Manager, Global Regulatory Lead, GI & Inflammation

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Job Description

Objective / Purpose:

• Contributes to global regulatory team to develop strategies to maximize regulatory success towards achievement of program objectives.
• Provides strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements.
• May communicate with FDA as required.

Accountabilities:

• The Manager role includes managing one or more projects with less complexity. May support GRL on more complex programs. May lead working groups, and represents Global Regulatory Team (GRT) at project team meetings. Provides strategic and tactical guidance to teams, including regulatory review of clinical trial documents and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance.
• Ensure or assist in ensuring that regulatory strategies defined within the GRT are effectively implemented and maintained in line with changing regulatory and business needs.
• Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.
• Contributes to Health Authority submissions and approvals for project(s) within scope.  The Manager may lead less complex multi-function submissions, such as original INDs or support GRLs for more complex submissions, including major global marketing applications.
• Assists and attends FDA and other agency meetings.
• Accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and to maintain compliance for products.
• Attends study team meetings and provides regulatory guidance.
• Oversee vendor responsibility for regulatory activities and submissions related to projects within scope.
• May participate on departmental task-forces or initiatives.
• Partner with functions responsible for ensuring market access and regional GRA leads to understand market access topics and strategize opportunities to strengthen product development plan(s) and build into global integrated regulatory strategy.

Education & Competencies (Technical and Behavioral):

• Bachelor’s Degree required, scientific discipline strongly preferred, advanced degree in a scientific discipline preferred.
• A minimum of 2 years of pharmaceutical industry experience.  This is inclusive of 1 year of regulatory experience or combination of 2 year regulatory and/or related experience. 
• Preferred experience in reviewing, authoring, or managing components of regulatory submissions. 
• Basic working knowledge of drug development process and regulatory requirements.
• Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects.
• Demonstrates acceptable skills in oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
• Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
• Must work well with others and within global teams. 
• Able to bring working