Director, Regulatory Remote Cabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases. The CABA™ platform encompasses two complementary strategies which aim to advance the discovery and development of engineered T cell therapies with the potential to become deep and durable, perhaps curative, treatments for a broad range of autoimmune diseases. The lead CARTA (Chimeric Antigen Receptor T cells for Autoimmunity) strategy is prioritizing the development of rese-cel, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy. Rese-cel is currently being evaluated in the RESET™ (REstoring SElf-Tolerance) clinical development program spanning multiple therapeutic areas, including rheumatology, neurology and dermatology. Cabaletta Bio’s headquarters and labs are located in Philadelphia, PA. For more information, please visit www.cabalettabio.com and connect with us on LinkedIn. Uniquely Differentiated. Rapid. Elegant. At Cabaletta, we are driven by the shared mission of developing cures, where a patient’s own cells are used to fight disease. We are building a culture grounded in the knowledge that successful cures can be achieved for patients if every member of the Cabaletta is focused on the success of the team. To nurture this, we make an active commitment to the well-being and continuous growth of each employee who joins the team. In this way, we are not only working to improve the lives of patients, but of everyone involved. #CabalettaCrew. We’re proud to be a Great Place to Work-Certified™ company! #GPTWcertified Check out what our employees say makes working here so great: Working at Cabaletta Bio Inc | Great Place to Work® Position Description: This role can be remote or based out of our Philadelphia, PA headquarters. We are seeking an experienced and highly motivated professional to join our team as a Director, Regulatory. This role will serve as the Regulatory Lead for our pivotal program leading to BLA. In this role, you will be responsible for developing and executing regulatory strategies to support the development and commercialization of our cell therapy products. You will work closely with cross-functional teams, regulatory agencies, and external partners to ensure compliance with regulatory requirements and successful product registration. If you are a passionate and experienced regulatory affairs professional with a strong knowledge of BLA requirements, we encourage you to apply for this position that will play a crucial role in advancing innovative cell therapies to benefit patients worldwide. Key Responsibilities: - Regulatory Strategy Development: - Manage all regulatory aspects of Cabaletta’s lead program through pivotal clinical studies and BLA/MAA approval, including the preparation of clinical trial applications, amendments, correspondence, applications for expedited programs, health authority meetings, marketing applications, and labeling and promotional reviews for regulatory agencies, including FDA, Health Canada, EMA, MHRA and other countries, as applicable. - Collaborate with cross-functional teams including clinical and nonclinical development, manufacturing, quality assurance, and medical affairs to develop and implement competitive regulatory strategies that expedite development and maximize the probability of success for cell therapy product development. - Stay informed about evolving regulations and guidelines related to cell therapy and adapt strategies accordingly. - Assess and communicate potential regulatory risks and propose mitigation plans. - Regulatory Submissions and Compliance: - Prepare and oversee the submission of regulatory documents, including INDs, CTAs, BLAs/MAAs, and other relevant submissions to regulatory agencies (e.g., FDA, EMA). - Ensure the quality and accuracy of regulatory submissions, adhering to timelines and requirements. - Ensure compliance of programs and submission documentation with current regulations and guidelines governing cell therapy products. - Regulatory Interactions: - Represent the company during interactions with regulatory agencies, including meetings, teleconferences, and written communication. - Prepare meeting requests, briefing documents, and coordinate and prepare teams for meetings with health authorities - Coordinate and prepare responses to requests for information from regulatory agencies - Build and maintain positive relationships with regulatory authorities to facilitate successful regulatory approvals. Qualifications: - Bachelor's degree in life sciences or related field required (advanced degree preferred). - Minimum of 8 years of experience in regulatory affairs for biopharmaceuticals or cell therapy (preferred). - Strong understanding of the drug development process from pre-clinical to commercialization, (prior BLA experience required). - Experience in reviewing and writing regulatory submission documents for global regulatory filings such as IND, CTAs, and BLAs/MAAs and related health authority interactions. - Knowledge of GXPs and key requirements for clinical, nonclinical and CMC documentation for regulatory submissions in ICH regions. - Excellent communication, negotiation, and leadership skills - Strong team orientation and passion for continuous self-development Our name – Cabaletta – is derived from the operatic term that represents a rapid, repetitive, and technically challenging section of an operatic aria, designed to showcase the skills of the lead singer. Analogously, Cabaletta Bio strives to achieve rapid and repetitive product development, building on our indication prioritization and biologic platform that targets the driver of specific autoimmune diseases without the need for long-term immunosuppression. For more information, please visit https://www.cabalettabio.com/join-our-crew Our most important asset is our people, and we offer competitive benefits, PTO, and stock option plans. Cabaletta Bio is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law. Cabaletta Bio, Inc. does not accept unsolicited resumes from recruiters, employment agencies, or staffing firms. To conduct business with Cabaletta, a Master Services Agreement (MSA) must be executed and confirmed prior to submitting any information relating to a potential candidate. Without a signed MSA, Cabaletta shall not be responsible to any individual or entity for any payment relating to any form of fee or compensation. And, if a resume or candidate is submitted by a recruiter, an employment agency, or a staffing firm without a fully executed MSA, Cabaletta has the unrestricted right to pursue and hire any of those candidate(s) without any legal or financial responsibility to the recruiter, agency, and/or firm. #LI-REMOTE

