) 5-10+ years of experience in chemical regulatory Global chemical regulatory literature/data reviews of products and raw materials Technical support for global chemical regulatory related inquiries Must have experience submitting PMNs, LVEs, etc. with EPA Must have experience with TSCA, DOT, Prop 65, EU REACH, and other relevant regulatory concepts Report on emerging science and new methodologies in the field of regulatory as requested Bachelor's degree or higher in Chemistry or related field Ability to interpret global product regulatory concepts Knowledge of test data and ability to interpret chemical test data Independently works within specific computer systems and databases Can manage multiple client projects, including set up, data collection, and on-time delivery of requested deliverables Excellent written and verbal communication skills with experience working in a client facing role Find Your Place at Pace - We need you - your curiosity, your talents, and your drive - to help us advance this important work. Benefits When you join Pace , you commit to work that makes a positive impact on our communities and our world. We commit to supporting you with benefits and perks that make a positive impact on your life. Full-time roles are eligible for our comprehensive benefits program which includes competitive salaries, medical, dental vision, 401K retirement savings plan (100% vested immediately in the employer match), life, disability and voluntary benefits, paid time off for holiday, sick and vacation days, HSA, wellness program, flexible spending accounts, tuition reimbursement, Employee Assistance program, parental leave, optional legal coverage and ID theft. Equal Opportunity Employer Pace provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, creed, color, religion, genetics, protected veteran status, national origin, sex, age, disability, marital status, sexual orientation, gender identity or expression, citizenship, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities • Under supervision and with guidance from more senior service line colleagues: Performs Assembler tasks within the document publishing system, including, but not limited to, creating publications, modifying outline, assigning and transforming documents, and adding cross references. Performs Publishing tasks within the electronic publishing system, including, but not limited to, adding special sheets, applying rules, preparing for publishing, and publishing. Performs QC tasks within the electronic publishing system and QC of the published output. May QC materials prepared by team or client. May create, key, and assemble client deliverable documents and submissions using standard word processing or publishing systems and utilities (Extedo's eCTDManager and eSUBmanager, CoreDossier, ISI Toolbox, ISI Publisher, eCTDXpress, eValidator, Acrobat and others). Takes lead role in preparing full application submission builds. Troubleshoots issues with eCTD builds and provide guidance to the entry level publishers. Provides assistance and guidance to entry-level publishers. May review documents for legibility, completeness, and accuracy. May log and track regulatory documents, publications, and other relevant materials. May organize and compile regulatory documentation, perform pagination, clean-up, and duplication tasks. May receive and deliver client information/documents, with significant supervision. May provide alternatives for completing assigned tasks. Prepares and assembles applications (INDs, NDAs, ANDAs, DMFs, variations, routine reports, renewals etc.) for submission to global regulatory authorities. Leads team to produce compliant, submission-ready PDFs from the Word source files Completes report level publishing (CSR, DSUR, PSUR, Protocols) Completes CSR submission assembly Experience with collaborative authoring and Dynamic Linking in Veeva Vault Publishing would be highly preferable Experience working closely with Document authors/functional SMEs to ensure global quality is built into the Word source docs to reduce time-to-file and promote global document reusability SME on global submission-ready standards, Word format, PDF formatting At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. *************************** Additional Information Tasks, duties, and responsibilities as listed in this are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Under the general supervision of the Director, Hollings Cancer Center, Clinical Trials Office, provides functional direction, management, and supervision on a day-to-day basis to the Regulatory staff in the Clinical Trials Office. Oversees the regulatory activities for federal, corporate, and institutional research projects submitted and activated at the Hollings Cancer Center and promotes high quality and efficient regulatory performance as required by the NCI Core Grant. Entity Medical University of South Carolina (MUSC - Univ) Worker Type Employee Worker Sub-Type Classified Cost Center CC001332 HCC CTO Administration Pay Rate Type Hourly Pay Grade University-05 Pay Range 39,764.00 - 56,670.00 - 73,576.000 Scheduled Weekly Hours 40 Work Shift Under the general supervision of the Director, Hollings Cancer Center, Clinical Trials Office, provides functional direction, management, and supervision on a day-to-day basis to the Regulatory staff in the Clinical Trials Office. Oversees the regulatory activities for federal, corporate, and institutional research projects submitted and activated at the Hollings Cancer Center and promotes high quality and efficient regulatory performance as required by the NCI Core Grant. Study Start-up Reporting and