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Manager Regulatory Operations

Company: Shepherd Regulatory Search
Location: Dayton
Posted on: January 15, 2022

Job Description:

Shepherd Regulatory Search has been engaged for a newly created Manager, Regulatory Operations position. In this role, you will be responsible for leading consulting projects focused on process improvements or technology implementations in the Regulatory Affairs function.
Organization: Our client is one of the world's premier consulting firms, with a wealth of learning and career development opportunities, a world-class training facility, and leading market tools. They foster a team-driven culture ensuring continued growth both professionally and personally, with offices strategically located throughout the country.
Position: The Manager Regulatory Operations is responsible for developing, coordinating, and implementing oversight of client engagements throughout the project lifecycle, ensuring timely execution of deliverables.
Responsibilities:

  • Lead consulting projects for Life Sciences clients focused on process improvements or technology implementations in the Regulatory Affairs function.
  • Provide oversight of client work teams throughout the project lifecycle and help ensure timely execution of project deliverables.
  • Lead client interactions with Regulatory Information Management (RIM) or Document Management systems.
  • Facilitate engagement decisions, including work plan and timeline, project management, resource allocation, and career development of team members.
  • Structure and perform analysis on regulatory-related processes, data, business requirements, operating models, IT systems.
  • Manage projects related to process transformation, operational improvements, and organizational redesign.
  • Oversee projects related to system implementations and or digital solutions.
    Requirements:
    • Must have experience with Regulatory Information Management (RIM) or Document Management systems.
    • Experience serving on an implementation team for a RIM or Document Management system.
    • Minimum of five years of work experience related to the Regulatory Affairs function within the pharmaceutical and or medical device industry.
    • Bachelor's degree in an appropriate field from an accredited college/university; Master's degree from an accredited college/university preferred.
    • Experience with operational process improvement initiatives in the pharmaceutical and or medical device industry.
    • Prior professional services or consulting experience preferred.
    • Strong understanding of Regulatory Affairs related data and documents.

Keywords: Shepherd Regulatory Search, Trenton , Manager Regulatory Operations, Executive , Dayton, New Jersey

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