Associate Director, Device and Drug-Device Combinations EU and Global Markets

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Client:

Takeda

Location:

Job Category:

Other

Job Reference:

241965609847

Job Views:

2

Posted:

17.04.2025

Expiry Date:

01.06.2025

Job Description:

Description

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 three therapeutic areas and other targeted investments, we push the boundaries of what is possible to bring life-changing therapies to patients worldwide.

How you will contribute:

OBJECTIVES:

• Responsible for the development and implementation of innovative integral combination product regulatory strategies pertaining to the development, registration, commercialization and life cycle management of assigned asset programs in EU and Global Markets.
• For EU and Global Markets, utilizes technical knowledge, regulatory expertise and global regulatory lessons learned to shape global regulatory best practices, drive internal consistency and influence effective change management.
• Builds and manages strong working relationships through active partnering with key internal and external stakeholders.

ACCOUNTABILITIES:

• Responsible for demonstrating Takeda leadership behaviors.
• Serves as Drug-Device Combinations EU & Global Markets lead for assigned asset programs.
• In consultation with regulatory Foundational Subject Matter Expert/Platform Leads (e.g., Design Control, Human Factors, etc.), reviews design control documentation to assure alignment with regulatory requirements and standards.
• Provides program-level tactical regulatory guidance to product teams in line with EU & Global Markets regulatory strategies.
• Proactively identifies combination product and device-related regulatory risks, ensuring timely communication with line management.
• Supports and/or leads assigned drug-device combination aspects of EU & Global Markets regulatory submissions.
• Provides EU & Global Markets regulatory input and support on product-compliance related activities.
• Works effectively across a complex matrix environment in GRA with GRLs, GRA CMC project leads and other GRA sub-functions.
• Develops and maintains constructive relations with key internal and external colleagues.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• BS/BA Degree in a Scientific, Pharmaceutical or Engineering Discipline.
• 8+ years of pharmaceutical Regulatory CMC and Medical Device experience.
• Experience working on cross-functional submission teams.
• Solid understanding and proven ability to provide strategy on regulatory requirements relevant to global drug-device combination product development.
• Experience supporting interactions with EMA, Notified Bodies and other global health authorities is strongly preferred.
• Demonstrates emerging leadership, problem-solving ability, flexibility and teamwork.
• Excellent written and oral communication skills are required.
• Able to deal with issues of critical importance and make reasoned decisions on regulatory issues.

TRAVEL REQUIREMENTS:

• Willingness to travel to various meetings or events, including overnight trips. Some international travel may be required.