Activation Project Management 35% Helps to oversee the study start-up process and manages the start-up timeline of all oncology clinical trials assigned within the respective Hollings Cancer Center Disease Focus Group(s) (DFG). As outlined within the NCI Cancer Center Support Grant, the aim for the average time to activation is 90 calendar days from the time of Protocol Review Committee (PRC) submission. Responsible for timely, accurate, input of required study start-up milestones into the Clinical Trials Data System to facilitate efficient project management and metric tracking. Maintain OnCore per policy, updating study and personnel listings and task lists. Actively monitors start-up milestones across the HCC Clinical Trials Office (CTO), DFG and PRC, Institutional Review Board (IRB) and reports project updates to respective groups. Any trials that exceed NCI CCSG metrics will be properly escalated to the DFG leader and HCC CTO Unit managers. Interfaces with relevant MUSC, sponsor, and Clinical Research Organization (CRO) functional leads to ensure appropriate prioritization of essential document creation to facilitate synchronized start-up and ensure task list deadlines are met. Completes the protocol submission form in the Protocol Review Committee (PRC) portal to initiate the scientific review process. Attends the CTO Pending Projects meetings and specific DFG meetings to provide input into prioritized tasks and follows-up to ensure start-up of studies in a compliant and timely manner. Effectively communicates regulatory requirements within project teams so that scope, timelines and budgets can be assembled accordingly. Provides DFG leaders relevant data on time to activation metrics and assists the leader in identifying new trends and barriers. IRB Application and Document Management 35% Responsible for preparation, submission, outcome follow-up, documentation and communication of all IRB submissions from initial application through termination. This includes amendments, reportable events, and annual renewals. Communicate the study status updates and ensures that the study team has valid study documents to complete tasks. This responsibility commences at the original point of project entry and continues through IRB termination of projects. Efficiently tracks IRB submissions by utilizing the appropriate process task lists and entering accurate submission details and status updates in the clinical trials management system. Collaborates with sponsors/CROs to develop informed consent documents that are compliant with MUSC policies and verifies informed consent language is accurate with appropriate MUSC departments and ancillaries. Determine appropriate IRB of record and type of regulatory submissions or internal documentation that are required and communicate study updates/IRB submission activity to the study team in a timely manner. Is proficient with IRB of record submissions for MUSC, WIRB, Advarra, NCI CIRB, and any other IRB of record for studies assigned. Prepare responses to IRB requests for information or study document revisions. Organizes all study documents per policies within hard copy and electronic systems. Communicates updates and releases IRB approved documents to investigators, sponsors, ancillary teams, and CTO accurately and timely Approval Processing and Quality Assurance 25% Complete sponsor required regulatory documentation as required. Initiate and maintain accurate and comprehensive documentation as required by the sponsor in compliance with all applicable federal, state and local regulations, policies and procedures and Good Clinical Practice guidelines. Effectively applies regulatory knowledge of federal regulation and standards, problem solving and continuous quality improvement methods in daily operations. Create and maintain essential regulatory documents. May go on campus to meet with investigators and staff to obtain signatures for regulatory documents. Maintain accurate and complete hard copy study files Assist with sponsor and internal monitoring visits and reviews and provides regulatory support to effectively meet the needs of monitors and auditors during site visits. Address and report to the IRB any regulatory findings or follow-up items noted by the site monitor/ auditor. Promptly reviews and addresses an quality assurance deficiencies noted for regulatory documentation. Regulatory Unit Support and Continuing Education 5% Participates in training curriculum and continuing education training of employees Participates in Regulatory coverage plans as needed Works effectively and cooperatively with others in achieving organizational goals; maintains harmonious working relationships with fellow employees. Applies MUSC Standards of Behavior to all aspects the job assigned. Participates in monthly regulatory meetings and other HCC CTO staff meetings and application university or HCC trainings. Maintains effective relationships with sponsors/CROs Additional Job Description Minimum Requirements: A bachelor's degree and one year relevant program experience. Physical Requirements: (Note: The following descriptions are applicable to this section: Continuous - 6-8 hours per shift; Frequent - 2-6 hours per shift; Infrequent - 0-2 hours per shift) Ability to perform job functions in an upright position. (Frequent) Ability to perform job functions in a seated position. (Frequent) Ability to perform job functions while walking/mobile. (Frequent) Ability to work indoors. (Continuous) Ability to work outdoors in all weather and temperature extremes. (Infrequent) Ability to work in confined/cramped spaces. (Infrequent) Ability to perform job functions from kneeling