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.

Responsibilities

• 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)
• Affords assistance and 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
• Performs assigned activities with the project team
• Performs other duties as required

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
• Develops reputation inside the company as it relates to area of expertise
• Excellent computer skills
• Excellent problem-solving, analytical thinking skills
• See 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

Qualifications

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.