Title: Sr. Manager, Regulatory Affairs - CMC & Reg. Sciences Location: Chicago United States Job Description: Full-time Description About Us: Founded in 2017 and based in Chicago, Meitheal is focused on the development and commercialization of generic injectable medications and, as of 2022, has expanded its focus to include fertility, biologic, and branded products. Meitheal currently markets over 60 U.S. Food and Drug Administration (FDA)-approved products across numerous therapeutic areas including anti-infectives, oncolytics, intensive care, and fertility. As of January 2025, Meitheal, directly or through its partners, has 19 products in the research and development phase, 22 additional products planned for launch in 2025, and 24 products under review by the FDA. Meitheal's mission is to provide easy access to fairly priced products through robust manufacturing, consistent supply, and rapid response to our customers' needs. Ranked #2 in 2024 on Crain's Fast 50 in Chicago, and in the top 100 of Crain's Best Places to Work in Chicago from 2022 to 2024, Meitheal emulates the traditional Irish guiding principle we are named for - working together toward a common goal, for the greater good. The estimated salary range for this position is $120,000 to $155,000. The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. What We Offer - Competitive pay and medical, dental, and vision insurance - Flexible spending accounts - Long- and short-term disability insurance, as well as life insurance - 401(k) plan with employer contribution - Competitive PTO and company-paid holidays - Paid parental leave (maternity & paternity) - Onsite gym - Hybrid work schedule Position Summary: The Senior Manager, Regulatory Affairs - CMC & Regulatory Sciences will be responsible for providing regulatory guidance to product development, supporting, and reviewing CMC sessions in submissions & deficiency responses, aiming for efficient and robust product development and high-quality regulatory submissions of biosimilars. S/he will work closely with the management team of Regulatory department to develop regulatory strategies for projects and portfolios, contributing to the transformation and growth of regulatory team to meet the needs of company's business growth of biopharmaceuticals. Essential Duties and Responsibilities; other duties may be assigned. - Contribute to regulatory strategy in new projects and our portfolio. - Provide regulatory guidance and advice to partners in development, technology transfer, and manufacturing. - Manage the regulatory aspects of products and projects, including achievement of timelines and deliverables to align with corporate and departmental goals. - Prepare and review communication documents & submissions to the agencies, including IND, BIA, BPD2/4, BLAs, etc. - Work and address complex and technical issues with solid scientific rationalization. - Identify and act on issues and risks from a regulatory perspective. - Provide due diligence and review documents from domestic and international partners for technical and regulatory compliance. - Provide regulatory assessments to the company (internal and partners), including change controls and/or document changes based on ICH and FDA guidelines. - Represent the regulatory function on cross-functional developmental teams primarily with Operation, Quality, Legal and Marketing groups. - Track and interpret FDA new guidance & new requirements and assess their impact on product development, including expertise required, timeline, and budgeting. - Support business development efforts. - Track deficiency trends and develop proactive and/or mitigation measures accordingly. - Provide training on regulatory sciences within RA department and cross-functions. Supervisory Responsibility - None Competencies - Planning and Organizing - Teamwork - Problem Solving - Quality - Judgement - Dependability - Strong Interpersonal Skills 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. Education and/or Experience Master's or Ph.D. degree in life sciences; over 5 years related experience in product development and/or regulatory CMC or equivalent combination of education and experience. Expertise in and experience with complex /combination generics (peptides), biologics and/or biosimilars are highly preferred. Communication Skills Ability to author reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. Mathematical Skills Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. Reasoning Ability Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Travel - Not expected Computer Skills Microsoft Office, Adobe Systems (Pro, Acrobat DC), and Regulatory publishing systems (DocuBridge). Equal Opportunity Employer: Meitheal Pharmaceuticals is an Equal Opportunity Employer. We welcome and encourage applications from all qualified individuals, including minorities, women, veterans, and individuals with disabilities.