positions. (Infrequent) Ability to squat and perform job functions. (Infrequent) Ability to perform 'pinching' operations. (Infrequent) Ability to fully use both hands/arms. (Frequent) Ability to perform repetitive motions with hands/wrists/elbows and shoulders. (Frequent) Ability to reach in all directions. (Frequent) Possess good finger dexterity. (Continuous) Ability to maintain tactile sensory functions. (Continuous) Ability to lift and carry 15 lbs., unassisted. (Infrequent) Ability to lower objects, up to 15 lbs., from height of 36 inches to floor level, unassisted. (Infrequent) Ability to push/pull objects, up to 15 lbs., unassisted. (Infrequent) Ability to maintain 20/40 vision, corrected, in one eye or with both eyes. (Continuous) Ability to see and recognize objects close at hand. (Frequent) Ability to see and recognize objects at a distance. (Frequent) Ability to determine distance/relationship between objects; depth perception. (Frequent) Good peripheral vision capabilities. (Continuous) Ability to maintain hearing acuity, with correction. (Continuous) Ability to perform gross motor functions with frequent fine motor movements. (Frequent) If you like working with energetic enthusiastic individuals, you will enjoy your career with us! The Medical University of South Carolina is an Equal Opportunity Employer. MUSC does not discriminate on the basis of race, color, religion or belief, age, sex, national origin, gender identity, sexual orientation, disability, protected veteran status, family or parental status, or any other status protected by state laws and/or federal regulations. All qualified applicants are encouraged to apply and will receive consideration for employment based upon applicable qualifications, merit and business need. Medical University of South Carolina participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: ***************************************

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: $30.00 - $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.

**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. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights (**************************** notice from the Department of Labor. **Job Category** Laboratory/Production **Job Type** Full-Time

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**

Thank you for your interest in joining Solventum. Solventum is a new healthcare company with a long legacy of solving big challenges that improve lives and help healthcare professionals perform at their best. At Solventum, people are at the heart of every innovation we pursue. Guided by empathy, insight, and clinical intelligence, we collaborate with the best minds in healthcare to address our customers' toughest challenges. While we continue updating the Solventum Careers Page and applicant materials, some documents may still reflect legacy branding. Please note that all listed roles are Solventum positions, and our Privacy Policy: *************************************************************************************** applies to any personal information you submit. As it was with 3M, at Solventum all qualified applicants will receive consideration for employment without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Job Description: Senior Regulatory Affairs Specialist At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers' toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue. We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you. The Impact You'll Make in this Role As a Senior Regulatory Affairs Specialist, you will have responsibility for managing the regulatory compliance for a portfolio of medical devices within the Infection Prevention and Surgical Solutions business. The portfolio of devices includes Class Is, II and III in the EU as well as 510(k) requirements in the US. This role will support on-going product compliance throughout the device's lifecycle allowing you the opportunity to build strong relationships with stakeholders and management. In this role, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by: Developing and executing regulatory strategies to achieve new product market authorizations faster than competitors and with differentiated indications and claims. Managing complex decision-making among cross‑functional stakeholders in an area of regulatory that is complex and evolving. Participating in global business and functional strategic meetings and forums representing regulatory affairs. Performing regulatory assessments and determining registration plans with the business for strategic implementation. Articulating global registration requirements and compiling regulatory documents according to local regulatory requirements. Submitting registration documents and following through on all in‑process evaluations until regulatory authorization is obtained. Acting as the focal point for commercial support pertaining to all regulatory activities. Managing regulatory systems and tools to drive operational excellence for effective data tracking and to ensure regulatory data integrity. Keeping abreast of new regulations and providing necessary regulatory information, updates, and documentation to the organization. Supporting ISO 13485, Medical Device Single Audit Program, and Technical Surveillance audits. Supporting any other duties within the role or tasks assigned from time to time. Your Skills and Expertise To set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications: Bachelor's Degree or higher (completed and verified) from an accredited institution AND five (5) years of experience in Regulatory Affairs & Medical Device experience in