Regulatory administrator jobs near me - 170 jobs

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.

Duties will include but not be limited to preparation and submittal of oil and gas regulatory applications and notices of work, including the ability to permit special projects with minimal direction/supervision; coordination with Division personnel to secure data required for regulatory filings required by OH Regulatory agencies. Prepare and file state and federal Class II/VI UIC applications where applicable. Work with local, State and Federal regulatory agencies to obtain appropriate approvals and provide necessary information to the same in order to comply with the regulatory requirements of the associated project. Maintain various spreadsheets and files to facilitate tracking the regulatory process for reporting to management. The applicant must have 7+ years' experience in the operational regulatory field; well permitting and completion filing, with the majority of experience associated with oil and gas operations in OH. Must have a thorough knowledge of current State, Federal and local laws, rules and regulations related to oil and gas operations. Ability to maintain a high level of accuracy, focus on detail, and consistently meet deadlines when completing all applications, notices, and reports is essential. Must have good organizational, computer, communication and interpersonal skills. One must be able to work across all functional lines including operations, land, geology, and reservoir, and be able to handle themselves in a group setting, to proficiently answer regulatory questions across the board. Knowing and willingly reach out to other EOG regulatory personnel, or Legal Counsel to ensure the correct action is taken is a must. Attention to detail, like working with data and be proficient in Microsoft Office and Microsoft Excel is a necessity. A high school diploma or GED is required; however, a college degree is preferred. EOG Resources is an Equal Opportunity Employer, including Veterans and Disabled.

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

Shift: Monday through Friday, 8:00 AM - 5:00 PM (with some flexibility) 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. Lead and execute global regulatory strategies to ensure our client's investigational, new, and marketed products are developed and maintained in compliance with global regulatory requirements. Serve as a strategic advisor to clients, ensuring regulatory compliance, influencing key stakeholders, and optimizing business outcomes. Compensation: $150,000.00 - 175,000.00 per year Key Responsibilities: Regulatory Submissions: Author and compile CMC sections of regulatory applications, including INDs, IMPDs, CTAs, amendments, and annual reports. Documentation: Draft and maintain high-quality CMC regulatory documents such as Module 2 and 3 summaries, stability reports, and comparability protocols. Communication: Support regulatory interactions by preparing responses to CMC-related questions from FDA, EMA, PMDA, and other global health authorities. Strategy Implementation: Prepare and Lead Regulatory interactions for CMC regulatory strategies to support clinical trial initiation and advancement. Process Development: Contribute to the development of templates, processes, and workflows to support efficient and compliant CMC regulatory operations. Other duties as assigned. Ideal Candidate: B.A. / B.A./ M.S. / Ph.D. in biochemistry, chemistry, biology, or related pharmaceutical field with a minimum of 10+ years of experience in CMC /regulatory affairs Hands-on experience authoring and compiling CMC sections of INDs, IMPDs, CTAs, amendments, and related filings. Strong knowledge of global CMC clinical regulatory requirements and guidelines, including FDA, EMA, and ICH. Excellent attention to detail, technical writing, organizational, and communication skills. Ability to manage multiple deliverables and timelines in a fast-paced environment. Proficiency with regulatory document management systems. 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.

Regulatory and Government Affairs - Associate Director (NY / Remote) Entity: KBRA Holdings LLC Employment Type: Full-Time Location: New York, New York or Remote (Remote only in CA, CO, DC, FL, IL, MD, NJ, MA, NY, PA, SC, TX, VA) Summary: KBRA's Regulatory and Government Affairs team is seeking a highly motivated Associate Director to support the firm's engagement with regulators, policymakers, and industry stakeholders. This position offers a unique opportunity to participate in conversations at the intersection of financial regulation, capital markets, and public policy. The Associate Director will assist in monitoring regulatory and legislative developments, conducting policy research, and preparing materials for internal and external audiences. This position is ideal for candidates who have studied Public Policy, Political Science, Economics, Law, International Relations, Finance, or a related field and who have demonstrated experience in applying their research and analytical skills to real-world regulatory and policy issues. About the Job: Regulatory and Legislative Monitoring: Track and summarize relevant legislative, regulatory, and policy developments affecting credit rating agencies and the broader financial services sector. Policy Research and Analysis: Conduct in-depth research and draft analyses on key policy areas such as capital markets regulation, financial stability, ESG disclosure frameworks, and credit ratings oversight. Briefing Materials: Prepare policy briefs, internal memoranda, issue summaries, and talking points for senior leadership ahead of meetings with regulators, trade associations, and policymakers. Stakeholder Engagement: Support and participate in preparation for policy roundtables, industry consultations, and conferences involving government or regulatory representatives. Cross-Functional Collaboration: Work closely with teams across KBRA including Legal, Compliance, and Communications to maintain consistent and informed policy messaging. Special Projects: Contribute to strategic initiatives related to regulatory trends, public policy priorities, and global coordination efforts. You will be successful in this role if you possess: Bachelor's or Master's degree in Public Policy, Political Science, Economics, Law, International Relations, Finance, or a related field. Minimum four years of experience in financial regulation, public policy, or government affairs. Excellent research, writing, and analytical skills, with the ability to distill complex policy issues clearly and accurately. Strong organizational skills and attention to detail, and ability to manage multiple projects simultaneously. Ability to work both independently and collaboratively in a fast-paced professional environment. Proficiency with Microsoft Office Suite; familiarity with legislative tracking tools, regulatory databases, or financial market research platforms is a plus. Familiarity with Generative AI tools such as ChatGPT for research, data insights, and general productivity is a plus. What You will Gain: Direct exposure to the regulatory and policy landscape shaping the global credit rating industry. Opportunities to work with KBRA's experienced regulatory and government affairs professionals on meaningful policy issues. Insight into how a leading credit rating agency engages with regulators, legislators, and industry bodies. A deep understanding of how regulatory policy impacts capital markets and credit analysis. Skill development in policy analysis, stakeholder engagement, and cross-functional collaboration. A collaborative and mission-driven culture that values independence, integrity, and analytical excellence. Salary Range: The anticipated annual base salary range for this full-time position is $120,000 - $150,000. Offer amounts are determined by factors such as experience, skills, geography, and other job-related factors. Benefits: A flexible hybrid work schedule - Tuesdays, Wednesdays, Thursdays in the office Competitive benefits and paid time off Paid family and disability leave 401(k) plan, including employer match (100% vested) Educational and professional development financial assistance Employee referral bonus program About Us: KBRA is a full-service credit rating agency registered in the U.S., the EU and the UK, and is designated to provide structured finance ratings in Canada. KBRA's ratings can be used by investors for regulatory capital purposes in multiple jurisdictions. More Info: KBRA encourages applications from all qualified individuals without regard to race, color, religion, gender, sexual orientation, gender identity or expression, age, national origin, marital status, citizenship, disability, and veteran status or any other basis prohibited by federal, state or local law. #LI-KS1 #Remote

