Regulatory affairs manager work from home jobs

The Manager, Regulatory Affairs CMC is responsible for supporting and executing Regulatory CMC strategies in collaboration with cross-functional teams. This role manages CMC-related global regulatory submissions and Health Authority interactions to meet the project timelines for the assigned projects. This is a remote-based position located in the United States. Responsibilities: Support the development and implementation of Regulatory CMC strategies, including reviewing / authoring CTD CMC sections for assigned projects to ensure timely, high-quality global submissions for investigational, market, and post-approval applications Assist in preparing responses to Health Authority CMC questions, pre-meeting packages, and interactions for assigned projects Coordinate with the CMC team and other stakeholders to ensure timely submission of regulatory documents by tracking progress of document preparation Collaborate with cross-functional teams, especially CMC and Quality groups, to assess regulatory impact on CMC-related issues Contribute to regulatory risk assessment, identify key Regulatory CMC issues, and support mitigation activities throughout the product lifecycle Participate in developing internal Regulatory CMC guidance and working instructions Ensure proper Regulatory CMC assessment and actions are taken for recalls or product complaints during the product lifecycle Provide Regulatory CMC review for clinical protocols and investigator brochures for assigned projects Requirements Bachelor's degree in scientific disciplines required with expertise in at least one area in pharmaceutical development (chemical process, formulation, manufacturing, QC, QA, etc), MS/PhD is preferred Minimum of 5 years of related pharmaceutical or biopharmaceutical industry regulatory CMC experience Experience in leading the preparation of CMC modules to support CTA, NDA/MAA submissions, and subsequent responses to HA queries Expertise of ICH requirements and US/EU regulatory requirements Experience with regulatory CMC requirements for EU markets and GMP regulation Experience in authoring complex technical documents, CTD M2 and M3 sections, and life cycle management Experience with Veeva system preferred Excellent oral and written communications skills with attention to detail Strong project management skills, including coordinating teams and managing timelines for regulatory submissions Ability to demonstrate Elevar's core values by holding ourselves and each other accountable for the work we do, taking time to collaborate effectively while working remotely, making space or ingenuity in work and thought, and staying grounded in compassion The anticipated annual base salary range for this role is $125,000 to $160,000. Final compensation depends on multiple factors including but not limited to, relevant experience, skillset, depth and breadth of knowledge, internal equity, and external market factors. Elevar Therapeutics is a rapidly growing biotech company that offers competitive wages and benefits package including medical, dental, vision, time off, a retirement plan, and other voluntary benefits for employees. #LI-REMOTE

Job TitleSenior Regulatory Affairs Manager- REMOTE Location(s) US Remote - CT, US Remote - FL, US Remote - GA, US Remote - MA, US Remote - NC, US Remote - NJ, US Remote - VA About Us Revvity is a developer and provider of end-to-end solutions designed to help scientists, researchers, and clinicians solve the world's greatest health challenges. We pair the enthusiasm of an industry disruptor with the experience of a longtime leader. Our team of 11,000+ colleagues from around the globe are vital to our success and the reason we're able to push boundaries in pursuit of better human health. Find your future at Revvity Please note: This is a customer-funded position. Continued employment is contingent upon the availability of customer funding. Supports North America Regulatory activities Ensure timely preparation and completion of technical file submissions for in vitro diagnostic devices (assays, instruments, software) to meet project and business needs Ensure participation on cross functional project teams to provide strategic and tactical guidance to meet regulatory requirements, Develop North America regulatory strategies plan for submission for IVD products Assess changes to product, manufacturing processes, labeling affecting IVD products and communicate to global Regulatory and project teams for impact assessment Support global Regulatory teams and/or in-country dealers/representatives with regulatory registrations of IVD products Maintain up-to-date knowledge of IVD regulations and applicable guidance, monitor development of regulations and communicate impact to the business Provide input and feedback on clinical study protocols to ensure regulatory requirements are incorporated Support CE marking activities for IVD products and other market clearance for products manufactured globally Review and approve promotional materials and product labeling Support importation/exportation permitting activities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities of this job at any time. Basic Qualifications: Bachelor's Degree in a STEM field 6+ years of experience in a regulatory role supporting the Americas region and international registrations (US 510(k), PMA, DE NoVo submissions) OR Master's or PhD degree in a STEM field 4+ years of experience in a regulatory role supporting the Americas region and international registrations (US 510(k), PMA, DE NoVo submissions) Preferred Qualifications: Travel as circumstances dictate Excellent understanding of regulations and guidance documents required in Americas region RAC certified Excellent interpersonal, verbal and written communication skills (in English) Excellent time management, organizational, negotiation, and problem-solving skills Ability to work independently and in a matrixed organizational structure, developing strong relationships with peers and levels of management Compensation range: The annual base salary range for this full-time position is $140-150,000. This range reflects the minimum and maximum target for a new hire in this position. The base pay actually offered to the successful candidate will take into account internal equity, work location, and additional factors, including job-related skills, experience, and relevant education or training. Your recruiter can share more about the specific salary range for your preferred location during the hiring process. Please note that base pay is only one part of our total compensation package and is determined within a range. This range allows for the successful candidate to have an opportunity to progress within the position and develop at our company. This base pay range does not take into account bonuses, equity, or other benefits which may be applicable and are dependent on the level and position offered. #LI-CH1 What do we offer? We provide competitive and comprehensive benefits to our employees. Below are some highlights of our benefits: Medical, Dental, and Vision Insurance Options Life and Disability Insurance Paid Time-Off Parental Benefits Compassionate Care Leave 401k with Company Match Employee Stock Purchase Plan Learn more about Revvity's benefits by visiting our Bswift page. Log-In instructions are provided towards the bottom of the Bswift page. *For benefit-eligible roles only. Part-time and temporary roles may not be eligible for all benefits listed. Please reach out to your recruiter for more information. Revvity is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to any characteristic or status protected by applicable federal, state, and/or local laws. If you are an applicant with a disability that requires reasonable accommodation to complete any part of the application process or are limited in the ability-or unable to use-the online application system and need an alternative method for applying, you may contact ********************.

At Thorne, we work to deliver high-quality, science-backed solutions to empower individuals to take a proactive approach to their well-being. Each day begins with a mission to help others discover and achieve their best health. We count on our team members to challenge and push the boundaries to make that happen. At Thorne, you'll be joining a team of more than 750 passionate individuals committed to our cause of providing superior health solutions at every age and life stage. Position Summary: The Manager, Scientific Affairs will be a key player in the Scientific Affairs team as part of the greater Medical Affairs department. They will serve to support integration of scientific discovery and implementation of new product development. This individual will be responsible for evaluating ingredient supplier clinical studies to ensure the scientific rigor and standard required for Thorne innovation. This individual will possess a high level of knowledge in dietary supplement ingredients, sourcing, and utilization. As part of the Scientific Affairs team, they will ensure the transition of scientific and medical claims discovery to the Medical Affairs team for substantiation. This individual will support the collaboration between the greater Research and Development functions of the company and the commercialization teams within Medical Affairs, Sales, and Marketing. Successful candidates for this role will have deep expertise in vetting scientific literature for validity, accuracy, regulatory qualification, and value to company product strategies. This is a remote position. Responsibilities * Integral to the day-to-day activities of the Scientific Affairs team, including ingredient research, literature reviews and dossier development. * Provides support to the greater Scientific Affairs team by coordinating meetings, managing calendars, tracking new ingredient inquiries, supplier communications, and project status. * Assists in the organization and maintenance of Scientific and Medical Affairs templates, scorecards and additional in-house tools. * Prepares and organizes materials for internal presentations and supports ongoing data tracking needs * Independently functions as an integral member of the Scientific Affairs team in creating a pipeline of new ingredients for consideration in new product development and existing product reformulations. * Provides scientific expertise and input in communicating product use to internal stakeholders across departments. * Supports the creation of claims dossier outlines with an organized and efficient handoff to the Medical Affairs team to finalize claims substantiation. * Establishes and maintains an extensive contact and networking system of innovative ingredient suppliers who meet the Company's quality standards in collaboration with the greater R&D team. * Provides flexible support across Scientific and Medical Affairs projects as needed. * Supports the strategy for Thorne to be recognized as a leader in product science, quality and innovation. * Provides strategic oversight regarding industry trends and new developments with the goal of supporting new business and creating strategic plans that drive integration of the offerings of the company. * Participates in and supports new products, services, and business development initiatives that generate potential revenue creation and growth. * Ensures open and proactive communication between Research & Development, Medical Affairs, Sales, Marketing and other company representatives. What You Need * Bachelor's degree required in nutrition, chemistry, biology, or related field; Master's degree or equivalent research experience preferred. * Deep understanding and ability to critically assess scientific literature for accuracy, rigor, and clinical application. * Comprehensive understanding of emerging trends in the dietary supplement marketplace, and how they may relate to promotional and clinical practices. * Candidates with dietary supplement experience from high-quality, science-first companies will be prioritized. * Highly organized, proactive and capable of balancing both scientific detail and administrative execution * High level of nutritional product knowledge and appropriate use in new product development. * Demonstrates ability to develop and deliver upon business objectives. * Ability to build, develop, motivate and manage high-performance teams. * Comfort with and extensive experience interacting with others at all levels within and outside of the Company. What We Offer * Competitive compensation * 100% company-paid medical, dental, and vision insurance coverage for employees * Company-paid short- and long-term disability insurance * Company- paid life insurance * 401k plan with employer matching contributions up to 4% * Gym membership reimbursement * Monthly allowance of Thorne supplements * Paid time off, volunteer time off and holiday leave * Training, professional development, and career growth opportunities Thorne is the leader in science-backed health and wellness solutions committed to helping individuals live healthier longer. As the top recommended clinical brand by healthcare practitioners, Thorne offers a comprehensive range of products including nutritional supplements and health tests designed to meet the unique needs of individuals at every stage of life. Founded in 1984, Thorne products are formulated with the highest-quality ingredients, supported by clinical research, and rigorously tested to ensure purity, potency, and efficacy. Thorne is trusted by 47,000+ health-care professionals, thousands of professional athletes, more than 100 professional sports teams, multiple U.S. National Teams, and more than five million consumers. For more information, visit Thorne.com. THORNE IS AN EQUAL OPPORTUNITY EMPLOYER #LI-SC1

