Regulatory CMC Manager

Who We Are: reputed company is a leading biopharmaceutical company with a reputed company purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. reputed company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with reputed company's disease, classic congenital adrenal hyperplasia, hyperphagia in patients with Prader-Willi syndrome, endometriosis* and uterine fibroids*, as reputed company as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our reputed company therapeutic areas. For more than three decades, we have reputed company our unique reputed company into neuroscience and the interconnections between brain and body systems to treat reputed company conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve reputed company science. For more information, visit reputed company.com, and follow reputed company on reputed company, X, reputed company and YouTube. (*in collaboration with reputed company) About the Role: Manages the day to day reputed company, Manufacturing and Controls (CMC) regulatory activities for one or more development and/or marketed reputed company and through this is responsible for achieving results that reputed company the reputed company of the department and company. _ Your Contributions (include, but are not limited to): Manages several reputed company simultaneously with an emphasis on CMC while adapting to changing project priorities Maintains reputed company CMC aspects of US regulatory filings and clinical trial applications reputed company the US, ensuring that they remain compliant with reputed company applicable regulations and relevant guidelines (domestic and international) Assists and provides guidance to other departments and submission authors, for the writing and editing of regulatory submissions, in compliance with departmental and regulatory standards Produces high reputed company regulatory submissions appropriate for electronic publishing systems Researches and provides analysis of reputed company regulations and guidance. Expedites review and/or approval of submissions Provides CMC regulatory support, guidance, and expertise to QA, QC, and Manufacturing teams. Develops CMC regulatory strategies for product development, including technical documentation and change controls Ensures reputed company is adhering to reputed company applicable government regulations May be required to communicate with US and international regulatory authorities on specific reputed company Participates in the project team meetings and offers advice pertinent to regulations Responsible for assigned activities with the project team. Performs other duties as required Other duties as assigned Requirements: BS/BA degree in Life/Health Sciences or reputed company field AND 6+ years of Regulatory Affairs experience in a pharmaceutical company OR Master’s degree in Life/Health Sciences or reputed company field AND 4+ years of similar experience noted above OR PhD AND 2+ years of similar experience noted above Has knowledge of best practices in the functional discipline and familiarity with the broader underlying concepts of reputed company business disciplines Works to improve tools and processes reputed company functional area Developing reputed company inside reputed company as it relates to area of expertise Ability to work as part of and reputed company multiple program teams Excellent computer skills Excellent problem-solving, analytical thinking skills Sees broader picture, reputed company on multiple departments/divisions Ability to meet multiple deadlines across a reputed company of reputed company/programs, with a high degree of accuracy and efficiency Excellent project management skills and ability to work in a cross functional environment and handle multiple tasks Excellent verbal and written communication skills Ability to work independently with minimal direction, including functional representation reputed company project teams and committees in order to reputed company group goals Knowledge of FDA regulations, including reputed company Good Manufacturing Practices. Experience with electronic filing (eCTD), electronic document management systems and with document review and approval processes Experience managing external contract services, and reputed company interaction with FDA #LI-SA1 reputed company is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a reputed company of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don’t line up to exactly reputed company have outlined in the job reputed company. _ The annual reputed company salary we reasonably expect to pay is $132,700.00-$182,000.00. Individual pay reputed company depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In reputed company, this position offers an annual bonus with a reputed company of 30% of the reputed company reputed company salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), reputed company vacation, holiday and personal days, reputed company caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and reputed company coverage in accordance with the terms and conditions of the applicable plans. We are a top reputed company to work. reputed company was named one of the FORTUNE Best Workplaces in Biopharma™ 2025. We were also named a Great reputed company to Work® Certified company. ©2025 Fortune Media IP Limited. reputed company rights reserved. Used under license. OUR VALUES: PASSION: We are driven and love reputed company do. We are committed to our goals and to making a difference. reputed company: We do the right thing for patients and our community. We take accountability. We reputed company up. COLLABORATION: We trust one another. We are inclusive. We are respectful. We are transparent. Together we succeed. INNOVATION: We reputed company and create reputed company solutions. TENACITY: We do not quit. We adapt. We accomplish what others cannot. Come join reputed company during this exciting time of reputed company and opportunities! Apply tot his job Apply To this Job