**Our mission** At Corza Medical, our mission is to champion surgical providers with remarkable service and exceptional products that save time, money, and effort. We are a passionate team guided by our core belief that you should never have to choose between performance, value, and a quality customer experience. We are here to support you every step of the way. **Our brand promise** We deliver a collaborative experience by working directly with the surgical community to ensure you get the exact surgical tools you need at the right time and the right price. + **Remarkable service:** A seamless, personal process designed around you and your needs. + **Trusted performance:** Our product family is the result of years of experience championing surgeons and listening to their expertise. + **Outstanding value:** No matter the surgical specialty, we deliver quality products for all markets. **Our people promise** Excellence is our Specialty and what makes us successful is our people. We are committed to fostering a positive, empowering and growth-oriented environment where all team members are encouraged to share their opinions and ideas. That means you will work alongside an accomplished and highly collaborative team that inspires commitment to our goal in attaining excellence in everything they do. **Job Purpose Summary** The Senior RA Specialist position is responsible for preparing regulatory submissions and registration documentation, providing quality and timely regulatory support to obtain marketing clearance/approval for new products and maintaining marketability of existing products. **What you will do** + Assist in the implementation of company's domestic and international regulatory submission strategies. + Manage multiple concurrent projects, balancing competing priorities and deadlines. + Develop and maintain submission trackers, readiness matrices, and compliance checklists to ensure operational efficiency. + Troubleshoot regulatory challenges and provide practical solutions to keep projects on track. + Provide mentorship and guidance to junior RA staff, fostering professional growth and team collaboration. + Review critical documents to assure completeness, and with supervision, will prepare responses to routine in-country representative or regulatory agency results. + Ensure the content, organization and overall quality of all regulatory documentation are adequate and sufficient to comply with local, regional and / or international regulatory requirements, commitments and agreements. + Development of tracking documents and follow-up to assure submissions are managed appropriately. + Perform the coordination and preparation of document package for regulatory submissions (US and international). + Compile all materials required in submissions, license renewal and annual registrations. + Keep abreast of regulatory procedures and changes. May have direct interaction with regulatory agencies on defined matters. + Represent regulatory affairs on project teams. + Develop and recommend strategies for earliest possible approvals of device applications. + Generate departmental procedures. + Ensure documents are apostilled, certified and legalized or notarized, as required. + Assess new and / or modified standards, regulations and / or laws and determine applicability to the organization and / or product. + Complete other related duties as required. + Conduct oneself consistent with company standards at all times during work hours or when acting as a representative of the company. **What you will need** + Bachelor's degree in a technical discipline, such as Engineering, Bio-Medical Engineering, Computer Science, Biology, Chemistry or related field. + Minimum 5 years of experience in Regulatory Affairs in the medical device industry. + Experience with regulatory registration and/or submissions in markets such as US, Canada, Japan, China, Korea, Taiwan and South America. + Experience with medical device regulations (21 CFR, MDR, MDSAP, ISO 13485) and Biologics License Applications (21 CFR) preferred. + Demonstrated success managing multiple projects and competing priorities in a fast-paced environment. + Experience mentoring or supervising junior staff. + Experience with Wound Care products preferred. + Experience in Quality Assurance or Quality Systems is strongly preferred. + Ability to communicate effectively both verbally and written. Effective and influential when working on teams, with solid negotiation skills when required to reach optimal decisions. + Ability to work on multiple scenarios of diverse scope where analysis of a situation or data requires evaluation of various factors. + Detail oriented with the ability to accomplish objectives with minimal supervision. + Travel Requirements - 15%+ In order to qualify for this position, applicants must be authorized to work for ANY employer in the US. We are unable to sponsor or take over sponsorship of employment Visa at this time. **Key Attributes** + **Resilient multitasker** - thrives under pressure and adapts quickly to shifting priorities. + **Strategic communicator** - able to translate regulatory complexity into clear, actionable guidance. + **Collaborative leader** - balances hands-on execution with team development. + **Detail-oriented executor** - ensures accuracy and compliance while meeting deadlines. **What we value** + **Customer First** - We deliver extraordinary experiences. + **Accountability** - We do what we say. + **Integrity** - We do what is right. + **Inspired** - We love what we do. + **One Global Team** -We before me, always. Join us today and **Excel@Corza** ! **_Corza Medical offers a competitive benefits package including medical, 401K, vacation and sick time, paternal leave and other benefits._** **_A reasonable estimate of the current pay range for this role is $100,000-$108,000/year. Further, pay is offered based on geographic location, internal equity, market data, applicant's job-related skills, commensurate experience, required licensures, certifications, and certain degrees._** **_Corza Medical is an equal opportunity employer. Corza Medical evaluates qualified applicants without regard to race, color, marital status, religion, sex, sexual orientation, gender identity, age, national origin, physical or mental disability, veteran status or other protected characteristics._** **_Notice To Third Party Agencies:_** **_Corza does not accept unsolicited resumes from recruiters, employment agencies, or other staffing services. Any unsolicited resumes, including those submitted to hiring managers or other business leaders, will become the property of Corza Medical and Corza Medical will have the right to hire that candidate without reservation - no fee or other compensation will be owed or paid to the recruiter, employment agency, or other staffing service._**