Two Chairs is building a new kind of mental health system based on the idea that the status quo isn’t good enough. Industry-best clinician experiences, better client outcomes, groundbreaking innovation, and access to the highest quality care are how we’ll raise the bar for the entire industry. With that, we're excited and honored to have been recognized as a 2025 Great Place to Work and 2025 Fortune's Best Workplaces in Healthcare. One of our company values is "Embrace Differences" and diversity, equity, inclusion, and belonging are the principles guiding how we build our business and teams. We encourage interested candidates from all backgrounds to apply even if they don't think they meet some expectations of the role. Why Two Chairs is consistently a Great Place to Work - Consistent Pay: Earn an hourly rate of $62-$96 with semi-monthly pay. This is based on clinical experience, place of residence, and overall qualifications. Guaranteed base rate with incentive potential after initial ramp period. - Truly Flexible Work: Work remotely with a schedule that fits your life: no nights, no weekends, no on-call responsibilities. We also provide paid administrative time so documentation doesn’t follow you home. - Mission-Driven, Clinician-Led: We’re dedicated to creating a world where everyone has access to exceptional mental healthcare. Clinical decisions are made by clinicians for clinicians, ensuring you’re supported by a team that is focused on centering the client and enabling clinicians to deliver exceptional care. - Clinical Excellence Comes First: You’ll join a deeply collaborative environment, with access to physician partners, therapists, and crisis support services. Our integrated platform provides tools that enable measurement-based care, clinical decision support, and seamless information sharing. What You’ll Do - Conduct 60-minute psychiatry assessments and 30 minute follow-up sessions remotely. - Prescribe and manage psychiatric medications, including controlled substances, in accordance with state and federal regulations. - Integrate brief psychotherapy when clinically appropriate to support your clients in reaching their goals efficiently and sustainably. - Collaborate with physicians and clinical leadership for support, escalation, and continued learning. - Partner with therapists and other providers through integrated care plans, shared treatment insights, and team consultation spaces. - Use data-informed tools and measurement-based care to tailor treatment plans and improve outcomes. - Contribute to a growing, diverse community of clinicians committed to redefining mental health care. What success looks like In your first 90 days You will become comfortable with Two Chairs systems, processes, and teams, supported by an onboarding team and clinical leadership. You will gradually build a caseload and deliver exceptional mental health care. You will collaborate with team members and help refine workflows and care protocols. By the end of your first year You will have established a robust caseload of clients and delivered exceptional care, as evidenced by clinical outcomes. You will have made contributions to our program and to a world where everyone has access to exceptional mental health care. What We Offer - Compensation you can count on: - Competitive Pay: Hourly rate of $62-$96 based on clinical experience, place of residence, and overall qualifications - Guaranteed Onboarding Support: 100% of hourly rate during your initial 90-day ramp period while you build your caseload - Sustainable Base + Incentive: Following the ramp period, you’ll receive a guaranteed base (80% of your hourly rate) plus an incentive structure that rewards clinical productivity and the integration of psychotherapy. - Comprehensive Coverage: we pay for administrative time, clinical consultations, trainings, and no-shows. - Long-term Growth: Eligibility for annual performance-based merit increases - Comprehensive Benefits: - Sick leave - Access to 401(k) retirement plan options - Credentialing and cross-licensing support - License renewal fee reimbursement - Free Continuing Medical Education (CME) access - Technology package including laptop, EHR system, HIPAA compliant video platform, and more - Malpractice Insurance provided - Flexible Schedule: - Part-time, W2 position (up to 8 hours per week) with opportunity for increased hours over time. - Expect to spend ~75% of time on direct client care and ~25% focused on admin/ supervisory work. The balance may vary based on team needs. - Build a schedule that works for you within our operating hours of M-F, 8am-8pm. - Start date: mid-August 2026 - Clinical Coverage: - Backup coverage, so your clients are supported when you’re away - Dedicated 24/7 crisis line available for immediate risk assessments and arrangement of in-person interventions if needed Compensation Ranges - Zone 1 / New York City and San Francisco | $80-108/hour - New hires can reasonably expect an offer between $80 and $96/hour - Zone 2 / Portland, Boston, Chicago, Washington DC, New Jersey, Washington, all other CA locations | $70-95/hour - New hires can reasonably expect an offer between $70 and $86/hour - Zone 3 / Miami, Philadelphia, Denver, Austin, Dallas, Houston | $67-91/hour - New hires can reasonably expect an offer between $67 and $81/hour - Zone 4 / All other locations | $62-87/hour - New hires can reasonably expect an offer between $62 and $76/hour Who You Are - A board-certified Psychiatric Mental Health Nurse Practitioner (PMHNP-BC) - 2+ years of experience providing mental health services as a PMHNP - Licensed to practice in Washington as a PMHNP (additional licensure a plus!) - Open to obtaining additional state licenses to support company expansion. Two Chairs covers all costs and provides full administrative support for the cross-licensing process. - Active DEA license in Washington - Experienced in delivering remote telepsychiatry services - Passionate about high-quality, measurement-based, collaborative care - Eager to join a community of clinicians who are driven by purpose and help us build upon our psychiatry program to improve our services and systems continually - Able to start in mid-August 2026 Please stay alert for job scams: All communication will come from official Two Chairs email domains (@twochairs.com or @twochairscareers.com). See tips from the FTC to avoid job scams: https://www.consumeraffairs.com/news/ftc-offers-tips-on-avoiding-job-scams-041321.html #LI-REMOTE

Two Chairs is building a new kind of mental health system based on the idea that the status quo isn’t good enough. Industry-best clinician experiences, better client outcomes, groundbreaking innovation, and access to the highest quality care are how we’ll raise the bar for the entire industry. With that, we're excited and honored to have been recognized as a 2025 Great Place to Work and 2025 Fortune's Best Workplaces in Healthcare. One of our company values is "Embrace Differences" and diversity, equity, inclusion, and belonging are the principles guiding how we build our business and teams. We encourage interested candidates from all backgrounds to apply even if they don't think they meet some expectations of the role. Why Two Chairs is consistently a Great Place to Work - Consistent Pay: Earn an hourly rate of $62-$96 with semi-monthly pay. This is based on clinical experience, place of residence, and overall qualifications. Guaranteed base rate with incentive potential after initial ramp period. - Truly Flexible Work: Work remotely with a schedule that fits your life: no nights, no weekends, no on-call responsibilities. We also provide paid administrative time so documentation doesn’t follow you home. - Mission-Driven, Clinician-Led: We’re dedicated to creating a world where everyone has access to exceptional mental healthcare. Clinical decisions are made by clinicians for clinicians, ensuring you’re supported by a team that is focused on centering the client and enabling clinicians to deliver exceptional care. - Clinical Excellence Comes First: You’ll join a deeply collaborative environment, with access to physician partners, therapists, and crisis support services. Our integrated platform provides tools that enable measurement-based care, clinical decision support, and seamless information sharing. What You’ll Do - Conduct 60-minute psychiatry assessments and 30 minute follow-up sessions remotely. - Prescribe and manage psychiatric medications in accordance with state and federal regulations. - Integrate brief psychotherapy when clinically appropriate to support your clients in reaching their goals efficiently and sustainably. - Collaborate with physicians and clinical leadership for support, escalation, and continued learning. - Partner with therapists and other providers through integrated care plans, shared treatment insights, and team consultation spaces. - Use data-informed tools and measurement-based care to tailor treatment plans and improve outcomes. - Contribute to a growing, diverse community of clinicians committed to redefining mental health care. What success looks like In your first 90 days You will become comfortable with Two Chairs systems, processes, and teams, supported by an onboarding team and clinical leadership. You will gradually build a caseload and deliver exceptional mental health care. You will collaborate with team members and help refine workflows and care protocols. By the end of your first year You will have established a robust caseload of clients and delivered exceptional care, as evidenced by clinical outcomes. You will have made contributions to our program and to a world where everyone has access to exceptional mental health care. What We Offer - Compensation you can count on: - Competitive Pay: Hourly rate of $62-$96 based on clinical experience, place of residence, and overall qualifications - Guaranteed Onboarding Support: 100% of hourly rate during your initial 90-day ramp period while you build your caseload - Sustainable Base + Incentive: Following the ramp period, you’ll receive a guaranteed base (80% of your hourly rate) plus an incentive structure that rewards clinical productivity and the integration of psychotherapy. - Comprehensive Coverage: we pay for administrative time, clinical consultations, trainings, and no-shows. - Long-term Growth: Eligibility for annual performance-based merit increases - Comprehensive Benefits: - Sick