About Civica: Critical shortages of essential generic injectable drugs are an ongoing crisis in U.S. healthcare and have reached an all-time high. Over 300 essential medications are currently reported to be in shortage, according to industry and FDA reports. Shortages put patients at risk and waste hospital resources. Civica is a market-based nonprofit solution created in 2018 by health systems and philanthropies for the express purpose of preventing and mitigating drug shortages. Today, nearly 60 health systems have joined Civica, representing over 1,400 hospitals and approximately one-third of all U.S. hospital beds. Civica has also supplied the U.S. Department of Veteran's Affairs, the U.S. Department of Defense and the U.S. Strategic National Stockpile with essential medicines. Civica currently supplies medicines to health system members in 49 states. Civica's mission has expanded beyond the hospital setting to reach consumers directly through CivicaScript, which is dedicated to making quality outpatient generic medicines affordable and available. CivicaScript works with trusted manufacturing partners to develop quality generic medicines and has forged partnerships with like-minded payors, pharmacy benefit managers and pharmacies to enable significant cost savings to be passed along to their customers. Civica's new 140,000 square foot state-of-the-art manufacturing facility in Virginia will soon produce a steady supply of more than three dozen sterile injectables, all drugs that are currently in or near shortage. The plant will also produce affordable biosimilar insulins, ensuring all Americans have access to lower cost, quality insulins, regardless of their insurance status. The Civica Foundation is a 501(c)(3) organization that fosters philanthropic support for Civica's work to manufacture and distribute affordable medications. The Foundation's first commitment is to support Civica's efforts to bring affordable insulin to all Americans. Leaders from nearly every corner of the diabetes ecosystem are partners in this initiative. Civica is leading a movement for patients, not profits. Because eliminating shortages and stabilizing high prices are in the best interest of patients. Join us. Learn more at **************** Job Description: The Manager, Regulatory Affairs will bring their knowledge and experience in service to patients and pursuit of excellence to secure and stabilize the supply of sterile generic injectable medications and provide affordable specialty medications to patients within the United States. The Manager, Regulatory Affairs will: Lead ANDA writing and review. Assist in developing and maintaining working templates for ANDA, including Mod 3-5. Assist in developing and maintaining standardized ANDA submission processes. Author specialized, preformatted, facility sections to create a facility core dossier (DMF) Support Labeling text operations across Civica, including CivicaRX and CivicaScript. Review Petersburg Facility projects/changes for product impacts and coordinate with RA team This role offers a flexible remote work style with travel to Civica's Petersburg, Virginia manufacturing facility and Lehi, Utah office as needed. Essential Duties and Responsibilities: Lead core dossier development and implementation Support the Regulatory and Research and Development ANDA team to create high quality submissions. Leads and represents Civica in regulatory meetings. Lead and administrate VEEVA regulatory information management (RIM) platform which uses end to end publishing Develop meaningful and collaborative relationships with internal/ external partners. Demonstrate success in influencing without positional authority within a highly matrixed organization. Basic Qualifications and Capabilities: We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue doing what is in the best interest of our patients. What we look for: A scientific degree with directly relevant professional experience in global regulatory affairs and regulatory operations of at least 7 years with a BA/BS Demonstrated organizational leadership skills Application of sound and accurate judgment to make timely decisions. Excellent strategic acumen, collaboration, and communication skills are required. Excellent interpersonal, verbal, and written communication skills. Proven success in: Direct support of the submission and approval of regulatory applications, amendments and changes including resolution of information requests Creating and implementing core systems and dossiers to assure efficiency in regulatory business operations Strategic thinking capability with business acumen to allow an understanding of how the parts impact the enterprise Building and maintaining complex collaborative relationships capable of influencing the delivery of aligned compliant solutions and decisions Physical Demands and Work Environment: Ability to travel in the U.S. and internationally, as needed, for contract manufacturing oversight and Civica manufacturing site located in Petersburg, VA. Travel of up to 20% may be required.

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.

At TCL North America, innovation powers every product we create-including our rapidly expanding HVAC solutions. As a global leader in consumer technology, we are growing our presence in the North American HVAC market with a focus on energy efficiency, smart connectivity, and exceptional performance. TCL fosters a dynamic and collaborative environment where team members can thrive, contribute meaningfully, and help shape the future of indoor comfort and climate control. Join us and be part of building the next generation of HVAC innovation. TCL is seeking a knowledgeable and detail-oriented Regulatory Compliance Manager to support our HVAC product portfolio. This role will be responsible for ensuring our products meet all relevant regulatory requirements and standards across energy, environmental, and labeling categories. You will work cross-functionally to align compliance activities with product strategy, guide internal procedures, and engage with regulatory bodies as needed. Responsibilities include, but are not limited to: Represent the company in key industry technical committees and working groups (e.g., AHAM, ASHRAE, AHRI, NEEP, HRAI) for window air conditioners, mini-split, unitary ducted to contribute to the development of safety, performance, and testing standards. Provide regulatory insights during due diligence processes, with expertise in state and local codes (e.g., CEC, ICC, IAPMO) and certification bodies (e.g., UL, CSA). Develop and implement a comprehensive product compliance framework, ensuring all products are accurately listed and maintained in regulatory databases (e.g., DOE CCMS, AHRI, NEEP). Coordinate with cross-functional teams to gather input and prepare accurate documentation before interfacing with regulatory agencies. Support the creation and rollout of internal policies and procedures to ensure consistent product compliance across the organization. Qualification/Requirements: Bachelor's degree in Business, Engineering, or Law. Minimum 3 years of experience in regulatory compliance within the HVAC industry, preferably with an HVAC manufacturer or technical/regulatory trade association. Advanced knowledge of HVAC systems, technology, components, and related standards. Familiarity with regulatory bodies and standards such as DOE, EPA, FTC, CEC, ICC, IAPMO, ASHRAE, AHRI, and others. Excellent verbal and written communications skills Creative & Innovative Thinking Organizational and management skills; ability to efficiently manage a variety of multiple concurrent projects simultaneously Strong analytical and problem-solving skills with high attention to detail. Excellent communication and organizational abilities. Proven ability to work independently and collaboratively in a fast-paced environment. Experience preparing regulatory filings and managing compliance projects. Benefits: Vacation: Starting at 5 days per year Health & Wellness Days: 10 days per year (prorated based on start date) Paid Holidays: 12 days per year Medical Insurance Dental Insurance Vision Insurance 401(k) Retirement Plan Pension Plan Paid Maternity Leave Job Type: Full-time Salary Range: $125,000 - $150,000 per year

