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 and through this is responsible for achieving results that impact the success of the department and company.

Your Contributions (include, but are not limited to):

• Manages several projects simultaneously with an emphasis on CMC while adapting to changing project priorities

• Maintains all CMC aspects of US regulatory filings and clinical trial applications outside the US, ensuring that they remain compliant with all 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 quality regulatory submissions appropriate 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 for product development, including technical documentation and change controls

• Ensures the company is adhering to all applicable government regulations

• May be required to communicate with US and international regulatory authorities on specific projects

• 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 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 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 related business disciplines

• Works to improve tools and processes within functional area

• Developing reputation inside the company as it relates to area of expertise

• Ability to work as part of and lead multiple program teams

• Excellent computer skills

• Excellent problem-solving, analytical thinking skills

• Sees broader picture, impact on multiple departments/divisions

• Ability to meet multiple deadlines across a variety of projects/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 within project teams and committees in order to attain group goals

• Knowledge of FDA regulations, including current 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 direct interaction with FDA

Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety 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 what we have outlined in the job description.

The annual base salary we reasonably expect to pay is $132,700.00-$182,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered 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 in accordance with the terms and conditions of the applicable plans.