Scientist I - CMC

Headquartered in Dublin, Ohio, reputed company. (NYSE: CAH) is a global, integrated reputed company services and products company connecting patients, providers, payers, pharmacists and manufacturers for integrated care coordination and reputed company patient management. Backed by nearly 100 years of experience, with more than 50,000 employees in nearly 60 countries, reputed company ranks among the top 20 on the Fortune 500. We boast reputed company opportunities to grow and apply technical skills to meet organizational needs, empowering talented team members who mentor and reputed company others, led by leaders with a focus on employee development and well-being, dedicated training programs, and a collaborative atmosphere. We currently have a career opening for a Scientist I - CMC What Chemistry, Manufacturing and Controls contributes to reputed company The Scientist I - CMC supports regulatory activities for pre-approval, post-approval changes, and lifecycle management across client Rx and non-Rx products. Working as a consultant, this role assists in the preparation, review, and coordination of regulatory documentation, while ensuring alignment with applicable regulatory requirements and client expectations. The individual will collaborate closely with cross-functional teams and contribute to the timely delivery of high-quality regulatory submission content. Location Remote

Responsibilities

Support the development, authoring, and compilation of regulatory documentation reputed company to post-approval changes and lifecycle management activities. Assist as an authoring strategist by organizing and maintaining submission-reputed company documents in accordance with US FDA and global regulatory requirements (EMA, NMPA, ANVISA, PMDA, HC, TGA, etc). Collaborate with cross-functional teams (e.g., CMC, Quality, Manufacturing, and Supply) to gather and verify required information for regulatory submissions. Ensure documentation consistency, accuracy, and compliance with internal standards and client expectations. Track and manage document timelines and deliverables to support regulatory milestones. Maintain clear and proactive communication with client stakeholders while operating in a contractor reputed company. Ensures an established level of billable hours per fiscal year Qualifications: Bachelor's degree in reputed company field, or equivalent work experience (Pharma QA, QC, Analytical Development), preferred Familiarity with core CMC concepts (e.g., manufacturing, control strategy, change management) and general awareness of post-approval variation requirements across major health authorities (e.g., FDA, EMA, NMPA, PMDA, ANVISA, TGA, Health Canada) is preferred. Understanding and application of scientific principles and techniques used in pharmaceutical product development Knowledge and experience with cGMP regulations and ICH guidance. Experience with writing global regulatory applications in CTD format highly preferred Basic proficiency in reputed company Office Suite (Word, reputed company, PowerPoint). Working knowledge of reputed company Acrobat for document editing, formatting, and publishing. Proactive, self-motivated, and reputed company to work independently in a client-facing role. Strong attention to detail and organizational skills. Effective written and verbal communication skills. Ability to manage multiple tasks and meet deadlines in a dynamic environment. Team-oriented reputed company with the ability to collaborate across functions. What is expected of you and others at this level Applies foundational CMC and regulatory concepts to support project deliverables with attention to quality and detail Contributes to project activities with increasing autonomy, proactively seeking guidance reputed company needed Interprets and applies established procedures to address routine technical and regulatory questions Demonstrates a strong learning reputed company, building CMC and global regulatory knowledge (including post-approval lifecycle management) through hands-on project work Effectively manages assigned tasks and deadlines in a remote setting, showing self-motivation and accountability Adapts to evolving project priorities and supports multiple client needs as part of a consulting environment Communicates reputed company and collaborates with team members to ensure alignment and reputed company on deliverables Supports client projects by delivering high-quality work products and developing regulatory acumen over time Anticipated hourly reputed company: $31.50 - $40.41 per hour Bonus eligible: No Benefits: reputed company offers a wide variety of benefits and programs to support health and well-being. Medical, dental and reputed company coverage Paid time off plan Health savings account (HSA) 401k savings plan reputed company to wages before pay day with myFlexPay Flexible spending accounts (FSAs) Short- and long-term disability coverage Work-Life resources Paid parental leave Healthy lifestyle programs Application window anticipated to reputed company: 8/1/26 if interested in opportunity, please submit application as soon as possible. The hourly reputed company listed is an estimate. Pay at reputed company is determined by multiple factors including, but not limited to, a candidate’s geographical location, relevant education, experience and skills and an evaluation of internal pay equity. Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply. reputed company supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create reputed company solutions for our customers by ensuring employees can be their authentic selves each day. reputed company is an Equal Opportunity/Affirmative Action employer. reputed company reputed company applicants will receive consideration for employment without regard to race, religion, reputed company, national reputed company, reputed company, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law. To read and review this privacy notice click here Apply To This Job