Clorox is the place that's committed to growth - for our people and our brands. Guided by our purpose and values, and with people at the center of everything we do, we believe every one of us can make a positive impact on consumers, communities, and teammates. Join our team. #CloroxIsThePlace Your role at Clorox: The Director of Government Affairs will be responsible for providing strategic leadership and directional oversight of the enterprise-wide Government Affairs function for Clorox, a public consumer packaged goods company. In close collaboration with the Sustainability, Strategic Regulatory, and Legal teams, the successful individual will be responsible for building relationships with key stakeholders and shaping the regulatory landscape to advance the company's strategic business objectives. The Director of Government Affairs will play a critical role in developing and executing an enterprise advocacy strategy, including establishing a strong presence in Washington, D.C., managing relationships with key trade associations, overseeing political contributions, and tracking relevant legislation. The role will also focus on building influence in key federal districts and managing state and local issues related to the company's manufacturing facilities and offices. Reporting to the Vice President, Enterprise Risk Management and Government Affairs, this individual will be a dynamic leader with a passion for driving strategic influence, fostering a culture of collaboration, and effectively communicating opportunities and risks to internal and external stakeholders. In this role, you will: Lead the development and execution of a comprehensive government affairs strategy that establishes a strong presence in Washington, D.C., builds a reputation with Congress and the executive branch, and advances the company's strategic business objectives. Additionally, refine and help guide the External Affairs approach in international markets in which the Company operates. Develop and lead initiatives to connect executive stakeholders with relevant Members of Congress, fostering relationships and driving influence in key federal districts based on manufacturing locations and corporate interests. Work collaboratively with a team of government relations professionals, fostering a culture of accountability, collaboration, and continuous learning while ensuring alignment with functional and corporate business needs. Represent the company in external forums and engage with internal and external stakeholders, including trade associations, industry forums, and government officials, representing the Company's interests and commitment to responsible corporate citizenship. Manage relationships with enterprise trade associations, providing support and coordinating with key executive stakeholders. Oversee political contributions and ensure compliance with reporting requirements. Jointly develop the advocacy strategies with Business Units and the Strategic Regulatory team, aligning efforts to maximize impact. Track relevant pending legislation in close coordination with the Strategic Regulatory team, ensuring organization awareness of key issues and adjusting advocacy strategy as necessary. Develop and implement robust processes to manage state and local issues relative to manufacturing facilities and offices. Serve as a champion of government affairs, building relationships and effectively communicating enterprise-level priorities and risks to cross functional teams, ensuring government affairs considerations are integrated into business strategies and decision-making processes. Oversee and manage lobbying resources to ensure effective representation of the company's interests. What we look for: Bachelor's degree required, degree in political science, public policy, or related field. At least 8 years' experience in government affairs and legislative and regulatory processes at the federal and/or state level. Must also have experience in the CPG (consumer-packaged goods) industry with a strong network in Washington, D.C. Be able to effectively navigate complex political landscapes, drive organizational influence, and elevate the strategic importance of government affairs within the company. Have demonstrated experience in leading government affairs strategies, building relationships with key stakeholders, and managing political contributions. Must be a proven, effective communicator with the capability to advocate the company's interests and drive alignment across diverse audiences within the organization. Be able to set strategy, contributing to the creation and articulation of an inspiring vision for the organization's government affairs function and its broader impact on the enterprise. Have a collaborative and creative approach to developing advocacy strategies that support company strategies. The ability to set clear and challenging goals while committing the organization to improved influence and performance; tenacious and accountable in driving results. The ability to persevere in the face of challenges and exhibit a steadfast resolve to higher standards, effectively navigating ambiguity and complexity to solve critical issues impacting the business. Be able to attract and recruit top talent, motivate the team, delegate effectively, and manage performance. Encourage collaboration and visibly support the success of the team, creating a sense of purpose that engages others. Naturally connects and builds strong relationships with government officials, trade associations, and internal stakeholders, demonstrating high emotional intelligence and strong communication skills. Workplace type: Hybrid: This role will work onsite 3 days a week at a designated location in DC. The other two days will be remote. Our values-based culture connects to our purpose and empowers people to be their best, professionally and personally. We serve a diverse consumer base which is why we believe teams that reflect our consumers bring fresh perspectives, drive innovation, and help us stay attuned to the world around us. That's why we foster an inclusive culture where every person can feel respected, valued, and fully able to participate, and ultimately able to thrive. Learn more. [U.S.]Additional Information: At Clorox, we champion people to be well and thrive, starting with our own people. To help make this possible, we offer comprehensive, competitive benefits that prioritize all aspects of wellbeing and provide flexibility for our teammates' unique needs. This includes robust health plans, a market-leading 401(k) program with a company match, flexible time off benefits (including half-day summer Fridays depending on location), inclusive fertility/adoption benefits, and more. We are committed to fair and equitable pay and are transparent with current and future teammates about our full salary ranges. We use broad salary ranges that reflect the competitive market for similar jobs, provide sufficient opportunity for growth as you gain experience and expand responsibilities, while also allowing for differentiation based on performance. Based on the breadth of our ranges, most new hires will start at Clorox in the first half of the applicable range. Your starting pay will depend on job-related factors, including relevant skills, knowledge, experience and location. The applicable salary range for every role in the U.S. is based on your work location and is aligned to one of three zones according to the cost of labor in your area. -Zone A: $175,100 - $360,700 -Zone B: $160,500 - $330,700 -Zone C: $145,900 - $300,600 All ranges are subject to change in the future. Your recruiter can share more about the specific salary range for your location during the hiring process. This job is also eligible for participation in Clorox's incentive plans, subject to the terms of the applicable plan documents and policies. Please apply directly to our job postings and do not submit your resume to any person via text message. Clorox does not conduct text-based interviews and encourages you to be cautious of anyone posing as a Clorox recruiter via unsolicited texts during these uncertain times. To all recruitment agencies: Clorox (and its brand families) does not accept agency resumes. Please do not forward resumes to Clorox employees, including any members of our leadership team. Clorox is not responsible for any fees related to unsolicited resumes.

Business Unit: Global Regulatory Affairs Execution Team Employment Type: Contract Duration: 6+ months (with possible extensions) Rate: $46 - $50 /hr. W2. Posting Date: 6/27/2024. Notes: Only qualified candidates need apply. Fully remote. Approximately 30 hours per week. 3 Key Consulting is hiring! We are recruiting an Regulatory Writing Manager for a consulting engagement with our direct client, a leading global biotechnology company. Job Description: In this vital role you will prepare and coordinate the preparation of regulatory submission documents that comply with global regulatory standards. Day to day activities include: Write or lead all aspects of the writing of clinical study reports and Investigator Brochures for products in all phases of clinical development (phases 1-4) Write CTD sections including the Summary of Clinical Efficacy, Summary of Clinical Safety, Summary of Clinical Pharmacology, Summary of Biopharmaceutics, Clinical Overview, Table of All Studies, briefing documents, and safety narratives Write other regulatory submission documents (eg, RTQs, PIPs, white papers, breakthrough therapy applications, orphan drug applications) Lead study timelines for regulatory documents and regulatory submission strategy Act as a functional area representative and lead on product teams Assist with the following activities: hiring, resourcing therapeutic areas and project teams, and departmental governance Ensure quality of regulatory submission documents at all stages of development Provide expertise and mentorship on document design and principles of good medical writing to the department and product teams Participate in departmental meetings, as well as departmental and cross-departmental initiatives Top Must Have Skill Sets: Must have experience briefing documents with significant clinical content/Module 2 clinical summary documents. Looking for 3-5 years of experience with these document types. Masters or higher degree in biology, chemistry, or other scientific field 5+ years in writing clinical and regulatory documents Ability to optimally operate in an environment that involves negotiation, persuasion, collaboration, and analytical judgment Ability to analyze medical data and interpret its significance Sophisticated knowledge of scientific/technical writing and editing and of related regulatory guidance (eg, ICH) governing regulatory submission documents and industry compliance Basic Qualifications: Doctorate degree Or Master's degree and 3 years of Writing Regulatory or scientific submission/documents experience Or Bachelor's degree and 5 years of Writing Regulatory or scientific submission/documents experience Or Associate's degree and 10 years of Writing Regulatory or scientific submission/documents experience Or High school diploma / GED and 12 years of Writing Regulatory or scientific submission/documents experience Preferred Qualifications: Masters or higher degree in biology, chemistry, or other scientific field 5+ years in writing clinical and regulatory documents Ability to optimally operate in an environment that involves negotiation, persuasion, collaboration, and analytical judgment Ability to analyze medical data and interpret its significance Sophisticated knowledge of scientific/technical writing and editing and of related regulatory guidance (eg, ICH) governing regulatory submission documents and industry compliance Strong written/oral communication skills and attention to detail Understanding and application of principles, concepts, theories, and standards of scientific/technical field Strong time and project management skills, engaging approach, and perseverance with a drive for results Leadership skills and ability to guide and influence the work of others Strong leadership in a collaborative team environment Why is the Position Open? Supplement additional workload on team Interview Process: Phone screens and video conference We invite qualified candidates to send your resume to **************************. If you decide that you're not interested in pursuing this particular position, please feel free to take a look at the other positions on our website ******************************* You are also welcome to share this opportunity with anyone you think might be interested in applying for this role. Regards, 3KC Talent Acquisition Team

