Associate Director, Global Regulatory Affairs Marketed Products

Job Description

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About the role :

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients.

By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

As an Associate Director, Global Regulatory Affairs Marketed Products you will define, develop and lead global strategies to maximize global regulatory success towards achievement of program objectives for complex and / or multiple projects.

You will provide strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements.

You will be a leader within Takeda and external to Takeda, contributing to cross-functional initiatives and influencing the field as applicable.

How you will contribute :

The Associate Director will be responsible for increasingly complex or multiple projects. Leads the Global Regulatory Team (GRT) and applicable sub-working groups, such as the Label Working Group, and represents GRT at project team meetings.

Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance and / or oversees direct reports or junior staff responsible.

• 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.
• Proactively anticipates risks and responsible for developing solutions to identified risks and discussing with team and management;

understands probabilities of technical success for the solutions.

Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports or junior colleagues executing these tasks.

The Associate Director will lead highly complex submission types such as original NDA / BLAs.

• Direct point of contact with FDA, leads and manages FDA meetings. Manages direct reports or junior staff as needed.
• 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.
• Oversee vendor responsibility for regulatory activities and submissions related to projects within scope.
• Participates with influence in departmental and cross-functional task-forces and initiatives.
• Lead regulatory reviewer in due diligence for licensing opportunities.
• Partner with global market access colleagues to lead interactions with joint regulatory / health agency / HTA bodies on product specific value evidence topics, as applicable.
• Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner.
• Responsible for demonstrating Takeda leadership behaviors.

Minimum Requirements / Qualifications :

• BSc Degree, preferred. BA accepted.
• 8+ years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or combination of 5+ years regulatory and / or related experience.
• Preferred experience in reviewing, authoring, or managing components of regulatory submissions.
• Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus.
• Understand and interpret complex scientific issues across multiple projects as it related to regulatory requirements and strategy.
• Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy.
• Strong 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.

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