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

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 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: ********************************

At Anchorage Digital, we are building the world's most advanced digital asset platform for institutions to participate in crypto. Anchorage Digital is a crypto platform that enables institutions to participate in digital assets through custody, staking, trading, governance, settlement, and the industry's leading security infrastructure. Home to Anchorage Digital Bank N.A., the first federally chartered crypto bank in the U.S., Anchorage Digital also serves institutions through Anchorage Digital Singapore, Porto by Anchorage Digital, and other offerings. The company is funded by leading institutions including Andreessen Horowitz, GIC, Goldman Sachs, KKR, and Visa, with its Series D valuation over $3 billion. Founded in 2017 in San Francisco, California, Anchorage Digital has offices in New York, New York; Porto, Portugal; Singapore; and Sioux Falls, South Dakota. Learn more at anchorage.com, on X @Anchorage, and on LinkedIn. We are building a regulated infrastructure platform at the intersection of banking, markets, and digital asset ecosystems. The Global Analytics Team delivers quantitative, policy, and data-driven capabilities that empower business units to scale, govern, and satisfy supervisory expectations. We are seeking a highly motivated and analytical individual to join our Economic & Regulatory Analysis pillar, focused on capital, margin, liquidity, and supervisory readiness across banking and markets regimes. We have created the Factors of Growth & Impact to help Villagers better measure impact and articulate coaching, feedback, and the rich and rewarding learning that happens while exploring, developing, and mastering the capabilities and contributions within and outside of the Member of Global Analytics role:Technical Skills: Foundational capability in regulatory analysis across banking and markets frameworks, including ability to interpret statutes, rules, supervisory guidance, and industry standards. Familiarity with capital, liquidity and margin frameworks (e.g., initial margin, variation margin, netting, collateral eligibility). Understanding of risk measurement methods (e.g., stress testing, scenario analysis, backtesting) and regulatory capital concepts. Experience handling large datasets, applying statistical or econometric tools (e.g., Python, R) , conducting research and data analysis (e.g., SQL). Complexity and Impact of Work: Translate evolving banking and market regulations into actionable analytics, policy, and operational road-maps with limited supervision. Assist in the development and maintenance of capital, margin and liquidity methodologies aligned to regulatory expectations. Apply analytical rigor to capital, liquidity, and margin concepts; supports impact assessments and structured risk/capital analyses. Support licensing submissions, supervisory engagements, internal governance and business decision-making. Build repeatable frameworks and artifacts across regulatory, capital and margin domains, enabling the institution to scale and meet supervisory scrutiny. Organizational Knowledge: Has a deep knowledge of the strategy of Anchorage Digital and its various business lines. Understands how regulatory, capital, liquidity, and control expectations intersect with business model, product architecture, and operating processes. Builds working knowledge across Legal, Risk, Finance, Operations, and Product to translate requirements into scalable controls and workflows. Recognizes governance touchpoints, internal approval pathways, and key decision forums; ensures materials reflect decision-grade clarity. Communication and Influence: Demonstrates capability in writing, editing, and reviewing technical documents suitable for various contexts (e.g., regulatory or banking, internal or external stakeholders). Synthesizes complex regulatory concepts into concise, decision-ready narratives for senior stakeholders. Collaborates across teams, contributes to cross-functional initiatives, and guides colleagues or stakeholders in technical topics. Influences decision-making through structured recommendations, escalation of risk points, and disciplined documentation. You may be a fit for this role if you have: A bachelor's degree in economics, finance, public policy, or related field; advanced degree preferred. 3-5+ years in financial services, regulatory advisory, risk/capital functions, or regulatory agency. Familiarity with prudential standards (OCC/FRB) and derivatives/market frameworks (CFTC/SEC), and practical exposure to regulatory capital, margin frameworks, banking or derivatives markets. Strong analytical skills, including ability to handle large datasets and apply statistical or econometric tools. Exceptional written and verbal communication skills; able to distill complex concepts into actionable insights. High analytical rigor, cross-functional execution discipline, and attention to detail. Although not a requirement, bonus points if: You've kept up to date with the proliferation of blockchain and crypto innovations. You were emotionally moved by the soundtrack to Hamilton, which chronicles the founding of a new financial system. :) About Anchorage Digital: Who we are The Anchorage Village, what we call our team, brings together the brightest minds from platform security, financial services, and distributed ledger technology to provide the building blocks that empower institutions to safely participate in the evolving digital asset ecosystem. As a diverse team of more than 600 members, we are united in one common goal: building the future of finance by providing the foundation upon which value moves safely in the new global economy. Anchorage Digital is committed to being a welcoming and inclusive workplace for everyone, and we are intentional about making sure people feel respected, supported, and connected at work-regardless of who you are or where you come from. We value and celebrate our differences and we believe being open about who we are allows us to do the best work of our lives. Anchorage Digital is an Equal Opportunity Employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or veteran status. Anchorage Digital considers qualified applicants regardless of criminal histories, consistent with other legal requirements. “Anchorage Digital” refers to services that are offered either through Anchorage Digital Bank National Association, an OCC-chartered national trust bank, or Anchorage Lending CA, LLC a finance lender licensed by the California Department of Financial Protection and Innovation, License No. 60DBO-11976, or Anchorage Digital Singapore Pte Ltd, a Singapore private limited company, all wholly-owned subsidiaries of Anchor Labs, Inc., a Delaware corporation. Protecting your privacy rights is important to Anchorage Digital, and we work to maintain the trust and confidence of our clients when handling personal or financial information. Please see our privacy policy notices here.