This position is responsible to acquire/maintain/audit company licensing and product registration as needed. 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. Implement systems and processes needed to ensure compliance with the receipt, storage and distribution of controlled substances, list 1 chemicals and other regulated products; as well as tracking distribution of prescription drugs and medical devices. Conduct periodic audits on facilities and customer site visits to assess levels of compliance and risk. Coordinate the implementation of systems and procedures to ensure compliance with OSHA regulations. Support Distribution Center management and designated staff on the actions necessary to maintain regulatory compliance. Provide support during government inspections and formulating the appropriate response and corrective actions. Provide guidance to the company and subsidiaries to perform actions in order to maintain regulatory compliance for various facilities. Provide support to Corporate Brand Development Group and other Business Units researching issues pertaining to regulatory matters. Secure and maintain proper company licensure and product registration as needed to supports HSI Operations and Business Units. Provide support in the coordination and conducting routine Regulatory audits of Henry Schein facilities, affiliates and subsidiaries. Develop appropriate awareness and training programs for TSMs consistent with regulatory compliance policies and procedures. Participate in special projects and performs other duties as required. SPECIFIC KNOWLEDGE & SKILLS: Understanding of regulations applicable to HS operations. GENERAL SKILLS & COMPETENCIES: General proficiency with tools, systems, and procedures Basic planning/organizational skills and techniques Basic analysis and problem solving skills Basic verbal and written communication skills MINIMUM WORK EXPERIENCE: Typically 1 to 3 years of related 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 $52,745-$72,525, 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.

Established in 1991, Collabera has been a leader in IT staffing for over 22 years and is one of the largest diversity IT staffing firms in the industry. As a half a billion dollar IT company, with more than 9,000 professionals across 30+ offices, Collabera offers comprehensive, cost-effective IT staffing & IT Services. We provide services to Fortune 500 and mid-size companies to meet their talent needs with high quality IT resources through Staff Augmentation, Global Talent Management, Value Added Services through CLASS (Competency Leveraged Advanced Staffing & Solutions) Permanent Placement Services and Vendor Management Programs. Collabera recognizes true potential of human capital and provides people the right opportunities for growth and professional excellence. Job Description Required: (Remote Opportunity - Temp to Perm) • The Regulatory Affairs Manager ensures compliance to FDA and other applicable regulations. • In this role, you will lead the preparation, analysis, and submissions dossiers to various governing agencies in supporting business growth. • The RA Manager supports compliance with applicable regulations including ISO, local, state, and/or federal requirements. • Preparing international regulatory submissions and FDA submissions which may include device 510(k), IDEs, PMAs) and serving as regulatory representative on selected project teams; developing departmental SOPs/policies regarding regulatory matters. Key responsibilities: • Lead Regulatory Associates or Specialists in addition to work as an individual contributor • Prepare, review and file FDA premarket submission to ensure devices are commercially available in the U.S.: pre-IDEs, IDEs, 510(k)s, PMAs and PMA Supplements. (Will also be involved in EU submissions) • Represent RA as core team member to drive innovation on Tech. Dev. Projects and follow through to market release. • Develop Regulatory Strategies for new or modified products and prepare project plans & budgets. • Monitor and provide management with impact of changes in the Regulatory environment. • Communicate with regulatory agencies on administrative and routine matters in addition to pre-clinical, pre-submission, and submission discussions under the direction of management. • Document, consolidate and maintain oral and written communication with FDA, notified bodies, and clinical investigators. • Support Design Control process. • Prepare Rational to file documentation for modifications to devices when appropriate. • Participate in FDA & other notified body Inspections. • Author and/or review regulatory procedures and update as necessary. • Review change control documents and ascertain Regulatory impact for external and internal documents. • Assist in development/maintenance of regulatory files, records and reporting systems of systematic retrieval of information. • Review promotional material and labeling for regulatory compliance. Qualifications Required qualifications:(Remote Opportunity) • Bachelor's degree required. Scientific or engineering field preferred. • 5+ years of medical device regulatory affairs experience. • Must have authored 510(k) submissions • Must have knowledge of U.S. FDA regulations and standards • 3+ years of experience interacting with FDA and/or other regulatory agencies • Experience with devices containing software is strongly preferred. • Must work well in team environments • Must demonstrate leadership skills in team setting. • Proven analytical abilities • Solid understanding of manufacturing and change control, and an awareness of regulatory trends Additional Information To know more on this position or to schedule an interview, please contact; Ujjwal Mane ************ ujjwal.mane[@]collabera.com

At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future. Discover Impactful Work: Provides operational leadership for the department, overseeing innovative solutions including regulatory expertise and client interface to provide strategic regulatory intelligence and guidance for product development from preclinical through registration and product optimization. Oversees projects and participates in strategic initiatives, acts as lead subject matter expert. Acts as liaison with internal and external clients in the provision and marketing of regulatory services. A day in the Life: • Manages staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, behavioral and technical coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime. Promotes all aspects of the company's Equal Employment Opportunity policy and Affirmative Action Plan. Assures department adherence to good ethical and regulatory standards. • Provides regulatory consulting and strategic advice to internal and external clients to determine the most appropriate regulatory and product development strategy for their products. Provides project specific strategy, technical expertise and coordination oversight for key clients' projects. Serves as the executive contact for key clients for all issues, including attendance at regulatory authority meetings and other public relations functions, which may be held face-to-face (F2F) or virtually. Ensures quality performance for key/managed projects. • Oversees project budgeting/forecasting to include creative input as to shifting of resources, allocations etc. to respond to a change in scope of personnel requirements to stay within project budget. Leads and participates in project meetings. • Ensures identification of out-of-scope activities in a contract in a timely manner and liaises with other departments to follow through on all aspects of contract modification. • Collaborates with business development and senior management in pricing and securing new business by making presentations to clients, developing and reviewing bid proposal texts and budgets and conducting contract negotiation through to closure with the client and BD. Actively engages in business development activities looking to attract collaborative and stand-alone projects. • Pursues existing clients who have a need for services to win more business. • Contributes to development and implementation of global/regional function/plans. • Ensures compliance with relevant organizational and department Standard Operating Procedures (SOPs) and Work Instructions (WIs). • Develops strategy and leads the development and implementation of processes and procedures to increase productivity and accuracy within the team. Keys to Success: Education and Experience: Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 12+ years). 5+ years of management responsibility Strong leadership skills In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills, Abilities -Mastery of English language, communication and negotiation skills, both oral and written, as well as local language where applicable. - Sharp attention to detail and quality with advanced editorial and proofreading skills. - Accomplished interpersonal skills to work effectively in a team environment and act as a liaison with other departments. -Advanced computer skills including the use of Microsoft Word, Excel, PowerPoint, Adobe Acrobat, and the capability to learn new technologies. -Excellent organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities, and handle multiple projects. -Professional negotiation skills. -Capable of working independently and exercising independent judgment to assess sponsor regulatory needs, propose innovative regulatory strategies, work with project team members to produce compliant deliverables, and ensure audit readiness. -Advanced understanding of global/regional/national requirements and regulatory affairs procedures for clinical trial authorization, licensing, and lifecycle management. -Expert knowledge of ICH and other global regulatory guidelines, with in-depth expertise in regulatory specialty areas such as preclinical, clinical, CMC, MDD, publishing, etc. -Advanced understanding of medical terminology, statistical concepts, and guidelines. -Sharp analytical, investigative, and problem-solving skills. -Advanced understanding of budgeting and forecasting, with the ability to interpret data. -Recognized executive presence with consultation and presentation skills. -Key representative of the company and clients at regulatory authority meetings and other public relation functions. -Effective critical and strategic thinking skills. -Capable of developing, supervising, evaluating, and mentoring departmental personnel, as well as delegating tasks and facilitating the completion of assignments. -Capable of contributing to global and regional functions implementation, resourcing, development, and expansion. -Capable of driving innovation in developing new ideas related to process improvements. -Excellent judgment, analytical, decision-making, and interpersonal skills to manage complex projects in parallel and manage rapidly changing priorities. -Capable of independently learning new technologies and providing strategies for tools/systems improvement to meet global regulatory requirements. -Capable of identifying and assessing risks and impacts to core functions. Physical Requirements / Work Environment Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role: Work is performed in an office environment with exposure to electrical office equipment. Occasional drives to site locations, frequent travels both domestic and international. Frequently stationary for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Moderate mobility required. Occasional crouching, stooping, bending and twisting of upper body and neck. Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. Ability to access and use a variety of computer software developed both in-house and off-the-shelf. Ability to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently interacts with others, relates sensitive information to diverse groups both internally & externally. Ability to apply abstract principles to solve complex conceptual issues. Requires multiple periods of intense concentration. Performs a wide range of complex tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task. Regular and consistent attendance.

