About the role The Manager, Regulatory Affairs will support the development and execution of regulatory strategies for assigned programs, with a balanced focus on CMC and Clinical Regulatory Affairs. This role will serve as a key regulatory contributor on cross-functional project teams and support interactions with U.S. and global health authorities under the direction of senior regulatory leadership. The position emphasizes hands-on regulatory execution, document preparation, and cross-functional coordination across clinical development and CMC activities from IND through early commercialization. Location: Remote Essential Functions - Regulatory Strategy Support - - Contribute to regulatory strategy development for assigned programs under the guidance of senior regulatory leadership. - Identify and communicate regulatory considerations, risks, and mitigation strategies related to CMC and Clinical activities in a phase-appropriate manner. - Support global regulatory planning across development stages (IND through post-approval). - Regulatory Submissions & Documentation - - Draft, review, and coordinate regulatory documents for submissions including INDs, IND amendments, annual reports, briefing documents, IBs, and responses to health authority requests. - Support the preparation of clinical and CMC sections of regulatory submissions ensuring accuracy, clarity, and compliance with applicable regulations (FDA, EMA, ICH). - Ensure regulatory documents meet quality, formatting, and submission readiness standards. - CMC & Clinical Regulatory Support - - Provide regulatory input to CMC teams related to manufacturing changes, comparability, specifications, and lifecycle management. - Review clinical documents including protocols, ICFs, CSRs, DSURs, and study plans to ensure regulatory compliance. - Support alignment between clinical development plans and CMC readiness. - Cross-Functional Collaboration - - Act as a regulatory representative on project teams, working closely with Clinical Development, CMC, Quality, Nonclinical, and Regulatory Operations. - Coordinate regulatory activities and timelines to support development milestones. - Prepare internal regulatory updates and contribute to team presentations as needed - Health Authority Interaction Support - - Support preparation for health authority meetings, including briefing packages and Q&A documents. - Participate in agency communications as appropriate, under the direction of senior regulatory leadership. - Compliance & Quality - - Ensure compliance and regulatory obligations are handled in accordance with SOPs and applicable regulations. - Maintain up-to-date knowledge of regulatory guidelines and industry trends relevant to CMC and clinical development. Qualifications - Bachelor’s degree in a scientific or related discipline. - Five (5) years of regulatory affairs experience in pharmaceutical or biotechnology development. - Demonstrated experience supporting IND-stage and/or clinical development programs. - Experience drafting regulatory documents and supporting regulatory submissions - Working knowledge of CMC and clinical regulatory requirements. - Familiarity with eCTD structure and regulatory documentation standards Please note that CG Oncology does not accept unsolicited information and/or resumes from search firms or agencies for our job postings. Any resumes or client information submitted to our careers page or any employee of CG Oncology by any search firm or agency without an applicable contract in place will become the property of CG Oncology and no fee(s) will be paid. Total Rewards CG Oncology offers very competitive and comprehensive Total Rewards, helping to support and reward our global team of high-performing employees focused on developing bladder-saving therapeutics for patients afflicted with bladder cancer. - HIGHLY COMPETITIVE SALARIES - ANNUAL PERFORMANCE/MERIT REVIEWS - ANNUAL PERFORMANCE BONUSES - EQUITY - SPECIAL RECOGNITION Well-Being Benefits In addition to our Total Rewards, CG Oncology offers a variety of Well-Being Benefits to meet the majority of the needs of our unique and growing workforce. These benefits are designed to support our team to achieve a healthy balance between work and their personal lives to remain refreshed, engaged, and creating an environment where each person can find a deeper meaning and purpose in their work. Well-Being Benefits eligibility begins the 1st of the month after hire. While a majority of these benefits are for our US-based workforce, we continue to assess comparable levels of benefits for our international team members that are aligned with country-specific regulations and their national programs offered. - FULLY REMOTE WORK ENVIRONMENT - REST AND RECHARGE BENEFITS - Unlimited Flexible Time Off - HOLIDAYS –In 2025 we will observe 14 holidays - RETIREMENT – 401K with 100% company Safe Harbor match up to 4% of base salary - HEALTH (MEDICAL, DENTAL, VISION) – PPO & HDHP – Cigna/Principal - HEALTH SPENDING ACCOUNTS - HSA (with Annual Company Contribution), FSA, FSA-DC - ILLNESS & DISABILITY PROTECTION – Company Paid LTD Coverage + Voluntary Plans - LIFE INSURANCE – Company Paid 1 x base salary + Voluntary Plans - ADDITIONAL EXCLUSIVE BENEFITS – Voluntary Legal, Pet, Plus More CG Oncology is an Equal Opportunity Employer: All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. At CG Oncology, we are building a community of intelligent and passionate team members that share our Vision, Mission and Values, and while the biotechnology space can feel limited in BIPOC, non-binary and even female representation, we endeavor to make hiring decisions that will continue to grow and support our team in the direction of maintaining cultural diversity and sustainability.