Join a team where precision meets purpose. At Jubilant Radiopharma, we're advancing healthcare through innovation-and we need detail-driven professionals to help us stay compliant and operational. If you have a paralegal background and thrive on organization, accuracy, and problem-solving, this role is for you. About the Role As a Licensing & Regulatory Coordinator, you'll be the backbone of our compliance efforts, ensuring all federal, state, and local permits, licenses, and registrations are maintained without interruption. You'll research, draft, edit, and file critical documents, track renewal timelines, and keep our regulatory framework strong and reliable. What You'll Do * Partner with operations and regulatory teams to maintain and update licenses, permits, and registrations, including timely fee payments. * Serve as a trusted advisor by understanding business goals and aligning compliance strategies to support them. * Prepare filings, manage document workflows, and maintain accurate historical records of all licensing activities. * Handle multiple priorities with strong planning and analytical skills, leveraging technology for efficiency. * Respond to inquiries and provide guidance on operating policies to ensure consistency and compliance. * Participate in meetings to stay ahead of new requirements and regulatory changes. * Perform additional duties as needed to support smooth operations. What You Bring * Bachelor's degree in Business or related field (or equivalent experience). * 2-4 years in regulatory, compliance, or licensing roles-pharmaceutical or radiopharmacy experience preferred. * Advanced proficiency in Microsoft Office and online research tools; SAP experience is a plus. * Exceptional organizational skills, attention to detail, and ability to manage multiple deadlines. * Strong written and verbal communication skills. * Collaborative, customer-focused mindset. * Experience with pharmacy or radiopharmacy licensing is highly valued. Why Jubilant Radiopharma? * Be part of a mission-driven organization improving patient care worldwide. * Work in an inclusive, supportive environment that values diverse perspectives. * Opportunities for growth and professional development. Ready to make an impact? Apply today and help us keep healthcare moving forward. Candidates whose experience matches what Jubilant Radiopharma is seeking will be contacted directly for an interview. If candidates need assistance in applying for this position, please call ************. Candidates must successfully complete pre-employment drug screen and criminal background check. Individuals with Disabilities/Protected Veteran are welcomed. Thank you for your interest in joining the Jubilant Radiopharma team!