BrainChild Bio is seeking a Director, Regulatory Affairs, to lead and execute the regulatory strategy for our CAR T programs. This role will serve as BrainChild Bio's primary regulatory representative, responsible for guiding regulatory activities across preclinical, clinical, and manufacturing stages, while partnering closely with internal teams and external partners.The Director will work cross-functionally with Clinical, CMC, Quality, and Patient Operations to plan and manage regulatory submissions, including INDs, IND amendments, and meeting packages. Responsibilities include developing regulatory strategies that support innovative CAR T development, preparing for and participating in FDA and ex-US health authority interactions, and ensuring documentation and filings are complete, accurate, and timely. The ideal candidate brings substantial experience in Regulatory Affairs within a clinical-stage biotech, strong working knowledge of FDA regulations for cell and gene therapy products, and the ability to operate both strategically and hands-on. We're seeking a collaborative, detail-oriented leader who thrives in a fast-moving environment and is motivated by bringing transformative therapies to patients.Responsibilities: Lead and execute regulatory strategies to support development of CAR T programs. Prepare, review, and submit INDs, amendments, and regulatory correspondence to FDA and other global health authorities. Serve as primary regulatory contact with health authorities, including FDA, EMA and other global agencies, representing BrainChild Bio in meetings and discussions. Collaborate cross-functionally with Clinical, CMC, Quality, and Patient Operations to ensure regulatory compliance and alignment with program objectives Identify risks and opportunities, providing strategic recommendations to accelerate development timelines. Advise on regulatory implications of protocols, manufacturing processes, and patient logistics. Manage regulatory timelines, submissions, and deliverables across multiple programs. Stay informed of emerging regulations, guidance documents, and industry trends specific to cell and gene therapy. Qualifications: 10+ years of regulatory affairs experience, including significant experience in cell and gene therapy, or advanced biologics. Strong working knowledge of FDA regulations and guidance for CAR T and other cell therapy products, as well as global regulatory frameworks. Demonstrated ability to develop strategic regulatory plans and execute them in a fast-paced clinical-stage biotech environment. Detail-oriented, proactive, and capable of balancing strategic leadership with hands-on execution. Exceptional communication skills for engaging regulatory authorities, senior leadership, and internal stakeholders. Skilled at identifying risks, solving complex regulatory challenges, and implementing proactive mitigation strategies.

The Director, Global Regulatory Affairs is responsible for contributing to the development and execution of regulatory strategies and managing regulatory submissions for Vistagen's products. This role involves collaborating with cross-functional teams to ensure compliance with global regulatory standards and efficient management of regulatory activities throughout the product lifecycle. This is a full-time position and may be performed remotely from any location within the continental U.S. The position will report to the Vice President, Global Regulatory Affairs. Key Duties & Responsibilities: Key responsibilities of this role include, but are not limited to: * Contribute to the regulatory strategy, development, and execution for Vistagen's products, including nonclinical and clinical regulatory strategy, INDs, marketing applications, and post-approval changes. * Collaborate with internal teams, such as R&D, Corporate Development, Quality Assurance, and Clinical, to ensure alignment of regulatory strategies with product development goals. * Identify regulatory risks and proactively work with cross-functional teams to develop mitigation strategies. * Perform critical review and provide strategic input on submission documents to ensure compliance with regulatory requirements, health authority guidance, and company policies. * Oversee the preparation, review, and submission of regulatory submissions to health authorities. * Coordinate, prepare, and contribute to the development of document packages for regulatory submissions, including INDs, NDAs, meeting requests, meeting briefing documents, responses to FDA comments and IRs, DSURs/Annual Reports, clinical study protocols, clinical study reports, and application amendments for assigned projects. * Lead regulatory project timelines, ensuring that deliverables are met in a timely and efficient manner, and resolve issues that may arise during the product lifecycle. * Act as a primary regulatory point of contact for IND(s) with the U.S. FDA. * Manage and mentor Regulatory Affairs direct report(s), providing guidance on regulatory issues, career development, and project management. * Stay up-to-date with evolving global regulations and industry trends, ensuring that the company remains compliant with current standards and best practices. Qualifications: * Bachelor's degree in Life Sciences, Pharmacy, or related field. Advanced degree (Master's, PhD, or PharmD) is preferred. * 8-10 years of experience in Regulatory Affairs. * Proven track record of successful regulatory submissions and approvals in relevant markets. * Management and mentoring experience preferred. * In-depth knowledge of regulatory requirements and guidelines (e.g. FDA, ICH). * Experience with electronic submission systems (e.g. eCTD, SPL). * Regulatory writing and liaison experience is required. * Excellent written and verbal communication skills, with the ability to present complex information clearly. * Strong problem-solving abilities and attention to detail. * Strong project management and organizational skills. * Ability to work under pressure and manage competing priorities. Compensation and Benefits What we offer: * Industry competitive compensation * Performance-based bonuses * Stock options * Employee Stock Purchase Plan * 401k plan * A collaborative and innovative work environment at the forefront of biotech advancements Give your best, live wholesomely: * Comprehensive healthcare coverage, including medical, dental, and vision plans for employees and dependents * FSA and HAS * Basic Life Insurance 2x Earnings and AD&D * Employee Assistance Program * Healthcare advocates group to help navigate the healthcare system Work-life balance: * Unlimited paid time off * Flexible work schedule * Remote work option * Paid holidays * Mental health days * Winter shutdown * Casual work environment We uphold the ethos of work-life harmony, where enjoyment is woven into our fundamental values of integrity, teamwork, compassion, and excellence. The anticipated salary range for candidates who will work remotely is $185,000-$215,000 per year. The final pay offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and years of experience within the job, the type of years and experience within the industry, education, etc. Provided they meet all eligibility requirements under the applicable plan documents, employees (and their eligible dependents) will be eligible to enroll in group healthcare plans that offer medical, dental, vision, and basic life insurance. Employees also will be able to enroll in our company's 401k plan provided they meet plan requirements. Employees will also enjoy paid holidays throughout the calendar year, subject to relevant terms outlined in the employee handbook. Eligibility requirements for these benefits will be controlled by applicable plan documents. Physical Demands: The physical demands described here are representative of those that must be met by an employee to perform the essential functions of this job successfully. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit. The employee is required to stand; walk; use hands to finger, handle, or feel and reach with hands and arms. The transition from standing and sitting often. Specific vision for this job includes close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus. This position requires the ability to lift and/or move up to 25 pounds occasionally. Evening and weekend work as necessary. Flexible hours (domestic time zones) may be required in this remote environment. DISCLAIMER Provided they meet all eligibility requirements under the applicable plan documents, employees (and their eligible dependents) will be eligible to enroll in group healthcare plans that offer medical, dental, vision, and basic life insurance. Employees also will be able to enroll in our company's 401k plan provided they meet plan requirements. Employees will also enjoy paid holidays throughout the calendar year, subject to relevant terms outlined in the employee handbook. Eligibility requirements for these benefits will be controlled by applicable plan documents. The above statements are intended to describe the general nature and level of work performed by employees assigned to this classification as well as general description of benefits and other compensation and it is not a substitute for applicable plan documents or company policies. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. EEO Employer: VISTAGEN THERAPEUTICS, INC., is an equal opportunity employer; all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected classification. All Employee's have rights under Federal Employment Laws and link to the three posters: Family and Medical Leave Act (FMLA) Poster Know Your Rights Poster; and Employee Polygraph Protection Act (EPPA) OVERVIEW OF THE COMPANY Headquartered in South San Francisco, CA, Vistagen Therapeutics, Inc. (NASDAQ: VTGN) is a late clinical-stage company leveraging its pioneering neuroscience and deep understanding of nose-to-brain neurocircuitry to develop and commercialize a broad and diverse pipeline of intranasal product candidates called pherines. Each pherine product candidate in Vistagen's neuroscience pipeline is designed to rapidly activate olfactory system and brain neurocircuitry to achieve desired therapeutic benefits and differentiated safety without requiring systemic absorption or binding to neurons in the brain. Vistagen's neuroscience pipeline also includes an oral prodrug, AV-101, with potential to impact certain neurological conditions involving the NMDA receptor. Vistagen is passionate about developing transformative treatment options to improve the lives of individuals underserved by the current standard of care for multiple highly prevalent disorders, including social anxiety disorder, major depressive disorder, and vasomotor symptoms (hot flashes) associated with menopause. Connect at *****************