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description This role involves reviewing and editing content for accuracy and adherence to style guidelines. - Review and edit content for correct spelling, grammar, and sentence structure - Ensure fulfillment of creative brief and adherence to AMA and client style - Maintain editorial integrity from outline to printer’s proof - Fact check materials and align with writers on annotating and referencing - Represent Editorial at internal start-up and status meetings - Facilitate project completion with the extended team - Ensure alignment with each client’s MLR submission process Qualifications - Bachelor’s degree in English, Journalism, or similar field - 3+ years of editing experience in healthcare and/or pharmaceutical industry required - At least 1 year of experience in the advertising and/or pharmaceutical marketing industry preferred - Editorial experience in the pharmaceutical/medical communication or ad agency field - Thorough knowledge of AMA (11th edition) style - Proficiency with Microsoft Office suite of products - Familiarity with editing in Adobe Acrobat Professional Requirements - Industry experience in advertising, pharmaceutical marketing, medical communications, and/or medical education - Familiarity with Veeva, Zinc, or MLR reviews and submissions systems - Knowledge of FDA requirements with respect to pharmaceutical advertising Benefits - Discretionary annual bonus - Health insurance - Retirement savings benefits - Life insurance and disability benefits - Parental leave - Paid time off for sick leave and vacation

Impact Advisors, LLC is a nationally recognized healthcare management consulting firm delivering Best in KLAS advisory, implementation, and optimization services. We are driven by a commitment to exceed client expectations and are proud to be a trusted partner to many of the nation's leading healthcare organizations. Our mission to drive patient-centered, value-driven outcomes has earned us prestigious industry accolades. To learn more about us, visit www.impact-advisors.com As a Strategy & Operations Managing Consultant you continue to grow your healthcare career in a collaborative, supportive and inclusive environment. You’ll be a vital leader on a team that is passionate about improving healthcare. As the Health Plan Operations Managing Consultant you must possess deep healthcare expertise in the health plan domain. In this role, you will work closely with healthcare clients to optimize and support their claims processing operations by configuring, analyzing, and troubleshooting Epic Tapestry, FACETS and other core operating systems, ensuring seamless integration across downstream workflows, maintaining data integrity, and driving process improvements that enhance accuracy, efficiency, and overall system performance. You will have ownership of all deliverables within an engagement and serve as the primary day-to-day contact with clients. Leadership and the ability to be a player/coach are critical characteristics of being successful in this role. You’ll be supporting and leading initiative teams in driving improvements for our clients. As a manager, you’ll be an example of our strong company culture and have a hand in developing our innovative and quickly expanding team. About Impact Advisors: Impact Advisors is a nationally recognized healthcare consulting firm dedicated to improving healthcare through process improvement and technology. As a trusted healthcare leader, we help clients optimize clinical and operational performance through our Best in KLAS® advisory and implementation services. Our goal is to provide innovative solutions to the industry’s toughest challenges. About You: · Must have a broad understanding of the three market segments including Individual/Family (Retail), Commercial and Government sponsored (Medicare & Medicaid) · Must have broad understanding of key business functions within a health plan including network configuration, claims adjudication, benefit design and an awareness of ancillary products specifically how they interact with the core product. · Experienced consultant leader focused on developing strategies to solve complex operational problems for our healthcare clients · 3–5 years of experience working with Epic Tapestry and/or FACETS in a healthcare payer or provider environment. · Strong understanding of claims processing workflows, including adjudication, pricing, and downstream system integration. · Proven experience in technical analysis, system configuration, and troubleshooting of claims or related healthcare applications. · Proven experience developing business requirements liaising with technical architects and developers to facilitate planning and implementation processes · Familiarity with data integration tools, SQL queries, and interface troubleshooting to support claim data flow and issue resolution. · Structuring engagement activities, delegating effectively, and coaching junior staff. Serve as the final reviewer for deliverables with a thoughtful, diligent, and critical eye. Lead client calls regularly, delegating speaking parts as appropriate. · Strategy development experience is strongly preferred. · Able to manage competing priorities with a high level of organization and attention to detail · Have a growth mindset and are prepared to expand and develop your talents with this rapidly growing team · Hold a Bachelor’s degree · An advanced degree is preferred but not required (MBA, MHA, MPH). · Able to travel according to client needs up to 80% of the time · Authorized to work in the US Our People and Culture: We believe in a caring, fun, honest and autonomous work environment and we recognize that our dedication to our associates drives our success. Our mission to create a Positive Impact fuels our associates to innovate and deliver high value services to our clients. At Impact Advisors, we prioritize transparency and equity in our compensation practices. This role has a salary range of $130,000 to $ 170,000 and may also be eligible for an annual discretionary bonus. This range accounts for various factors, including skills, experience, training, certifications, and organizational needs For salaried positions, this role may also be eligible for an annual performance bonus. Additional benefits and perks may also be available, depending on the position and employment terms. This range reflects consideration of several factors, including skills, experience, training, certifications, and organizational needs. Our People and Culture At Impact Advisors, we cultivate a caring, fun, honest, and autonomous work environment. Our success stems from our associates' dedication and a shared mission to create a “Positive Impact.” We embrace diversity and inclusion, fostering an environment where all employees feel valued and empowered. Join Impact Advisors and make a real difference in healthcare.