About Us OpenFX is on a mission to move money as freely as data, unrestricted by time zones, banking hours, or legacy systems. We are building the infrastructure that will power the next generation of cross-border payment systems for institutions. The team's execution has been exceptional, and we're scaling at a remarkable pace. Our stellar early team comes with experience in companies like J.P. Morgan, Goldman Sachs, FalconX, Paypal, Affirm, Polygon, Kraken, Nium & others. We're backed by Accel, Lightspeed, NfX and other top-tier investors. Role Overview We are seeking a Head of Americas Licensing and Regulatory Affairs to join our dynamic team. The role will be responsible for driving our acquisition of U.S. state money transmitter licenses and subsequent management of those licenses and our relationships with U.S. state regulators, as well as the acquisition of other licenses to support the rapid growth of our business in the U.S., Canada and Latin America. This role is crucial for enabling our global expansion while maintaining regulatory compliance and strong relationships with regulatory authorities. Key Responsibilities: Licensing Acquisition & Maintenance Complete execution of pending US state money transmitter license (MTL) applications: Complete preparation, coordination, and submission of MTL applications across all required US states, managing multiple applications simultaneously through approval Drive scoping and execution of additional license applications in the Americas: Prepare and submit Money Services Business (MSB) registration in Canada, obtain required U.S. crypto/virtual currency licenses, and secure any required licenses across key Latin American markets. Coordinate with external counsel and consultants: Manage relationships with licensing consultants and outside counsel to ensure high-quality, cost-effective support aligned with business needs Manage license maintenance activities: Oversee all post-licensing obligations including renewals, amendments, quarterly/annual reporting, surety bond management, net worth requirements, and permissible investment compliance Regulatory Relations and Compliance Operations Serve as primary regulatory contact: Act as OpenFX's main point of contact with state banking departments, FinCEN, and other US regulators, as well as FINTRAC (Canada) and Latin American financial authorities Build and maintain regulator relationships: Establish positive, proactive relationships with key regulatory bodies, positioning OpenFX as a compliant and transparent operator Manage regulatory inquiries and examinations: Lead preparations for and responses to regulatory examinations, audits, inquiries, and requests for information from state and federal regulators Prepare regulatory submissions: Draft, review, and submit all regulatory filings, notifications, reports, and correspondence with accuracy and within required timelines Prepare and manage regulatory reports and filings: Coordinate with Finance and other internal stakeholders to submit quarterly, semi-annual, and annual financial and operational reports required under various licenses Cross-Functional Collaboration Support market expansion: Work with internal teams to identify regulatory requirements for new markets and develop paths to licensure Maintain policies and procedures: Review and update regulatory policies, procedures, and compliance manuals to reflect current requirements Build and develop the team: As the business scales, recruit and manage licensing and regulatory professionals What we are looking for Required Qualifications 7+ years of experience in regulatory licensing, regulatory affairs, or regulatory compliance within financial services, fintech, or payments companies Proven track record of successfully obtaining and maintaining financial services licenses, particularly US state money transmitter licenses Strong knowledge of US state money transmission regulatory frameworks, including application processes, surety bond requirements, net worth rules, and examination procedures Regulatory filing expertise: Demonstrated experience preparing and submitting regulatory reports, notifications, and responses to regulatory inquiries Regulator relationship experience: Track record of successfully interfacing with state banking departments, FinCEN, and other financial regulators Exceptional project management skills: Ability to manage multiple complex, time-sensitive licensing applications and compliance obligations simultaneously Outstanding written communication skills: Experience drafting regulatory submissions, applications, policies, and correspondence to regulators Meticulous attention to detail: Strong analytical skills with ability to navigate complex regulatory requirements and ensure accuracy in all submissions Collaborative approach: Commitment to teamwork and ability to work effectively with cross-functional teams and external advisors Bachelor's degree required; JD preferred What helps you stand out: Experience in cross-border payments, FX, or crypto industries Experience with crypto/digital asset licensing (e.g., NY BitLicense, state virtual currency licenses) Experience with international licensing (Canada MSB registration, Latin American licenses) Prior work at a high-growth fintech or payments startup managing rapid licensing expansion Existing relationships with state regulators, CSBS, or Money Transmitter Regulators Association (MTRA) Familiarity with RegTech tools and automation for regulatory compliance and reportin What We Offer Competitive salary and benefits package Impact: Own the licensing function at a critical growth stage and directly enable business expansion Growth: Opportunity to build a function and help scale a successful high-growth company Learning: Opportunity to work in a fast-paced startup at the forefront of fintech innovation. Culture: Collaborative team environment with emphasis on personal and professional growth Mission: Help build the future of global financial infrastructure We are committed to building a diverse and inclusive workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Find your purpose as a Financial and Regulatory Analyst at CentraCare. The Financial and Regulatory Policy Analyst serves as a cross-functional expert supporting financial analysis, payer policy review, and regulatory compliance. This role is responsible for evaluating the financial and operational impact of payer policies, government reimbursement regulations, and healthcare legislation. The analyst partners with managed care, revenue cycle, government reimbursement, compliance, and clinical operations teams to ensure alignment with payer requirements, optimize reimbursement, and mitigate regulatory risk. Schedule: Full-time 72 hours every 2 weeks Hours between Monday - Friday 8:00a-5:00p CST Fully remote Pay and Benefits: Starting pay begins at $63,747.33 per year and increases with experience. Salary range: $63,747.33-$95,642.90 per year Salary range is based on a 1.0 FTE, reduced FTE will result in a prorated offer rate We offer a generous benefits package that includes medical, dental, flexible spending accounts, PTO, 401(k) retirement plan & match, LTD and STD, tuition reimbursement, discounts at local and national businesses and so much more! Qualifications: Bachelor's degree in Finance, Health Administration, Public Health, Economics, or related field or 5+ years of experience in financial analysis, strong report-building skills, payer relations, or regulatory affairs in a healthcare environment. Understanding of Medicare and Medicaid payment systems, managed care contracts, and payer policies required. Proficiency in Excel and financial modeling; ability to interpret large datasets required. Familiarity with EHR and revenue systems (e.g., Epic, Lawson, Strata, or similar) preferred. Experience with payer audits, prior authorization processes, and coverage policy review preferred. Strong analytical, report creation, and critical thinking skills. Clear written and verbal communication. Regulatory and policy acumen. Detail orientation with the ability to synthesize complex information. Collaboration and stakeholder engagement Core Functions: Payer Policy & Regulatory Intelligence Monitor and interpret payer policy updates, government reimbursement rules (e.g., Medicare, Medicaid, commercial plans), and legislation impacting financial performance. Analyze changes in payer coverage determinations, billing guidelines, and authorization policies to assess impact on access, documentation, and reimbursement. Collaborate with internal stakeholders to implement payer policy changes and ensure compliance across the revenue cycle and clinical departments. Identify opportunities for revenue enhancement and cost reduction through proactive management of payer policies. Financial Analysis & Forecasting Build and maintain financial models to forecast the revenue impact of regulatory or payer policy changes. Analyze variances in net revenue, denials, and reimbursement trends related to policy shifts and provide regular reports to the HealthCare Affordability Committee. Support budget planning and value-based contract modeling by incorporating regulatory and policy data. Develop metrics to track policy compliance, identify gaps, and propose solutions to improve processes and outcomes. Document and communicate findings, recommendations, and action plans to the HealthCare Affordability Committee. Regulatory Compliance & Reporting Track regulatory requirements from CMS, state Medicaid agencies, and commercial payers. Collaborate with compliance teams and revenue integrity teams to implement and maintain internal controls and audits to minimize risk. Collaborate with payer relations to address any payer-policy-related issues. Monitor adherence to payer policies across the organization. Partner with clinical and operational teams to ensure policy changes are implemented efficiently and effectively. Collaborate with the legal department to review and interpret contracts, agreements, and regulations. Communicate effectively with payers to clarify policy details and resolve disputes. Work closely with the revenue cycle management team to optimize claims processing and reimbursement. Cross-Functional Collaboration Act as a liaison between Finance, Compliance, Managed Care, Revenue Cycle, and Clinical Operations teams. Analyze clinical vendor reimbursement assumptions. Deliver policy summaries and financial impact briefs to operational leaders, with clear recommendations. Support stakeholders on new or updated payer policies and regulatory requirements. CentraCare has made a commitment to diversity in its workforce and all individuals, including, but not limited to, individuals with disabilities, are encouraged to apply. CentraCare is an EEO/AA employer.