leave - Access to 401(k) retirement plan options - Credentialing and cross-licensing support - License renewal fee reimbursement - Free Continuing Medical Education (CME) access - Technology package including laptop, EHR system, HIPAA compliant video platform, and more - Malpractice Insurance provided - Supervising Psychiatrist fees covered - Flexible Schedule: - Part-time, W2 position (up to 8 hours per week) with opportunity for increased hours over time. - Expect to spend ~75% of time on direct client care and ~25% focused on admin/ supervisory work. The balance may vary based on team needs. - Build a schedule that works for you within our operating hours of M-F, 8am-8pm. - Start date: mid-August 2026 - Clinical Coverage: - Backup coverage, so your clients are supported when you’re away - Dedicated 24/7 crisis line available for immediate risk assessments and arrangement of in-person interventions if needed Compensation Ranges - Zone 1 / New York City and San Francisco | $80-108/hour - New hires can reasonably expect an offer between $80 and $96/hour - Zone 2 / Portland, Boston, Chicago, Washington DC, New Jersey, Washington, all other CA locations | $70-95/hour - New hires can reasonably expect an offer between $70 and $86/hour - Zone 3 / Miami, Philadelphia, Denver, Austin, Dallas, Houston | $67-91/hour - New hires can reasonably expect an offer between $67 and $81/hour - Zone 4 / All other locations | $62-87/hour - New hires can reasonably expect an offer between $62 and $76/hour Who You Are - A board-certified Psychiatric Mental Health Nurse Practitioner (PMHNP-BC) - 2+ years of experience providing mental health services as a PMHNP - Licensed to practice in Texas as a PMHNP (additional licensure a plus!) - Open to obtaining additional state licenses to support company expansion. Two Chairs covers all costs and provides full administrative support for the cross-licensing process. - Experienced in delivering remote telepsychiatry services - Passionate about high-quality, measurement-based, collaborative care - Eager to join a community of clinicians who are driven by purpose and help us build upon our psychiatry program to improve our services and systems continually - Able to start in mid-August 2026 Please stay alert for job scams: All communication will come from official Two Chairs email domains (@twochairs.com or @twochairscareers.com). See tips from the FTC to avoid job scams: https://www.consumeraffairs.com/news/ftc-offers-tips-on-avoiding-job-scams-041321.html #LI-REMOTE

• Responsible for influencing the use of the defined process and procedures by the execution teams as part of their delivery approach at each phase of the program. • Responsible for influencing the use of the agreed information management system by the execution teams as part of their delivery approach at each phase of the program. • Responsible for gathering design requirements of the client, end user and stakeholders and documenting in a program-specific brief as part of the initial definition phase. • Responsible for validating corporate standardization with respect to design to achieve efficiency and best value. • Responsible for identifying delivery and execution of stakeholders, maintaining communication, influencing stakeholder involvement, and obtaining input as required. • Responsible for the day-to-day stakeholder interface assuring that projects are delivered to time, cost and quality targets. • Responsible for obtaining all project funding required prior to the initiation of capital works aligned to governance structure. • Responsible for defining the contracting strategy which considers all aspects of the requirements and motivates performance and assures the delivery of required outcomes by the execution teams. • Responsible for defining the procurement approach that is objectively managed and leverages data as part of pre-qualification, tender and evaluation through to contract award and assures the delivery of required outcomes by the execution teams. • Develop the master schedule based on historical data and assure that the execution teams are progressing the project schedules. • Responsible for monitoring that the collection, storage, and dissemination of project information is being undertaken by the execution teams. • Responsible for monitoring connected projects, risks and opportunities and assessment of their cost and schedule impact, including the identification and implementation of mitigation plans for critical risks and opportunities. • Responsible for monitoring the implementation of a robust process which actively manages change, assessing scope, time, cost, and quality prior to a change approval decision. • Responsible for monitoring that the process for handing projects over to operational teams in an effective integrated manner is being undertaken by the execution teams. • Responsible for monitoring that the management of the efficient closeout of a project, including an analysis of outturn cost, schedule, and lessons learned exercises, is being undertaken by the execution team. • Responsible for the management, identification and implementation of strategic and program improvement initiatives, lessons learnt, and best practices.