Regulatory CMC Manager

The role is for a CMC Regulatory Affairs Manager, responsible for day‑to‑day internal regulatory activities across development and marketed projects. Responsibilities Manage multiple projects simultaneously with emphasis on CMC while adapting to changing priorities. Maintain all CMC aspects of US regulatory filings and clinical trial applications outside the US. Assist and provide guidance to other departments and submission authors. Produce high‑quality regulatory submissions appropriate for electronic publishing systems. Research and provide analysis of current regulations and guidance. Expedite review and/or approval of submissions. Provide CMC regulatory support to QA, QC, and manufacturing teams. Develop CMC regulatory strategies for product development, including technical documentation and change controls. Ensure compliance with all applicable government regulations. Communicate with US and international regulatory authorities as required. Participate in project team meetings and provide regulatory advice. Perform other duties as required. Qualifications BS/BA in Life/Health Sciences or related field AND 6+ years of regulatory affairs experience in a pharmaceutical company. OR Master’s degree 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 and familiarity with related business concepts. Ability to improve tools and processes within functional area. Developing reputation inside the company in the area of expertise. Excellent computer skills. Excellent problem‑solving, analytical thinking skills. Ability to see the broader picture and impact on multiple departments/divisions. Ability to meet multiple deadlines across a variety of projects/programs with high accuracy. Excellent project management skills and ability to work in a cross‑functional environment. Excellent verbal and written communication skills. Ability to work independently with minimal direction. Knowledge of FDA regulations, including current Good Manufacturing Practices. Experience with electronic filing (eCTD), electronic document management systems and document review and approval processes. Experience managing external contract services and direct interaction with FDA. Neurocrine Biosciences is an EEO/Disability/Vets employer. Compensation and Benefits The annual base salary is expected to be 132,700.00-182,000.00. The position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in an equity‑based long‑term incentive program. Benefits include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. #J-18808-Ljbffr Neurocrine Biosciences