Job Description 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.

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details Cencora Pharmalex is one of the leading service providers for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance. The success of our company resides in the expert knowledge and high motivation of our employees. Working for Pharmalex means being creative and adaptive. Our culture of continuous learning and commitment to diversity and inclusion creates an environment that allows you to build your skills and career. This role will provide accountability for the execution of operational tasks in the Regulatory practice area. This is a remote based role in the United States. Manages the preparation, assembly, publishing, and submitting of US and Canadian regulatory applications on behalf of PharmaLex clients. Supports key regulatory affairs consultants, by providing expertise and innovative solutions to clients and internal teams on regulatory strategy, process, filing, best practices, etc. for a broad range of product types and indications. Drafts and manages regulatory submissions Drafts and manages drug listing submissions, establishment registration submissions and preparation of SPL files. Coordinates regulatory fee payments on behalf of client. Maintains knowledge of changing regulatory requirements and advises teams as appropriate (Regulatory Intelligence). Liaises with regulatory authorities on behalf of clients (e.g., US Agent). Builds, develops and maintains working relationships with clients. Conducts issue resolution, communicates with the client and their functional areas to ensure that all issues are resolved in a compliant manner. Performs basic document management tasks including file transfer, storage, tracking, and archival. Maintains familiarity with current global regulatory submission standards as well as departmental procedures. Other duties as assigned. Education: Bachelor's Degree and 3-5 years' experience in Regulatory Affairs; or equivalent combination of education and experience. Experience: Experience working in the pharmaceutical industry. Ability to prioritize and drive multiple projects. Ability to train and support junior/new colleagues in daily activities; ability to lead small project with clearly defined scope. Understanding of FDA and Canadian Regulatory Affairs procedures, submission formats as well as industry standards and guidelines. Previous hands-on experience with managing and preparing original applications, amendments, supplements, annual reports, etc. for various application types including IND/CTA, ANDA/NDS/NDA/BLA. Ability to maintain confidentiality and responsive to client needs. Ability to adapt under regularly changing conditions. Outstanding organization, analytical, and problem-solving skills. Excellent written, verbal and presentation communication skills. Skills: High attention to detail. Technical writing capabilities Experience in Microsoft Office as well as regulatory systems (e.g., document management systems, RIM systems etc.) #LI-AT2 What Cencora offers We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members' ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. For details, visit ************************************** Full time Equal Employment Opportunity Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law. The company's continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory. Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call ************ or email ****************. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned Affiliated CompaniesAffiliated Companies: PharmaLex US Corporation

