Fate Therapeutics
Senior ManagerAssociate Director, Regulatory Operations
Fate Therapeutics, San Diego, California, United States, 92189
We are seeking a highly skilled Senior Manager / Associate Director of Regulatory Operations to lead the planning coordination and execution of global regulatory submissions across our clinical pipeline. This individual will play a critical role in ensuring high-quality compliant submissions and supporting the development and continuous improvement of our regulatory infrastructure. This is an exempt full-time position located at our corporate headquarters in San Diego CA.
Responsibilities
Collaborate with Regulatory Affairs cross-functional teams and external partners to plan, prepare and submit regulatory health authority dossiers and amendments including INDs CTAs IMPDs and marketing applications in electronic or paper formats as required (including formatting life-cycling and archiving).
Oversee in-house technical aspects for health authority submissions e.g. eCTD document granularity utilization of content templates document formatting eCTD application location and lifecycle assignment publishing QC validation and transmission to regulatory health authorities (e.g. FDA ESG EMA IRIS CTIS).
Serve as system owner for regulatory information platforms and tools (e.g. eCTD publishing systems EDMS template libraries) and ensure appropriate governance and user support.
Maintain up-to-date expertise in electronic submission requirements and computerized system validation standards.
Partner with IT to ensure regulatory systems are implemented validated and maintained in compliance with SOPs and applicable regulations.
Identify potential risks to submission plans and propose / execute risk mitigation strategies.
Manage tracking and archiving of regulatory communications and submissions.
Support budgeting and forecasting for function and Regulatory Affairs department.
Provide recommendations on resource needs for regulatory operations and records management activities including the need for outsourcing (e.g. eCTD or SPL vendor).
Represent Regulatory Operations in project teams to support submission planning and ensure coordination of system development activities.
Qualifications
B.S. or M.S. degree in IT or Life Sciences related field with 7 years of relevant and progressive experience in Regulatory Operations.
Extensive experience implementing validating and managing eCTD publishing systems and EDMS technology (Veeva RIM Suite preferred); familiarity with Lorenz docuBridge and DXC Toolbox a plus.
Expert knowledge of global regulatory health authority formatting publishing and transmittal requirements for eCTD submissions.
Ability to clearly present and articulate regulatory requirements.
Knowledge of computer system validation requirements for GxP systems.
Familiarity with dossier content requirements for global regulatory health authority submissions; strong knowledge of US and EU content requirements is preferred.
Knowledge of CDISC standards and FDA Study Data Technical Conformance Guide (SDTM ADaM SEND); experience preparing Study Data Standardization Plans.
Advanced proficiency using MS Word MS SharePoint Adobe Acrobat Professional as well as experience with MS Excel MS PowerPoint and MS Project or Smartsheet.
Self-starter with strong track record of working both independently and in collaboration with program stakeholders.
High attention to detail and ability to work on multiple projects with tight deadlines.
Strong project management and organizational skills with demonstrated ability to absorb new technical / strategic information and be flexible to adapt accordingly.
Working Conditions and Physical Requirements
Subject to extended periods of sitting and standing vision to monitor and moderate noise levels.
Compensation
The salary offer will be based on a variety of factors including level experience qualifications internal equity and location.
Fate offers a competitive employment package that includes an annual bonus equity and a generous benefits package.
The anticipated salary range for this role is $160000 - $178000.
The preceding job description indicates the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required from time to time.
Equal Employment Opportunity Fate Therapeutics Inc. is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees.
#J-18808-Ljbffr
Responsibilities
Collaborate with Regulatory Affairs cross-functional teams and external partners to plan, prepare and submit regulatory health authority dossiers and amendments including INDs CTAs IMPDs and marketing applications in electronic or paper formats as required (including formatting life-cycling and archiving).
Oversee in-house technical aspects for health authority submissions e.g. eCTD document granularity utilization of content templates document formatting eCTD application location and lifecycle assignment publishing QC validation and transmission to regulatory health authorities (e.g. FDA ESG EMA IRIS CTIS).
Serve as system owner for regulatory information platforms and tools (e.g. eCTD publishing systems EDMS template libraries) and ensure appropriate governance and user support.
Maintain up-to-date expertise in electronic submission requirements and computerized system validation standards.
Partner with IT to ensure regulatory systems are implemented validated and maintained in compliance with SOPs and applicable regulations.
Identify potential risks to submission plans and propose / execute risk mitigation strategies.
Manage tracking and archiving of regulatory communications and submissions.
Support budgeting and forecasting for function and Regulatory Affairs department.
Provide recommendations on resource needs for regulatory operations and records management activities including the need for outsourcing (e.g. eCTD or SPL vendor).
Represent Regulatory Operations in project teams to support submission planning and ensure coordination of system development activities.
Qualifications
B.S. or M.S. degree in IT or Life Sciences related field with 7 years of relevant and progressive experience in Regulatory Operations.
Extensive experience implementing validating and managing eCTD publishing systems and EDMS technology (Veeva RIM Suite preferred); familiarity with Lorenz docuBridge and DXC Toolbox a plus.
Expert knowledge of global regulatory health authority formatting publishing and transmittal requirements for eCTD submissions.
Ability to clearly present and articulate regulatory requirements.
Knowledge of computer system validation requirements for GxP systems.
Familiarity with dossier content requirements for global regulatory health authority submissions; strong knowledge of US and EU content requirements is preferred.
Knowledge of CDISC standards and FDA Study Data Technical Conformance Guide (SDTM ADaM SEND); experience preparing Study Data Standardization Plans.
Advanced proficiency using MS Word MS SharePoint Adobe Acrobat Professional as well as experience with MS Excel MS PowerPoint and MS Project or Smartsheet.
Self-starter with strong track record of working both independently and in collaboration with program stakeholders.
High attention to detail and ability to work on multiple projects with tight deadlines.
Strong project management and organizational skills with demonstrated ability to absorb new technical / strategic information and be flexible to adapt accordingly.
Working Conditions and Physical Requirements
Subject to extended periods of sitting and standing vision to monitor and moderate noise levels.
Compensation
The salary offer will be based on a variety of factors including level experience qualifications internal equity and location.
Fate offers a competitive employment package that includes an annual bonus equity and a generous benefits package.
The anticipated salary range for this role is $160000 - $178000.
The preceding job description indicates the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required from time to time.
Equal Employment Opportunity Fate Therapeutics Inc. is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees.
#J-18808-Ljbffr