Alternate Locations: Work from Home; Greensboro, NC (North Carolina) Work Arrangement: Remote : Work at home employee residing outside of a commutable distance to an office location. Relocation assistance: is not available for this opportunity. Requisition #: 74707 The Role at a Glance We are excited to bring on a Regulatory GAAP and Statutory Investment Reporting Analyst to support the Investment Accounting and Reporting Team. The Investment Accounting and Reporting team is a highly visible and dynamic team, where you will gain experience in a wide array of areas including financial reporting, investment accounting, financial analysis, amongst other valuable skills. The team consists of both hybrid and remote employees. This opportunity will provide a work from home/remote work environment. Background Details As a Regulatory GAAP and Statutory Investment Reporting Analyst, you will be responsible for providing timely and accurate investment reporting for the General Account Invested Assets on a Statutory, GAAP (specifically SEC reporting), Management and Tax basis and assisting with performing and documenting SOX investment controls. You will be responsible for performing investments research, analysis and ad hoc internal reporting of Lincoln’s investment positions to support strategic investment operations and initiatives. Additionally, this role will also lead team projects related to investment strategic initiatives, team process improvements/efficiencies, and investment reporting system enhancements and developments. You will build relationships and work closely with various business areas and key stakeholders to achieves operational, system and project objectives. If this sounds like a role for you, please read on! What you'll be doing - You will provide timely and proper investment reporting of General Account Invested Assets under applicable Statutory, GAAP, Management and Tax basis. You will specifically be responsible for the investment disclosures for LFG’s SEC reporting (10K and 10Q Investment related footnotes and disclosures) and Statutory reporting (including blue book and green book schedules, footnotes, general interrogatories, supplemental interrogatories etc.). - You will serve as a project manager for investment accounting and reporting related team projects. - You will provide ad hoc accounting research and information on fixed income and other investments for existing and developing investment strategies to various internal business areas. - You will support an effective function for your assigned area by identifying risks, researching technical investment accounting issues, and gathering all necessary information. You will communicate identified risks and financial implications to management. You will assist with performing and documenting certain SOX investment controls. - You will resolve discrepancies and take actions on matters and inquiries on the General Account Invested Assets from portfolio management and multiple asset managers. - You will collaborate effectively with team members and applicable key stakeholders across the enterprise to facilitate the accurate and timely completion of the investment accounting process. - You will remain current in professional and industry trends and make a positive contribution by making suggestions for improvement, and learning new skills, processes and procedures. - You will maintain knowledge on current and emerging developments/trends for assigned area(s) of responsibility, assesses the impact, and collaborates with management to incorporate new trends and developments in current and future solutions. What we’re looking for Must have experience (Required): - 4 Year/Bachelor's degree or equivalent work experience (4 years of experience in lieu of Bachelor's) - 5+ Years of experience in investment accounting and reporting or financial reporting that directly aligns with the specific responsibilities for this position. - Technical knowledge in investment accounting and reporting, including prior experience working in investment accounting systems. - Strong problem-solving and critical thinking skills, identifying the appropriate resources and tools to drive solutions. - Excellent organizational skills with the ability to prioritize workload and multi-task while maintaining strict attention to detail. - Ability to lead and manage team projects through successful completion. - Strong relationship management skills with internal clients (e.g. management, peers and colleagues) and external parties (auditors, regulators, asset managers, reinsurers, other external partners); proven ability to develop collaborative approaches. - Ability to identify and recommend process improvements. - Successfully completes regulatory and job training requirements. - Proficiency with Microsoft Office Suite (Excel, Word, PowerPoint, Outlook). Nice to have experience (Preferred): - Prior external audit experience in the insurance industry strongly desired. Application Deadline Applications for this position will be accepted through April 30, 2026, subject to earlier closure due to applicant volume. What’s it like to work here? At Lincoln Financial, we love what we do. We make meaningful contributions each and every day to empower our customers to take charge