Department: Project Development Team Reports To: Co-Executive Director Location: Remote (Preference for Northeast or Mid-Atlantic) Company Description At Working Power, our mission is to advance a clean energy economy that builds wealth and power for people in historically underinvested communities while delivering affordable, reliable energy, creating local jobs, and reducing harmful pollution. We partner with community organizations, affordable housing providers, small businesses, and labor organizations to co-develop, finance, and enable community-level ownership of clean energy projects. With a focus on deep community benefits, we support our partners to bring projects from concept through completion. Summary/Objective Are you an energetic project development leader with experience in community-based clean energy? Are you passionate about delivering positive results in service of community partners and climate solutions? Do you have a passion for managing and mentoring high performing teams? If so, you may be an ideal candidate for Director of Project Development. We are looking for a leader who will work closely with our Executive team to help refine Working Power’s strategy, and who will lead our development team in project execution and delivery. Responsibilities will include: - Oversee a 3-5 person team through both long-term planning and day-to-day development of distributed generation projects, from conception through to construction. - In partnership with the Executive Team and other colleagues, build out sustainable and mission-driven pathways to further growth and community impact. - Standardize and professionalize WP’s project development processes. Essential Functions - Provide leadership, coordination and guidance to a team of project developers. - Oversee our project pipeline, schedules, and budgets. - Collaborate with the Executive, Asset Management, and Finance teams to ensure program/project visibility and alignment. - Identify opportunities to apply, adapt or expand WP’s business model to suit local energy and policy conditions, and community needs. - Develop and manage trust-based relationships with community organizations that lead to mutually beneficial partnerships and projects. - Manage and prioritize across our portfolio of projects and deadlines to optimize deployment and investment. - Oversee the selection and management of third-party service providers (engineering, legal, environmental, etc.) - Represent WP and highlight our impact, partnerships, and opportunities at conferences, stakeholder events, and with the media. - Travel to project sites, team meetings and related events on average 20% of the time. Qualifications Experience, Skills and Competencies: - A minimum of 8 years of combined experience in the fields of community partnership, distributed clean energy project development and community finance, with a track record of increasing responsibility. - A minimum of 3 years of experience leading and managing successful teams and developing department strategies. - Demonstrated success in supporting community-led, clean energy development, rooted in strong working relationships across community, funder, technical and public sector stakeholders and partners. - Excellent written and verbal communication skills with the ability to translate technical and financial information clearly and succinctly. - Deep commitment to equity and experience working in a cross-functional, collaborative environment with diverse teams in a virtual environment. - Embraces teamwork as a core leadership value, fosters collaboration across teams with humility and shared purpose, and builds strong working relationships across community, funder, technical and public sector stakeholders and partners. - Demonstrated ability to move fluidly from strategy to implementation and operations, using data to drive decision making, learning, and continuous improvement in dynamic, shifting environments. - Master's degree in Business, Public Policy, Urban Development, or a related field, or equivalent experience. Compensation Depending on the candidate's experience level, the annual base salary will be between $150,000 - $180,000 Benefits include: an inclusive and flexible work culture, paid time off, comprehensive health, dental and vision benefits, and 401(k) with a 4% match. To Apply Please submit your resume and cover letter. In your cover letter please describe: - What about Working Power’s mission is exciting to you and aligned with your experience? - What makes you an excellent team leader? - How has your experience prepared you for this role? Applications will be accepted on a rolling basis until the position is filled. We encourage you to apply at your earliest convenience. Don’t meet every single requirement? Studies show that women, people of color, and folks who identify as non-binary are less likely to apply to jobs unless they meet every qualification. Working Power is dedicated to building a diverse, inclusive, and authentic workplace. If you're excited about this role, and your experience doesn’t align perfectly with every qualification in the job description, we encourage you to apply anyway. You may be just the right candidate for this or other roles. Working Power is an equal-opportunity employer. We are deeply committed to equitable hiring and diversity in our staffing as a fundamental value in our work. We do not discriminate in employment opportunities or practices based on actual or perceived race, color, religion, national origin, sex (including pregnancy, childbirth, or related conditions), age, marital status, sexual orientation, gender identity or expression, veteran status, uniform service member status, disability or any other characteristic protected by law. Women, people of color, bilingual and bicultural individuals, LGBTQIA+ persons, and people with disabilities are encouraged to apply.

