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Job

Manager, Regulatory Affairs CMC

  • Location

    REMOTE

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Antoinette Miller

  • Contact email:

    a.miller@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    2 months ago

  • Expiry date:

    2022-05-02

  • Startdate:

    ASAP

The company’s diverse portfolio includes FDA-approved treatments, as well as clinical programs in multiple therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science.

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

  •