MedCerts - a Stride Inc. company (NYSE: LRN) - is a national online training provider strengthening the workforce through innovative eLearning solutions. Focused on certifications in high-demand areas of allied healthcare and IT, it serves individuals from all backgrounds, including the military and their families, career changers and the under- and unemployed. MedCerts delivers career training through HD-quality video-based instruction, virtual simulations, games and animations, and on-the-job training through Experiential Learning solutions. Since 2009, the company has developed over 45 career programs, trained and up-skilled more than 35,000 individuals across the country and partnered with over 500 American Job Centers and more than 1,000 healthcare and academic organizations to build talent pipelines, and provide the option of articulated college credit to our students. In 2020, MedCerts was acquired by Stride, Inc. Stride has transformed the teaching and learning experience for millions of people by providing innovative, high-quality, tech-enabled education solutions, curriculum, and programs directly to students, schools, the military, and enterprises in primary, secondary, and post-secondary settings. For more information, visit medcerts.com. The Regulatory Affairs and Compliance Director will lead the pursuit, organization, maintenance, and archival activities related to State Authorizations and Eligible Training Provider List Authorizations. Primary responsibilities include but are not limited to the submission of new and renewal applications, processing documents as required by funder organizations, monitoring outcomes for compliance, project evaluation, analyzing data and submitting reports. GENERAL DUTIES AND RESPONSIBILITIES Review and complete Master Agreements, contract, and applications for State Higher Education Boards, Workforce Investment Boards, and other regulatory entities. Completing ETPL applications for new state and regional sales territories Proactively inform leadership and sales leaders on all aspects of regulatory affairs for current statuses and future road mapping. Review and provide interpretation of proposal requirement Gather information regarding education laws, ordinances, and regulation Adding new program offerings or modifying program offerings on already approved state and regional ETPL approvals Assist all stakeholders with compliance reporting deadlines, licensing, authorization, and accreditation applications as needed Conduct research on various government agencies and identify new funding opportunities Other duties and special projects as assigned REQUIRED QUALIFICATIONS Direct, robust, and successful experience in regulatory affairs/compliance environments Bachelor's Degree is required, Master's degree is preferred Excellent oral and written communication Must have experience leading a team Work effectively in a fast-paced changing environment Ability to work under pressure and meet deadlines, while maintaining a positive attitude Ability to work independently and to carry out assignments to completion with limited guidance WORKING CONDITIONS This is a remote position in which work will be completed during normal business hours (approximately 8:30am - 5:00pm). COMPENSATION & BENEFITS: Stride, Inc. considers a person's education, experience, and qualifications, as well as the position's work location, expected quality and quantity of work, required travel (if any), external market and internal value when determining a new employee's salary level. Salaries will differ based on these factors, the position's level and expected contribution, and the employee's benefits elections. Offers will typically be in the bottom half of the range. We anticipate the salary range to be $68,598.80 - $138,674.53. Eligible employees may receive a bonus. This salary is not guaranteed, as an individual's compensation can vary based on several factors. These factors include, but are not limited to, geographic location, experience, training, education, and local market conditions. Stride offers a robust benefits package for eligible employees that can include health benefits, retirement contributions, and paid time off. Job Type Regular The above job is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor. All employment is “at-will” as governed by the law of the state where the employee works. It is further understood that the “at-will” nature of employment is one aspect of employment that cannot be changed except in writing and signed by an authorized officer. If you are a job seeker with a disability and require a reasonable accommodation to apply for one of our jobs, you can request the appropriate accommodation by contacting *********************. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities Stride, Inc. is an equal opportunity employer. Applicants receive consideration for employment based on merit without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status, or any other basis prohibited by federal, state, or local law. Stride, Inc. complies with all legally required affirmative action obligations. Applicants will not be discriminated against because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at **************** . This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply. **Purpose and Scope:** We are seeking an experienced CMC Regulatory Affairs Director with deep expertise in the United States regulatory frameworks and global CMC strategy. This role will lead the development and execution of innovative regulatory strategies for small molecule products (primarily) and biologics or other new modalities (secondary) across all phases of development and commercialization. The ideal candidate will be a recognized thought leader who can influence regulatory policy, drive strategic initiatives, and represent the company in key external forums. This position plays a key global leadership role in the Regulatory Affairs department for the Chemistry, Manufacturing and Controls (CMC) aspects of regulatory documents and submissions. Responsible for multiple regulatory activities in collaboration with local and global stakeholders (e.g., Product Development & Manufacturing, Regulatory Affairs, Quality Assurance, Business Partners). Responsible for developing regional/global CMC regulatory strategy (e.g., CMC strategy/planning for new products), driving CMC submission related activities and successfully executing regional/global regulatory strategies in collaboration with local and global stakeholders. Responsible for supporting business critical interactions inside and outside of Astellas Regulatory Affairs on complex CMC issues and questions in collaboration with local and global stakeholders. Leads and/or coaches a team or individual team member of regulatory CMC professionals. The ideal candidate brings deep expertise in designing and executing innovative, accelerated CMC regulatory strategies across oncology and rare disease portfolios. This includes demonstrated experience navigating global expedited pathways such as FDA Breakthrough Therapy, PRIME, Project Orbis, and other rapid-review designations. The candidate will lead the development and implementation of forward-leaning CMC approaches that enable faster patient access while ensuring robust quality, compliance, and lifecycle readiness. Success in this role requires strong strategic acumen, cross-functional leadership, and a proven ability to partner with health authorities to shape regulatory solutions that support program acceleration and long-term product sustainability. **Responsibilities and Accountabilities:** **Strategic Leadership:** + Define and implement global CMC regulatory strategies with a strong focus on North American requirements. + Provide expert guidance on US FDA regulations, while also ensuring compliance and proactive risk management across major markets including Japan, China, and EU. **Policy & Advocacy:** + Represent the company in industry associations, ICH working groups, and industry forums to influence regulatory policy and harmonization efforts. + Monitor evolving regulatory landscapes in the US and other global countries, translating changes into actionable strategies for internal teams. **Cross-Functional Collaboration:** + Partner with Product Development & Manufacturing, Quality Assurance and Regulatory Affairs teams to ensure alignment on CMC strategies. + Serve as a scientific and regulatory resource for complex technical issues, enabling science and risk-based solutions. **External Engagement:** + Build and maintain strong relationships with FDA, PhRMA, ICH, other regulatory authorities and industry collaborations. + Lead advocacy initiatives for innovative technologies and precedent-setting projects. **Operational Excellence:** + Oversee preparation and review of CMC sections for regulatory submissions (IND, NDA, BLA, post-approval changes). + Ensure consistency and quality in dossier preparation across regions. **Expected Key Accountabilities from Global Regulatory Aspects** + Acts as CMC regulatory expert and is accountable for recommending global CMC regulatory strategy. Works closely with other individuals/groups within Astellas global Regulatory Affairs and with regional and global stakeholders to ensure consistency and to identify options for risk discussions. + Member of global teams/task forces which require expert interpretation of applicable EMA/FDA/ICH/Global regulations to ensure CMC compliance within the organization. Sets direction for key operations and new initiatives in collaboration with regional and global stakeholders. + Provides CMC regulatory expertise for New Product Planning and Licensing including during due diligence activities. + Provides oversight on the preparation and review of complex global registration packages to ensure effective data presentation and quality scientific data against applicable regulatory requirements. In collaboration with regional and global stakeholders, determines the best way to present information in assigned regulatory submissions to maximize reviewability by global health authorities. Defines and implements regulatory strategies and priorities for; global registrations, supplemental submissions/variations, response documents to health authority questions including Agency meeting planning and preparation, and global change control issues in collaboration with local and global stakeholders. + Reviews global regulatory submissions for consistency and quality across regions including detailed input on eCTD Module 3 documents for clinical trial and marketing authorization registration filings and DMFs. + Actively seeks out knowledge of overall corporate/global strategy and other general factors that affect the regulatory positions taken within the company, and with global health authorities, and incorporates this knowledge in interactions with others. Will also impact global strategy directly by participating in strategic planning in therapeutic area and with global stakeholders for chemistry, manufacturing and controls aspects. + Provides regulatory guidance for compendial issues (Ph.Eur., USP and JP etc.) and monograph preparation. + Provides support to the CMC RA Modality Head to develop an environment to enable CMC RA professionals to optimally operate in the matrix environment of RA, R&D, Product Development & Manufacturing within Astellas. + Leads and/or coach a small team or individual team member of (regulatory) CMC professionals, provides training. + Interacts with executive level on routine and serious matters; internally and externally to influence policy and strategy; with development partners; with global health authorities at review, management and senior staff, including negotiations on controversial areas. Established rapport with global health authorities that enables constructive exploratory discussions. + Facilitator role in health authority meetings. Works on complex and diverse problems with decision making that has functional or corporate impact. Actions may have serious implications for operations, revenue, and/or credibility. **Required** + Advanced degree in Chemistry, Engineering or equivalent degree (PhD, PharmD, MS preferred). + 10+ years of direct experience in CMC Regulatory Affairs within the pharmaceutical or biotech industry, with significant exposure to North American regulatory requirements. + Proven track record in developing and implementing global CMC strategies and influencing regulatory policy. + Strong knowledge of FDA, ICH and global guidelines; prior experience in ICH initiatives highly desirable. + Expert technical and regulatory knowledge of the requirements for compliance with GMPs, GLPs, GCPs and an in-depth knowledge of global regulatory CMC submission requirements, with a strong understanding of the application of ICH and other guidance. + Exceptional communication and leadership skills; ability to influence internal and external stakeholders. + Experience representing companies in trade associations and industry forums. + Experience with global regulatory aspects of CMC across multiple dosage forms involving undefined frameworks with technical complexity and broad scope. + Experience with process development, analytical characterization, process scale-up and/or regulatory registration of drug substances or drug products (including oral and parenteral + dosage forms) is required. + Demonstrated track record for successful interactions with global health authorities related to CMC submissions. + Ability to navigate a global organization and to act globally and regionally as appropriate. + Excellent interpersonal, verbal and written communication skills with a demonstrated ability to resolve conflict situations and influence regulatory authorities, as well as internal and external stakeholders in high impact situations. + Proven leadership skills is preferred. **Salary Range** $170,450 - $267,850 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations) **Benefits:** + Medical, Dental and Vision Insurance + Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down + 401(k) match and annual company contribution + Company paid life insurance + Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions + Long Term Incentive Plan for eligible positions + Company fleet vehicle for eligible positions + Referral bonus program \#LI-SS Category Regulatory CMC Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