Director / Senior Director, Regulatory Affairs (Clinical & CMC) Department: Regulatory Work Location: Remote (US based). TCG Labs Soleil's headquarters is located in South San Francisco, CA, but we are open to remote work for this role. Position Summary: The Director/Senior Director, Regulatory Affairs will lead and execute global regulatory strategy and operations to enable the development of our therapeutics. This individual will oversee both Clinical and CMC regulatory functions, providing strategic and operational leadership across IND/CTA submissions, clinical development programs, and CMC activities. The ideal candidate will bring deep experience in protein and antibody therapeutics and hands-on expertise in early-stage biotech environments. Key Responsibilities: - Lead the development and implementation of global regulatory strategies for both clinical development and CMC to support company objectives and timelines. - Serve as the regulatory lead on project teams, providing expert guidance on regulatory requirements, risks, and opportunities across the development phases. - Partner closely with Clinical, Nonclinical, CMC, and Quality teams to align regulatory activities with development goals. - Advise executive leadership on regulatory matters, timelines, and risk mitigation strategies. - Lead preparation, submission, and management of global regulatory submissions (INDs, CTAs, amendments, safety reports, briefing packages). - Lead the preparation, submission and management of briefing documents for agency interactions - Represent the company in global regulatory agency interactions including INTERACT, pre-IND, End-of-Phase, and Scientific Advice meetings. - Provide regulatory input into clinical development plans, protocols, and study reports and collaborate with clinical operations to enable the clinical study. - Collaborate with the CMC team for developing strategy and review CMC sections of regulatory submissions (Module 3) ensuring alignment with evolving global requirements. - Collaborate with manufacturing and quality functions to ensure compliance with regulatory expectations for GMP and biologics manufacturing. Qualifications: - Advanced degree (PhD, PharmD, or MS preferred) in a scientific discipline relevant to biologics development. - 10+ years of regulatory affairs experience, with significant leadership responsibilities in CMC and clinical regulatory functions. - Proven track record of regulatory leadership in the development of antibody-based therapeutics, ideally from pre-IND through to late Phase 2 stage development. - Hands-on experience with IND, CTA, and global health authority interactions and writing regulatory documents - Strong working knowledge of regulatory requirements and guidelines (ICH, FDA, EMA) for both clinical and CMC biologics development. - Experience in early-stage company; comfortable with fast paced environment and building processes fit for purpose. - Excellent written, verbal, and interpersonal communication skills; proven ability to influence cross-functional teams and senior leadership. Preferred Attributes: - Experience with immune-oncology, autoimmune and metabolic therapeutic areas. - Ability to work in a fast-paced environment and ability to manage multiple product regulatory IND/CTA filings at the same time. Company Overview TCG Labs-Soleil, established in partnership with The Column Group, a science-focused venture capital firm, is pioneering a novel ‘venture capital-biotech’ model. Our core mission is to efficiently translate scientific insights into therapeutic solutions for patients facing serious diseases. This model supports scientific entrepreneurs from the initial idea to clinical proof of concept (PoC) by combining a dedicated fund (TCG Labs) with our independent, evergreen R&D center led by a top-tier scientific team (Soleil). Together, we create an integrated ecosystem that fosters the development of single-asset portfolio companies, strategically poised for transacting after clinical PoC. For more details, visit TCGLSoleil.com and follow us on LinkedIn EEO Statement TCG Labs-Soleil is an Equal Opportunity Employer. We do not discriminate against qualified applicants based upon any protected group status, including but not limited to race, religion, color, creed, sex (including breastfeeding and related conditions), gender identity/gender expression, pregnancy (including childbirth and related conditions), national origin, ancestry, age, marital status, military or veteran status, sexual orientation, genetic information, physical or mental disability or medical condition as defined by applicable equal opportunity laws. Any request for accommodation can be directed to contact@tcglsoleil.com. Benefits and Compensation TCG Labs-Soleil provides a competitive benefits package that includes access to Medical, Dental, and Vision Insurance, Life Insurance, Short and Long Term Disability, Health Savings Account (HSA), Flexible Spending Accounts (FSA), 401k plan and PTO. The anticipated salary range for fully qualified candidates applying for this role will be $200,000 - $270,000 annually (not including discretionary bonus, equity, and benefits). The final salary offered will be dependent on several factors that include but are not limited to relevant previous experience including duration and type of experience within the industry, education, and internal equity. Staffing Agencies TCG Labs-Soleil does not accept unsolicited agency resumes and will not pay fees to any third-party agency or firm that doesn’t have a signed agreement with TCG Labs-Soleil. Please do not send agency CVs/resumes through TCG Labs-Soleil website or TCG Labs-Soleil Employees. Inquiries must be sent to contact@tcglsoleil.com with the Subject Heading: Staffing Agency Request.

