Regulatory CMC Manager

About the Role Manages the day-to-day Chemistry, Manufacturing and Controls (CMC) regulatory activities for one or more development and/or marketed projects, impacting departmental and company success. Your Contributions Manages several projects simultaneously with an emphasis on CMC while adapting to changing project priorities Maintains CMC aspects of US regulatory filings and clinical trial applications outside the US, ensuring compliance with applicable domestic and international regulations/guidelines Assists and guides other departments and submission authors on writing/editing regulatory submissions to departmental/regulatory standards Produces high-quality regulatory submissions for electronic publishing systems Researches and provides analysis of current 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 (technical documentation and change controls) Ensures adherence to applicable government regulations May communicate with US and international regulatory authorities on specific projects Participates in project team meetings and advises on regulatory matters Performs other duties as required Requirements BS/BA in Life/Health Sciences or related field AND 6+ years of Regulatory Affairs experience in a pharmaceutical company OR Master’s in Life/Health Sciences or related field AND 4+ years of similar experience OR PhD AND 2+ years of similar experience Knowledge of best practices in the functional discipline; familiarity with broader business concepts Ability to work as part of and lead multiple program teams Excellent computer, problem-solving/analytical, and project management skills Ability to meet multiple deadlines with accuracy/efficiency Excellent verbal and written communication; ability to work independently with minimal direction Knowledge of FDA regulations, including current Good Manufacturing Practices Experience with eCTD, electronic document management systems, and document review/approval processes Experience managing external contract services and direct interaction with FDA Benefits Retirement savings plan (with company match), paid vacation/holidays/personal days, paid caregiver/parental and medical leave, and health benefits (medical, prescription drug, dental, vision) Compensation Annual base salary: $132,700.00–$182,000.00; annual bonus target 30% of earned base salary; eligibility for equity-based long-term incentive program #J-18808-Ljbffr Dormont Manufacturing Co