• Senior Regulatory Operations Manager/Regulatory Operations Manager

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@ MacroGenics
  • Post Date : Jan 10, 2022
  • Apply Before : Mar 22, 2022
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Job Description

Summary of Position

The Sr. Regulatory Operations Manager/Regulatory Operations Manager position is responsible for assisting the Director, Regulatory Operations in enforcing MacroGenics regulatory submission standards and current electronic submission guidelines/requirements. The incumbent in this role will be responsible to managing day-to-day submission-related tasks and may be responsible for mentoring other Regulatory Operations team members.

Responsibilities and Job Duties

  • Responsible for the preparation, dispatch, tracking and archiving of electronic submissions for developing and marketing applications.
  • Represents the Regulatory Operations function in project team meetings to facilitate and assist with meeting submission timelines. When timelines are jeopardized, makes recommendations for modifications and or solutions.
  • Develops and provides training on Regulatory Operations software tools and publishing concepts to junior Regulatory Operations personnel and other internal stakeholders
  • Develops, revises and maintains best practices for Regulatory Operations department to ensure compliance with changing FDA/ICH regulations. Educates internal team and stakeholders on importance and relevance to ensure compliance.
  • Effectively manages and interacts with internal stakeholders, vendors and corporate partners as they pertain to the development, management and validation of Regulatory Operations projects.
  • Interacts with Regulatory Agencies as needed to gain clarity/guidance on Regulatory Operations topics. Communicates information with appropriate team members and/or stakeholders.
  • Provides input/recommendation to project teams and/or Senior Management on electronic submissions strategies to support BLA/NDA and IND applications.
  • Leads software implementation and validation projects for Regulatory Operations. Ensures that the right stakeholders and internal team members are involved at the appropriate times.
  • Guides and mentors junior Regulatory Operations personnel on submission preparation and compilation to ensure consistency with submission standards and quality of content , as well as how to work effectively with document stakeholders and manage multiple priorities.
  • Provides training and education to junior Regulatory Operations staff and key stakeholders of new electronic submissions/eCTD guidelines and initiatives
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