Job Description At Canopy Life Sciences, we are leading the way in advancing healthcare through innovation, collaboration, and a steadfast commitment to excellence. Our Regulatory Affairs division is made up of dedicated professionals who thrive in a dynamic, fast-paced environment, and we are seeking like-minded individuals to join our growing team. As an Associate Director to Director, Regulatory Affairs Advertising & Promotion, you will provide strategic, expert guidance on the advertising and promotion of assigned products, balancing regulatory requirements with the business needs and objectives of our clients. Your ability to anticipate challenges, offer innovative solutions, and foster strong relationships with both internal and external stakeholders will be key to your success in this role. This is a Remote position. Responsibilities include: Act as the primary Regulatory expert within an assigned clients Medical, Legal, and Regulatory (MLR) team, providing balanced strategic counsel and tactical support on both commercial and development programs. Conduct solutions-oriented and collaborative review and approval of all advertising and promotional materials, disease-awareness, scientific publications, training, and medical education materials and programs throughout an assigned products lifecycle. Maintain up-to-date knowledge of FDA laws, regulations and guidance documents, as well as the compliance environment as it relates to the advertising and promotion of pharmaceutical products and medical devices and advise teams as appropriate. Support the review of proposed updates to package inserts/labeling, offering input on potential promotional messages and claims. Collaborate with teams to help integrate relevant labeling changes into product promotional materials as needed. Support a variety of Regulatory Affairs initiatives within the Canopy Life Sciences Regulatory Affairs department related to ongoing process improvement, as assigned. Qualifications for this position include: At least 5 years of pharmaceutical/medical device advertising and promotional regulatory review. Ability to work independently in a remote role with minimal oversight. Proven ability to manage multiple priorities simultaneously, maintaining focus and meeting deadlines in a fast-paced environment while balancing diverse tasks and responsibilities. Strong team-oriented mindset with a collaborative attitude, able to work effectively with internal and external cross-functional teams to achieve common goals and drive successful outcomes. Bachelors degree (advanced degree in a science discipline preferred) As a part of our full-time team, you are eligible for our Comprehensive Benefits including: Medical, Dental and Vision Insurance Disability Insurance and Life Insurance 401(k) program with company match A balanced approach to work-life that offers a generous PTO program and Holidays. This is a remote position.

**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

About Wing: Wing offers drone delivery as a safe, fast, and sustainable solution for last mile logistics. Consumer appetites for on-demand services are increasing, but current delivery methods are inefficient, costly, and contribute to road accidents and air pollution. Wing's fleet of highly automated delivery drones can transport small packages directly from businesses to homes on-demand, in minutes. We design, build, and operate our aircraft, and offer drone delivery services on two continents. Our technology is designed to be easy to integrate into existing delivery and logistics networks, offering a scalable drone delivery solution for a broad range of businesses. Wing is a part of Google's parent company, Alphabet, and our mission is to create the preferred means of delivery for the planet. If you're ready to do the greatest work of your life, come join us. About the Role: Wing is looking for an Regulatory Lead, Operator to join our Global Aviation Regulatory Team. This role is based remotely in the US and reports to the Global Aviation Regulatory Lead. You will be responsible for leading Wing's regulatory strategy for the development, approval, and sustainment of our operational authorizations worldwide. Additionally, the Aviation Regulatory Lead will play a key role in the deployment of operator-facing system changes, evolving procedures and training, and expansion of operational capabilities. The ideal candidate will bring a deep understanding of today's uncrewed aircraft systems operational regulations in the US and around the globe along with emergent rulemaking that may impact Wing's future operations. The successful candidate will utilize this knowledge and expertise to provide leadership for Wing's future operator regulatory compliance strategy. This position will work closely with the flight operations teams to ensure compliance with applicable regulations but also develop innovative approaches to support our drone delivery business case. This role requires excellent written and verbal communication skills and the ability to collaborate with cross-functional teams. Ideal candidates have a passion for aviation and technology and are eager to learn and search for solutions in a dynamic and constantly evolving environment. What You'll Do: Lead the development, submission, and defense of comprehensive Operating Safety Cases to secure operational authorizations (e.g., Air Operator Certificate for the US, Specific Category approvals in the UK and EU, etc.) and airspace access (e.g., BVLOS/airspace waivers, special flight authorizations) from aviation regulators worldwide. Collaborate closely with other key engineering and operational stakeholders in the deployment of operator-facing system changes, evolving procedures and training, and expansion of operational capabilities. Interface routinely with various stakeholders across the company to ensure that all stakeholders understand the evolving regulatory environment and its impact on Wing's activities. Collaborate with other members of the aviation regulatory team supporting their respective functions for Wing's operations around the world. Actively participate in the development of industry consensus standards related to the functional domain of expertise. Proactively stay up-to-date with evolving regulations related to the functional domain of expertise, while developing and proposing alternative approaches to enable the company's innovative systems to keep on pioneering the drone delivery market. What You'll Need: Bachelor's degree in aviation, engineering,or a related field, or relevant technical experience. A Master's degree in aviation, engineering, or a related field is a plus. Minimum 12+ years of experience in aviation regulatory affairs, or a similar role, with a strong focus on air carrier operations (e.g. Part 135) or advanced UAS/drone operations. Proven track record of successfully securing and managing complex operational and airspace authorizations from major global aviation regulators (e.g., FAA Part 135, EASA/CASA/UK SORA, etc.). Excellent communication and collaboration skills to work effectively with cross-functional teams, with the ability to articulate complex technical and regulatory concepts clearly to regulators and technical teams. Startup mentality, resourceful and resilient with the ability to get things done in dynamic circumstances. Ability to travel nationally and internationally (as needed). The US base salary range for this full-time position is the salary range below + bonus + equity + benefits. Wing's salary ranges are determined by role, level, and location. Your recruiter can share more about the specific salary range for your location during the hiring process. Salary Range$134,000-$259,000 USD Wing is an equal opportunity employer and it is Wing's policy to comply with all applicable national, state and local laws pertaining to nondiscrimination and equal opportunity. Employment at Wing is based solely on a person's merit and qualifications directly related to professional competence. Wing does not discriminate against any employee or applicant because of race, creed, color, religion, gender, sexual orientation, gender identity/expression, national origin, disability, age, genetic information, veteran status, marital status, pregnancy or related condition (including breastfeeding), or any other basis protected by law. If you have a need that requires accommodation during the interview process due to a disability or special need, please let us know by completing our Candidate Accommodations Request Form.