a private, public, government or military environment OR High School Diploma/GED (completed and verified prior to start) from an accredited institution and nine (9) years of experience in Regulatory Affairs & Medical Device in a private, public, government or military environment In addition to the above requirements, the following are also required: Three (3) years of experience with regulatory submissions which include: 510(k) submissions, EU MDR submissions, and/or other international medical device regulations and submissions Additional qualifications that could help you succeed even further in this role include: Advanced degree in Scientific, Engineering or Regulatory/Quality. Experience supporting 13485 and MDSAP audits. New Product Introductions (NPI) experience. Five (5) years of experience with regulatory submissions which may include: 510(k) submissions, EU MDR submissions, and/or other international medical device regulations and submissions. Work location: Remote in the United States Travel: May include up to 10% domestic/international Relocation Assistance: Is not authorized Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status). Supporting Your Well-being Solventum offers many programs to help you live your best life - both physically and financially. To ensure competitive pay and benefits, Solventum regularly benchmarks with other companies that are comparable in size and scope. Applicable to US Applicants Only:The expected compensation range for this position is $131,750 - $170,500, which includes base pay plus variable incentive pay, if eligible. This range represents a good faith estimate for this position. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate's relevant knowledge, training, skills, work location, and/or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental & Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences and Retirement Benefits, etc.). Additional information is available at: *************************************************************************************** of this position include that corporate policies, procedures and security standards are complied with while performing assigned duties. Solventum is committed to maintaining the highest standards of integrity and professionalism in our recruitment process. Applicants must remain alert to fraudulent job postings and recruitment schemes that falsely claim to represent Solventum and seek to exploit job seekers. Please note that all email communications from Solventum regarding job opportunities with the company will be from an email with a domain *****************. Be wary of unsolicited emails or messages regarding Solventum job opportunities from emails with other email domains. Please note, Solventum does not expect candidates in this position to perform work in the unincorporated areas of Los Angeles County.Solventum is an equal opportunity employer. Solventum will not discriminate against any applicant for employment on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status. Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly. Solventum Global Terms of Use and Privacy Statement Carefully read these Terms of Use before using this website. Your access to and use of this website and application for a job at Solventum are conditioned on your acceptance and compliance with these terms. Please access the linked document by clicking here, select the country where you are applying for employment, and review. Before submitting your application you will be asked to confirm your agreement with the terms.

GCI's Regulatory Analyst II will create, implement, and ensure GCI's compliance with regulations. Prepare monthly carrier access billings and pool/settlement reporting; monitor and maintain access minute reporting functions; prepare, maintain, and interface with regulatory agencies filings for state and interstate tariffs, rate postings, Federal Universal Service Fund, and the Alaska Universal Service Fund; assist in preparation of cost studies and network use analyses; perform other regulatory/financial work. Keep appraising any regulation changes on both the state and federal side and offer interpretation. Prepare company tariffs and rate postings under both federal and state regulations. ESSENTIAL DUTIES AND RESPONSIBILITIES AT ALL LEVELS: Regulatory Filing Preparation and Analysis: Read and interpret FCC, RCA, and other regulatory entity rules, regulations, and procedures. Analyze and offer recommendations in response to any upcoming regulatory issues. Seek out, notify, and coordinate with other personnel within the organization to ensure process creation and ongoing compliance. Prepare reports and filings with regulatory bodies to ensure accurate receipt of Universal Service fund support and pooled earnings. Create processes, interpret changes, and maintain accurate documentation regarding each filing and the regulation or rule driving it. Tariff/Posting Preparation: Audit, preparation and filing of access tariffs as well as tariff interpretations and quotes; maintenance of local and long-distance rate postings, terms, and conditions. Coordination with other departments to maintain compliance. Streamline and automated processes where necessary. Access Minute Management: Act as first point of contact for Local Exchange Carrier (LEC) CABs preparers. Manage trunk tables to ensure accurate access minutes are being captured and review monthly files sent to LECs. Work closely with IT Analysis to ensure data integrity. Calculate quarterly billing factors and maintain records sufficient for audit. Carrier Access Billing (CABs): Prepare monthly CABS billing and related