Manager, Regulatory Affairs CMC
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Location
REMOTE
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Sector:
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Job type:
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Contact:
Antoinette Miller
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Contact email:
a.miller@hamlynwilliams.com
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Salary high:
0
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Salary low:
0
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Published:
2 months ago
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Expiry date:
2022-05-02
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Startdate:
ASAP
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):
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Manages several projects simultaneously with an emphasis on CMC while adapting to changing project priorities
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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)
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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
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Produces high quality regulatory submissions appropriate for electronic publishing systems
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Researches and provides analysis of current regulations and guidance
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Expedites review and/or approval of submissions
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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
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Ensures the company is adhering to all applicable government regulations
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May be required to directly interface with US and international regulatory authorities on specific projects
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Participates in the project team meetings and offers advice pertinent to regulations
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Responsible for assigned activities with the project team. Performs other duties as required
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Other duties as assigned
Requirements:
#LI- AM2
#LI- AM2
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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
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Master’s degree in Life/Health Sciences or related field and 6+ years of similar experience noted above OR
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PhD and 4+ years of similar experience noted above
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Ability to work independently with minimal direction, including functional representation within project teams and committees in order to attain group goals
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Strong knowledge of FDA regulations, including current Good Manufacturing Practices
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Experience with electronic filing (eCTD), electronic document management systems and with document review and approval processes
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Has knowledge of best practices in the functional discipline and familiarity with the broader underlying concepts of related business disciplines
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Works to improve tools and processes within functional area
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Developing reputation inside the company as it relates to area of expertise
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Ability to work as part of and lead multiple teams
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Exhibits leadership skill and ability, typically leads lower levels and/or indirect teams
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Excellent computer skills
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Excellent problem-solving, analytical thinking skills
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Sees broader picture, impact on multiple departments/divisions
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Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
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Excellent project management skills and ability to work in a cross functional environment and handle multiple tasks