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 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 directly interface 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:

#LI- AM2

#LI- AM2

• BS/BA degree in Life/Health Sciences or related field and 8+ years of Regulatory Affairs experience in a pharmaceutical company with focus on CMC activities. Experience managing external contract services, and direct interaction with FDA. OR

• Master’s degree in Life/Health Sciences or related field and 6+ years of similar experience noted above OR

• PhD and 4+ years of similar experience noted above

• Ability to work independently with minimal direction, including functional representation within project teams and committees in order to attain group goals

• Strong 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

• 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 teams

• Exhibits leadership skill and ability, typically leads lower levels and/or indirect 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

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