analysis. Use reports from the CABs system as needed to analyze trends and monitor the integrity of the CABs bill. Follow-up and resolve any trend analysis anomalies. Reconcile and balance billing reports used for Connect America Fund (CAF) filings. File Network Access Fee (NAF) revenues, Intrastate minutes of use, and switched circuits in the Alaska Exchange Carriers Association (AECA) portal. COMPETENCIES: + ACCOUNTABILITY- Takes ownership for actions, decisions, and results; openly accepts feedback and demonstrates a willingness to improve. + BASIC PRINCIPLES - Interacts with people in a way that builds mutual trust, confidence, and respect; adheres to GCI's Code of Conduct for Employees - the Basic Principles. + COLLABORATION - Works effectively with others to accomplish common goals and objectives; maintains positive relationships even under difficult circumstances. + COMMUNICATION- Conveys thoughts and expresses ideas appropriately and professionally. + Ability to accurately communicate information virtually (i.e., Teams), over the phone, and in-person in a clear and concise manner to a range of audiences. + Ability to accurately read, write, and respond to business correspondence such as emails, chat messages, policies, procedures, reports. + Ability to multitask in a faced paced environment with successful results. + COMPLIANCE - Follows internal controls; protects confidential information; abides by GCI's Code of Business Conduct & Ethics. + CUSTOMER FOCUS - Demonstrates commitment to service excellence; gives high priority to customer satisfaction. + RELIABILITY - Consistently follows through on assigned tasks as expected; demonstrates timely attendance at meetings, training, and other work obligations. + RESULTS - Uses a combination of job knowledge, initiative, sound decision making, innovation, adaptability, and problem solving. + SAFETY & SECURITY - Supports a safe work environment by following all workplace safety rules and guidelines; complies with applicable Security policies and procedures. + TECHNICAL PROFICIENCY - Proficient computer skills and MS Office knowledge (e.g., Outlook, Teams, Word, Excel) to complete job duties effectively, such as using the company intranet and to accurately retrieve and input information into database or equivalents. Additional Job Requirements: Intermediate level analyst position. Must have a comprehensive understanding of telecommunications, and ability to follow documented procedures with no supervision. Works under moderate supervision and supports team. Requires ability to execute complex procedures. High degree of self-initiative and be able to prioritize and handle multiple tasks with independent decision-making. Individual must lead team members and effectively communicate directions. Minimum Qualifications: Required: *A combination of relevant work experience and/or education sufficient to perform the duties of the job may substitute to meet the total years required on a year-for-year basis + High School diploma or equivalent. + Bachelor's Degree in business administration, Finance, Economics, or related field.* + Minimum six (6) years of increasing responsibility in regulatory, compliance or related regulated industry experience. * Preferred: + Four (4) years of experience working in the telecommunications industry for mid- to large-size private business. + Other relevant telecom industry or job specific certifications. DRIVING REQUIREMENTS: + This position may require access to reliable transportation for occasional travel between retail store locations, offices, worksites, or other locations as needed. PHYSICAL REQUIREMENTS and WORKING CONDITIONS: + Work is primarily sedentary, requiring daily routine computer usage. + Ability to work shifts as assigned, work in standard office/home office setting, and operate standard office equipment. + Ability to accurately communicate information and ideas to others effectively. + Physical agility and effort sufficiently to perform job duties safely and effectively. + Ability to make valid judgments and decisions. + Available to work additional time on weekends, holidays, before or after normal work hours when necessary. + Must work well in a team environment and be able to work with a diverse group of people and customers. + Virtual workers must comply with remote work policies and agreements. The company and its subsidiaries operate in a 24/7 environment providing critical services to Alaskans and may need to respond to public health and safety matters or other business emergencies. Due to business needs employees may be contacted outside of the core business hours to respond to the immediate emergency. As such, you will be requested to provide emergency after-hour contact numbers, to include your home and cell phone numbers if you have those services. Culture, Engagement, and Connection: At GCI, we foster an environment where the unique perspectives of our employees, customers, and fellow Alaskans are celebrated. We add value to our community by nurturing and empowering each member of our workforce, ensuring equal opportunities for every Trailblazer. EEO: GCI is an equal opportunity employer. Qualified applicants are considered for employment without regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, marital status, mental or physical disability, veteran status, or any other status or classification protected under applicable state or federal law. DISCLAIMER: The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. All employees of GCI work in support of the GCI Mission Statement and Declaration of Principles which are located on the GCI Career page and Employee portal.