Recruitment Fraud Alert We've learned that scammers are impersonating Commvault team members-including HR and leadership-via email or text. These bad actors may conduct fake interviews and ask for personal information, such as your social security number. What to know: Commvault does not conduct interviews by email or text. We will never ask you to submit sensitive documents (including banking information, SSN, etc) before your first day. If you suspect a recruiting scam, please contact us at ****************************** About Commvault Commvault (NASDAQ: CVLT) is the gold standard in cyber resilience. The company empowers customers to uncover, take action, and rapidly recover from cyberattacks - keeping data safe and businesses resilient. The company's unique AI-powered platform combines best-in-class data protection, exceptional data security, advanced data intelligence, and lightning-fast recovery across any workload or cloud at the lowest TCO. For over 25 years, more than 100,000 organizations and a vast partner ecosystem have relied on Commvault to reduce risks, improve governance, and do more with data. The Opportunity... Commvault is seeking a Regulatory Compliance Associate with a focus on Privacy and AI Governance to support the operational execution and continuous improvement of our global compliance programs. This role is ideal for a compliance professional with strong hands-on experience who can independently manage workflows, partner cross-functionally, and help mature privacy and AI governance operations at scale. What you'll do... Own and execute key operational workflows across privacy and AI governance, ensuring consistency, timeliness, and audit readiness. Independently manage data subject rights requests (DSRs), including intake, coordination, tracking, and response support. Support and coordinate privacy impact assessments (PIAs/DPIAs) and AI risk assessments, including documentation and follow-ups. Operationalize global privacy and AI regulatory requirements (e.g., GDPR, CCPA, EU AI Act) into repeatable processes and guidance. Maintain and continuously improve Privacy & AI compliance documentation, including policies, procedures, playbooks, and internal guidance. Support partnerships with product, engineering, security, and legal teams to embed privacy-by-design and responsible AI-by-design practices. Manage Privacy & AI compliance trackers, repositories, and tooling to ensure visibility, accountability, and reporting accuracy. Support third-party, vendor privacy, and AI compliance assessments, including documentation review and remediation tracking. Assist with regulatory inquiries, audits, and internal reviews by coordinating input and preparing supporting materials. Develop and deliver training content, enablement materials, and communications to support privacy and AI governance awareness. Track operational metrics and identify process gaps or opportunities for program improvement. Support additional initiatives across privacy, AI governance, and broader regulatory compliance as needed. Who you are... 1-3 years of professional experience in regulatory compliance, privacy operations, legal operations, or governance roles. Strong working knowledge of global privacy regulations (e.g., GDPR, CCPA) with practical exposure to AI governance or emerging technology risk. Demonstrated experience running compliance workflows end-to-end with minimal supervision. Operational mindset with the ability to translate regulatory requirements into scalable processes. Strong organizational and project management skills with excellent attention to detail. Excellent written and verbal communication skills, including drafting operational documentation and stakeholder guidance. Comfort working cross-functionally with technical and non-technical teams. Experience with compliance tools, trackers, or regulatory management systems is a plus. Relevant certifications (e.g., CIPP/E, CIPP/US, CIPM) are preferred but not required. You'll love working here because... Continuous professional development, product training, and career pathing An inclusive company culture, opportunity to join our Employee Resource Groups (ERGs) Generous benefits supporting your health, financial security, and work-life balance Employee stock purchase plan (ESPP) Ready to #makeyourmark at Commvault? Apply now! LI-PK1 LI-Remote Thank you for your interest in Commvault. Reflected below is the minimum and maximum base salary range for this role. At Commvault we use broad salary ranges in our job postings to reflect the diverse levels of expertise and experience among our candidates and is not reflective of the total compensation and benefits package. The specific salary offered will be determined based on your unique qualifications, including your relevant experience, skills, and the value you bring to the role. While the range provides a general idea of the compensation, it is important to note that placements within the range are not automatic and will be carefully considered to ensure a fair and competitive offer. We are committed to rewarding talent and experience. Pay Range$54,400-$120,750 USD Commvault is an equal opportunity workplace and is an affirmative action employer. We are always committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status and we will not discriminate against on the basis of such characteristics or any other status protected by the laws or regulations in the locations where we work. Commvault's goal is to make interviewing inclusive and accessible to all candidates and employees. If you have a disability or special need that requires accommodation to participate in the interview process or apply for a position at Commvault, please email accommodations@commvault.com For any inquiries not related to an accommodation please reach out to ******************************. Commvault's Privacy Policy

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.