About the Company Adagene Inc. (Nasdaq: ADAG) is a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based cancer immunotherapies. Adagene combines computational biology and artificial intelligence to design novel antibodies that address unmet patient needs. Powered by its proprietary DPL platform, composed of NEObody, SAFEbody, and POWERbody technologies, Adagene's highly differentiated pipeline features novel immunotherapy programs. Adagene has forged strategic collaborations with reputable global partners that leverage its technology in multiple approaches at the vanguard of science. Job Summary The Head of Global Regulatory Affairs is a key leadership position that will oversee and is accountable for global regulatory, quality strategies and policies for Adagene. This individual will be responsible for regulatory leadership and oversight to help develop global regulatory and quality compliance strategies, and guidance. As a Head of Global Regulatory Affairs this person will perform a critical role in strategies, documentations, submissions, and company interactions to regulatory authorities such as FDA, CFDA, and other regulatory agencies. This individual must leverage their extensive experience to represent Adagene in regulatory affairs in discussions with internal and external stakeholders. This role will provide global regulatory expertise and contribute to the delivery of the Clinical, R&D and Operations strategies. This individual will lead cross-functional and multicultural team and diverse environment. The candidate must have an entrepreneurial mindset, highly motivated and purpose driven leader who is able to flexibly and effectively lead and interact with multi-disciplinary teams. This individual should have experience in championing new ideas in a dynamic, international, and innovative environment. The successful candidate will have a track record of accomplishments in global regulatory affairs, project management, strong collaboration, and communication skills. This position may require travelling to our company headquarters in Suzhou, China. Essential Functions Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Serve as a key member of senior management team to provide leadership and guidance to ensure business objectives are aligned with company strategies and achieve operational objectives to gain product approvals. Provide counseling, training, and interpretation of FDA, CDE and other regulatory requirements to all company personnel. Lead, coach, and mentor the Regulatory departments and ensuring appropriate levels of accountability for decision making and clearly communicate cross-functionally within the organization. Oversee preparation and filing of all regulatory documents with the FDA, CDE and other regulatory agencies. Develop and maintain external relationships with key opinion leaders and regulatory officials. Direct the development of systems, practices, and processes to ensure effective ongoing review of clinical development plan, product design and/or manufacturing changes and adverse events. Provide leadership and direction for significant deviation events that may impact compliance status or represent the significant business risk. Responsible for company's product quality and reliability to meet or exceed regulatory. Lead company's Quality Compliance to ensure compliance with regulatory agencies and all applicable standards. Develop and execute quality design and quality assurance strategy for new product development and sustaining business activities. Support the quality system, provide effective leadership support, training, and guidance to all company personnel. Serve as the ambassador to and develop strategies for responses to regulatory related inquiries from global regulatory agencies and ensure issues are addressed in a timely manner. Responsible for leading all regulatory activities for assigned projects in line with regulatory requirements, regional requirements and scientific and company policies and procedures. Provide regulatory oversight and strategic and technical guidance in discussions with teams in support of due diligence for potential in-licensing activities, external collaborations, and acquisitions. Lead Global Regulatory efforts for all INDs, NDAs, and life cycle management. Maintain knowledge of highly complex regulatory requirements up to current date, while influencing preparation of new regulatory guidance wherever possible. Champion initiatives that contribute to global process improvements, which have a significant impact on business. Direct activities of Contract Manufacturing Organizations (CMOs) and Contract Research Organization's (CRO's), material suppliers, consultants, and vendors. Other projects or responsibilities as may be required. Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions of the job. Minimum Qualifications - Education and Experience A PharmD or PhD degree in a scientific discipline and a minimum of 10 years of pharmaceutical and drug development regulatory experience, as well as a background in dealing with the FDA and international regulatory agencies is required for this position. Minimum 10-15 years of progressively responsible Regulatory experience in a pharmaceutical, biotechnology or related environment. Position also requires a minimum of 5-8 years of leadership experience in a global regulatory affairs role. Must have extensive knowledge of regulatory requirements, including ICH GCP, GMP, GLP, and regional requirements and understand current global and regional trends in regulatory affairs and the ability to assess the impact of these requirements to the business. Extensive knowledge of clinical development, FDA and international global clinical trial regulations and ICH GCP GMP, CLP guidelines and relevant requirements Substantial experience in all aspects of regulatory affairs, including Clinical, Commercial support, CMC, with a track record of successful submissions and license approvals with CDER and CBER Demonstrated global leadership capability, ideally gained through regulatory leadership of multiple global development programs and NDA/MAA submissions. Excellent working knowledge of the US, European and Asian regulations for drugs and biologics. Knowledge of global regulatory guidance as they relate to the overall global regulatory strategy. Must be able to travel (US/international) up to 25%. Preferred Qualifications - Education and Experience RAC Certification preferred Equal Opportunity Employer Adagene is an equal opportunity employer that is committed to diversity and inclusion. We prohibit discrimination and harassment of any kind based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability, pregnancy, veteran status, or other legally protected characteristics as outlined by federal, state, or local laws. Learn more about your EEO Rights as an applicant. Adagene will not discriminate or retaliate against applicants who inquire about, disclose, or discuss their compensation. Adagene will consider for employment all qualified applicants with criminal histories in a manner consistent with applicable law. If you are applying for a position in San Francisco, review the San Francisco Fair Chance Ordinance guidelines applicable in your area. Adagene participates in the E-Verify program in certain locations as required by law. Learn more about the E-Verify program. Adagene is committed to working with and providing reasonable accommodation to applicants with physical and mental disabilities. Adagene is a drug-free workplace.

Primary Duties & Responsibilities At Globe Life, we are committed to empowering our employees with the support and opportunities they need to succeed at every stage of their career. Our thriving and dynamic community offers ample room for professional development, increased earning potential, and a secure work environment. We take pride in fostering a caring and innovative culture that enables us to collectively grow and overcome challenges in a connected, collaborative, and mutually respectful environment that calls us to help Make Tomorrow Better. Role Overview: Could you be our next Manager, Regulatory Compliance? Globe Life is looking for a Manager, Regulatory Compliance to join the team! In this role, you will be responsible for managing the compliance team. The Manager ensures that project and department milestones and goals are met while adhering to approved budgets. They are also responsible for leadership and team development, ensuring staff are educated on all current DOJ standards and trained to adapt to the evolving regulatory environment. This is a remote / work-from-home position. What You Will Do: * Train the team on the value and implementation of the compliance framework and practices for risk assessment and policy development. * Monitor both progress and performance of senior and junior compliance analysts to formulate any needed recommendations for improvements. * Track team velocity progression and provide leadership insights. * Prepare and present compliance program analysis for inclusion in Senior Level reporting. * Organize, lead, and direct cross-functional meetings that advise and facilitate the navigation of extenuating circumstances and business complexities. * Develop and execute enterprise-wide compliance strategies with support from the Senior Director of Regulatory Compliance. * Manage (internal) regulatory relationships and interactions. * Provide guidance on complex compliance matters to the team and stakeholders. * Mentor and coach junior compliance team members. * Implement changes to compliance processes due to new or amended regulations. * Utilize established internal controls and auditing systems to identify, detect, and correct noncompliance. * Prepare and update communication materials. * Assist with training initiatives that educate stakeholders about compliance requirements. * Assess current projects for complexity and highest priority, managing multiple when necessary. What You Can Bring: * Bachelor's degree in business, finance, or related field. * 7+ years of experience in the compliance field, preferably within the life insurance industry. * 3+ years of experience as a people leader or in an SME/mentoring role. * Advanced Compliance Certifications preferred (CCEP, ISO 37301, FLMI, AIRC, ACAMS, etc.). * Extensive knowledge of regulatory frameworks, industry trends, and best practices. * Proven leadership and project management skills. * Strong people leading and development skills. * Strong interpersonal and stakeholder influencing skills. * Excellent communication and collaboration skills. * Ability to present information with confidence and clarity for Senior Management and Board-level reporting. * Utilize strong observation, analytical, and problem-solving skills. * Commercially savvy with the ability to exercise discretion with respect to highly confidential/sensitive information. * Ability to exhibit integrity, ethical standards, and sound judgment. Applicable To All Employees of Globe Life Family of Companies: * Reliable and predictable attendance of your assigned shift. * Ability to work full-time and/or part-time based on the position specifications. How Globe Life Will Support You: Looking to continue your career in an environment that values your contribution and invests in your growth? We've curated a benefits package that helps to ensure that you don't just work, but thrive at Globe Life: * Competitive compensation designed to reflect your expertise and contribution. * Comprehensive health, dental, and vision insurance plans because your well-being is fundamental to your performance. * Robust life insurance benefits and retirement plans, including a company-matched 401 (k) and pension plan. * Paid holidays and time off to support a healthy work-life balance. * Parental leave to help our employees welcome their new additions. * Subsidized all-in-one subscriptions to support your fitness, mindfulness, nutrition, and sleep goals. * Company-paid counseling for assistance with mental health, stress management, and work-life balance. * Continued education reimbursement eligibility and company-paid FLMI and ICA courses to grow your career. * Discounted Texas Rangers tickets for a proud visit to Globe Life Field. Opportunity awaits! Invest in your professional legacy, realize your path, and see the direct impact you can make in a workplace that celebrates and harnesses your unique talents and perspectives to their fullest potential. At Globe Life, your voice matters. Location: 7677 Henneman Way, McKinney, Texas

