Meitheal Pharmaceuticals

Title: Product Manager Location: Chicago, IL • Commercial Operations - Generics Job Type Full-time Description ABOUT MEITHEAL PHARMACEUTICALS 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 75 U.S. FDA-approved products across numerous therapeutic areas including anti-infectives, oncolytics, intensive care, and fertility. As of April 2026, Meitheal, directly or through its partners, has 32 products in the research and development phase, 9 products planned for launch in 2026, 4 products in clinical trial phases, and 13 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 regularly as one of Crain’s Fast 50 in Chicago, and in the top 100 of Crain’s Best Places to Work in Chicago from 2022 to 2025, Meitheal emulates the traditional Irish guiding principle we are named for—working together toward a common goal, for the greater good. Learn more about who we are and what we do at www.meithealpharma.com. 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 The estimated salary range reflects an anticipated range for this position of $75,000 to $95,000. 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. Position Summary The Product Manager provides operational leadership for short- and long-term plans in real time for on-market and pipeline products within Meitheal's designated therapeutic portfolio. The Product Manager is a highly motivated, creative and organized individual, a vital member of a team dedicated to operational execution of short-and long-term financial plans for our product portfolio. Essential Duties and Responsibilities • Develops and maintains an understanding of assigned product portfolio, including current and future market trends, landscape, customer mix and competitors. • Supports all short-term planning through commercial forecasts and budget activities. • Develops recommendations and brings forward key decisions needed from Senior Management in support of short and long-term financial goals for our product portfolio. • Actively works with Finance and Pricing teams to track financial performance and identify and recommend strategies to amplify successes and mitigate gaps. • Provides pricing recommendations to help maximize product sales and gross profits. • Identifies opportunities for increasing market share by assessing competitive landscape and patient needs. • Assists with completion of product and supply chain information for RFIs, RFPs, and bid documents, as well as corporate strategy documents. • Responsible for accurate forecasting and tactical execution of plans to mitigate financial risks for the category, including but not limited to, allocation/trade-off analyses, discussions, decisions and short-dated product risks. •Go-to person for national accounts, sales, trade relations and contract marketing for product attribute information, product availability, sales collaterals, RFI completion and other internal data sources. •Works with manufacturing, supply chain, and customer service to ensure accurate and timely sales forecasting for new and existing products, including performing a monthly analysis versus marketing forecast to manage variances and participate in pre-S&OP process. •Partners with Sr. Director Product Management to provide support and development of analysis and presentations to senior management for creation and reporting of short- and long-term financial plans. 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. • Experience with supporting sales channels. • Ability to build positive working relationships. • High level of business acumen, analysis and judgement. • Solid understanding of sales, marketing or product management, preferably in the healthcare industry. • Strong analytical & presentation skills, proficiency in Excel, business intelligence (BI) tools and attention to detail. • Ability to work independently and make key decisions. • Excellent planning, organization and time management skills, including the ability to support and prioritize multiple projects. • Generic pharmaceutical Industry knowledge preferred Education and/or Experience: • Bachelor’s degree in business or BS/MS in life sciences preferred, with experience in sales, marketing, or product management, or equivalent skills and experience required. • A minimum of 2 years of experience in the pharmaceutical industry. Travel Up to 10% domestic travel. Computer Skills Microsoft Word, PowerPoint, Excel, Project Management, Business Intelligence and Visualization tools (Tableau, IQVIA, SFDC). AAP/EEO Statement Meitheal Pharmaceuticals is an Equal Opportunity Employer. We welcome and encourage applications from all qualified individuals, including minorities, women, veterans, and individuals with disabilities.

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.