of their lives. Working alongside dedicated and talented colleagues, we build fulfilling careers and stronger communities through a company that values our unique perspectives, insights and contributions and invests in programs that empower each of us to take charge of our own future. What’s in it for you: - Clearly defined career tracks and job levels, along with associated behaviors for each of Lincoln's core values and leadership attributes - Leadership development and virtual training opportunities - PTO/parental leave - Competitive 401K and employee benefits - Free financial counseling, health coaching and employee assistance program - Tuition assistance program - Work arrangements that work for you - Effective productivity/technology tools and training The pay range for this position is $69,000 - $124,600 with anticipated pay for new hires between the minimum and midpoint of the range and could vary above and below the listed range as permitted by applicable law. Pay is based on non-discriminatory factors including but not limited to work experience, education, location, licensure requirements, proficiency and qualifications required for the role. The base pay is just one component of Lincoln’s total rewards package for employees. In addition, the role may be eligible for the Annual Incentive Program, which is discretionary and based on the performance of the company, business unit and individual. Other rewards may include long-term incentives, sales incentives and Lincoln’s standard benefits package. About The Company Lincoln Financial (NYSE: LNC) helps people to confidently plan for their version of a successful future. We focus on identifying a clear path to financial security, with products including annuities, life insurance, group protection, and retirement plan services. With our 120-year track record of expertise and integrity, millions of customers trust our solutions and service to help put their goals in reach. Lincoln Financial Distributors, a broker-dealer, is the wholesale distribution organization of Lincoln Financial. Lincoln Financial is the marketing name for Lincoln Financial Corporation and its affiliates including The Lincoln National Life Insurance Company, Fort Wayne, IN, and Lincoln Life & Annuity Company of New York, Syracuse, NY. Lincoln Financial affiliates, their distributors, and their respective employees, representatives and/or insurance agents do not provide tax, accounting or legal advice. Lincoln is committed to creating an inclusive environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Follow us on Facebook, X, LinkedIn, Instagram, and YouTube. For the latest company news, visit our newsroom. Be Aware of Fraudulent Recruiting Activities If you are interested in a career at Lincoln, we encourage you to review our current openings and apply on our website. Lincoln values the privacy and security of every applicant and urges all applicants to diligently protect their sensitive personal information from scams targeting job seekers. These scams can take many forms including fake employment applications, bogus interviews and falsified offer letters. Lincoln will not ask applicants to provide their social security numbers, date of birth, bank account information or other sensitive information in job applications. Additionally, our recruiters do not communicate with applicants through free e-mail accounts (Gmail, Yahoo, Hotmail) or conduct interviews utilizing video chat rooms. We will never ask applicants to provide payment during the hiring process or extend an offer without conducting a phone, live video or in-person interview. Please contact Lincoln's fraud team at fraudhotline@lfg.com if you encounter a recruiter or see a job opportunity that seems suspicious. Additional Information This position may be subject to Lincoln’s Political Contribution Policy. An offer of employment may be contingent upon disclosing to Lincoln the details of certain political contributions. Lincoln may decline to extend an offer or terminate employment for this role if it determines political contributions made could have an adverse impact on Lincoln’s current or future business interests, misrepresentations were made, or for failure to fully disclose applicable political contributions and or fundraising activities. Any unsolicited resumes or candidate profiles submitted through our web site or to personal e-mail accounts of employees of Lincoln Financial are considered property of Lincoln Financial and are not subject to payment of agency fees. Lincoln Financial ("Lincoln" or "the Company") is an Equal Opportunity employer and, as such, is committed in policy and practice to recruit, hire, compensate, train and promote, in all job classifications, without regard to race, color, religion, sex, age, national origin or disability. Opportunities throughout Lincoln are available to employees and applicants are evaluated on the basis of job qualifications. If you are a person with a disability that impedes your ability to express your interest for a position through our online application process, or require TTY/TDD assistance, contact us by calling 260-455-2558. This Employer Participates in E-Verify. See the E-Verify notices. Este Empleador Participa en E-Verify. Ver el E-Verify avisos.