The Operations Regulatory Specialist II provides analytical support and leadership for key internal Operations projects and partners with the Operations departments to ensure all regulatory and compliance deliverables are met. This is a hybrid position and will work in the Dayton HQ office every Tuesday and Thursday. Essential Functions: Represent operations on cross-functional project work teams Submit, monitor and prioritize IT tickets for the operations departments Review special projects and identify issue trends and potential resolutions Assist with reporting and processes that are regulatory related and tied to state issues deadlines Assist with the development, drafting and review of P&P's and job aides for Operations Assist in educating/training Business Partners on operations functions. Research and resolve provider claim issues and escalations by analyzing system configuration, payment policy, and claims data when requested by Compliance Perform analysis of all claims data to provide decision support to Claims management team in relation to regulatory requests Identify and quantify data issues within Claims and assist in the development of plans to resolve data issues Partner and collaborate with Operations Business Owners to ensure all audit and regulatory deliverables are met accurately and on time. These deliverables may include: Documentation gathering - i.e. review of Standard Operating Procedure and/or Policy and Procedure to the audit/inquiry requirements Audit Universe monitoring and/or creation - collaboration with IT and the Business Owners to validate the accuracy of the data and formatting of the final report for submission Prepare Operations Business Owners for live questions and answers with the state regulators or auditors Track and assist with remediation efforts for Corrective Action Plans related to all audit findings Ensure the timeliness submission of the Regulatory Reporting required by the state and federal agencies for Operations Track all Compliance required training on a yearly and new hire basis for Operations Assist with all readiness activities in relation to implementation of a new line of business for Operations Perform any other job-related instructions, as requested Education and Experience: Bachelor's degree or equivalent years of relevant work experience required Minimum of two (2) years of healthcare operations environment is required Regulatory and/or compliance experience is preferred Competencies, Knowledge and Skills: Advanced level experience in Microsoft Word, Excel and PowerPoint Data analysis and trending skills Demonstrated understanding of claims operations specifically related to managed care Advanced knowledge of coding and billing processes, including CPT, ICD-9, ICD-10 and HCPCS coding Ability to work independently and within a team environment Attention to detail Familiarity of the healthcare field Critical listening and thinking skills Negotiation skills/experience Strong interpersonal skills Proper grammar usage Technical writing skills Time management skills Strong communication skills, both written and verbal Customer service orientation Decision making/problem solving skills Licensure and Certification: None Working Conditions: General office environment; may be required to sit or stand for extended periods of time Compensation Range: $61,500.00 - $98,400.00 CareSource takes into consideration a combination of a candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required for the role, and other external and internal data when establishing a salary level. In addition to base compensation, you may qualify for a bonus tied to company and individual performance. We are highly invested in every employee's total well-being and offer a substantial and comprehensive total rewards package. Compensation Type (hourly/salary): Salary Organization Level Competencies Create an Inclusive Environment Cultivate Partnerships Develop Self and Others Drive Execution Influence Others Pursue Personal Excellence Understand the Business This is not all inclusive. CareSource reserves the right to amend this job description at any time. CareSource is an Equal Opportunity Employer. We are dedicated to fostering an inclusive environment that welcomes and supports individuals of all backgrounds.#LI-SD1

EQT is one of the United States' leading producers of natural gas and the first traditional energy company of scale in the world to achieve Net Zero on a Scope 1 and Scope 2 basis. From the office to the field, the #EQTeam is fueling the future. Power your potential with us. At EQT, we are making strides toward becoming the best producer by creating long-term value for all stakeholders, including employees, landowners, communities, industry partners and investors. Our vision is to evolve EQT into a modern, connected, digitally enabled organization. With an incredibly collaborative culture and a determined, progressive workplace, EQT was both named a National Top Workplace, as well as one of Pittsburgh's Best Places to Work! Join our Qrew! The Compliance Lead, Regulatory Compliance supports EQT's enterprise compliance framework by leading execution of key regulatory compliance activities throughout the organization. This role coordinates regulatory tracking, impact assessment, and change management efforts, ensuring that new or evolving requirements are efficiently assessed, communicated, and integrated into business operations. Working cross-functionally with Legal, Operations, Upstream, Midstream, Environmental, and Safety teams, this position helps drive consistency, strengthen controls, and reinforce a culture of proactive compliance across the organization. The Compliance Lead, Regulatory Compliance responsibilities include but are not limited to: Maintain EQT's regulatory repository and compliance control documentation to ensure requirements remain current, traceable, and actionable. Track and assess regulatory developments affecting upstream and midstream operations, as well as the domestic and international supply of natural gas to customers. Lead the regulatory impact assessment process, coordinating input from business stakeholders to evaluate applicability and operational impact. Partner with compliance champions and process owners to embed regulatory obligations into procedures, training, and monitoring activities. Support the development and execution of remediation and control improvement plans for identified compliance risks or findings. Analyze preventable notices of violation (NOVs) and similar enforcement actions to identify root causes and drive sustainable corrective actions. Coordinate compliance change management activities, ensuring updates to requirements are communicated, documented, and operationalized. Provide data-driven insights to inform compliance reporting, audits, and management reviews. Contribute to continuous improvement initiatives by identifying efficiency opportunities in compliance monitoring, documentation, and reporting. Required Experience and Skills: Bachelor's degree in law, engineering, environmental science, business, or a related discipline. 7-10 years of progressive regulatory compliance experience in the natural gas, midstream, or broader energy sector. Proven ability to interpret, implement, and operationalize requirements from agencies such as FERC, PHMSA, EPA, OSHA, and state-level regulators. Experience maintaining compliance repositories, impact assessments, or control frameworks. Strong analytical and problem-solving skills, with the ability to assess regulatory risk and drive remediation activities. Excellent communication and collaboration skills; able to influence and coordinate across diverse teams and functional areas. Demonstrated integrity, judgment, and discretion when managing sensitive or confidential information. Skilled in managing multiple priorities and adapting to a dynamic regulatory environment. Proficiency with GRC platforms, data analytics, or regulatory tracking systems preferred. Preferred Experience and Skills: Advanced degree (JD, MBA, or master's) or professional certification (CCEP, CRCM, CPCU, CAMS). Experience supporting or enhancing compliance management systems and regulatory reporting tools. Strong understanding of regulatory frameworks and enforcement practices relevant to the natural gas industry. Prior experience coordinating compliance change management or regulatory implementation projects. Effective at developing presentations and reports for business and regulatory audiences. Ability to mentor junior compliance staff or serve as a subject matter resource within the compliance program. Remote work is being considered for this role excluding the following states: California, Connecticut, Delaware, Illinois, Indiana, Louisiana, Massachusetts, Michigan, New Jersey, New York, and Tennessee unless willing to relocate. Selected incumbent will be placed into the position that best suits their abilities and experience level. EQT Corporation and its subsidiaries is an Equal Opportunity Employer -- Disabilities/Veterans.