Who We Are ProgressNow is a nationwide network of 28 State Partner Affiliates that run year-round strategic campaigns to promote progressive ideas and values and win elections. Each affiliate is a communications, digital outreach, and media hub of full-time professionals who work with partner organizations to engage and mobilize diverse communities and activists through cutting-edge digital communications and innovative earned- and paid-media strategies. A core part of the in-state and national progressive infrastructure, our state affiliates reach and move millions of voters through data-driven best practices, and organic and paid digital content built on decades of experience and research. What You’ll Do: - Develop and manage a message and content testing plan to support affiliates and the ProgressNow network’s organic content distribution, relying primarily on Grow Progress’s rapid test tool - Create and distribute messaging guidance and talking points for ProgressNow affiliate staff based on available testing and research - Attend message and research briefings and ensure ProgressNow national and affiliate staff are up to date on new findings - Maintain a current database of messaging one-pagers - Provide technical assistance and support to state affiliates on research needs - Promote and share research findings from ProgressNow affiliates across our network and to partners - Translate research into creative direction—shaping the look, tone, and feel of content alongside designers and content producers - Work closely with your team to turn research-backed and tested messaging guidance into visual and video content that resonates with target audiences - Manage the messaging and research team, including content creators and designers Who You Are & Keys to Success (the must-haves) To be successful in this job, you will excel in these areas: - Strategist’s mind: You quickly grasp the subtleties of complex issues and identify patterns in challenges. You generate insightful, pragmatic, equitable, and sustainable solutions to tackle common challenges and produce positive change. You have a successful track record of taking a concept from idea to implementation. - Creative and adaptive: You bring fresh ideas, are thoughtful about how to engage audiences, and are able to work across teams to turn insights into meaningful ideas and approaches. - Excellent communication skills: You have a strong mastery and proven track record in communications strategy. You produce clear, compelling, and concise written communications and are able to do so quickly in rapid response situations. You have excellent verbal communication skills, present knowledge clearly and succinctly, and provide context while asking questions to understand others’ perspectives. - Entrepreneurial and resourceful: You overcome challenges and leverage resources to creatively solve problems. You propose solutions to issues without much guidance (but aren’t afraid to ask questions). You proactively ask for help, anticipate problems, and course-correct where needed. You operate with a team-first mentality to ensure projects reach goals without ego. - Inclusive leadership and management: You inspire, motivate, and support others to take action and meet goals. You delegate skillfully. You hold the team accountable and acknowledge growing edges (in self and others) while helping others grow. You use coaching, training, and feedback to develop others and support problem-solving. - Relationship builder: You bring enthusiasm for meeting and engaging with people, especially our national and affiliate staff. You empathize with the communities and partners we serve. You’re able to put people at ease, especially when there are lines of difference. You listen closely to understand needs or concerns and take steps based on that input. You get back to people promptly. You take pride in providing clear, helpful information. - Commitment to racial equity and social justice: You recognize the role of race, income, age, immigration status, and other identities in shaping societal disparities, and you consistently amplify community voices to advocate for more equitable policy solutions. You recognize how your own identities show up in the work, and welcome, reflect on, and act on feedback with an eye toward continuous learning about race, ability, and other lines of difference. Experience managing survey and message research is a plus, but not a requirement. Experience managing people is a prerequisite for the position. If you were here right now, you would be: - Working with the content creator to develop and run a rapid message test that implements and furthers your overall message testing and development plan. - Meeting with a state affiliate to review their research plans & needs and provide technical assistance. - Attending a national messaging webinar and writing a talking points summary for state affiliates. What Else You Should Know ProgressNow is an equal opportunity employer, and we value having staff who come from communities that are most impacted by our issues. We especially encourage people of color, LGBTQ people, gender non-conforming people, and people with disabilities to apply. The position is full-time and fully remote. The role requires 15% travel. Expected travel includes one annual staff retreat and two ProgressNow conferences. Compensation Because negotiating is inherently inequitable, we want to be transparent about what benefits we can offer up front and avoid negotiation. The starting salary for this position is $110,000. Our benefits include: - Unlimited vacation with a requirement that each staff member take at least 2 weeks each year. - Eight paid holidays as well as an office closure annually between Christmas and New Year’s Day. - Employer-paid health, vision, and dental insurance - A 401K plan with 3% employer match - Annual professional development stipend