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
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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.
