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Job Description

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 Executive Director Global Regulatory Affairs CMC Devices and Drug-Device Combination Product you will provide strategic leadership and development to global regulatory subject matter experts to ensure innovative and robust regulatory strategies for medical devices and drug-device combination products maximizing global regulatory success and minimizing time to approval/clearance.

Establish best practices and builds a strong regulatory community across Global Regulatory Affairs spanning device combination product quality clinical development and manufacturing interfaces.

Serve as an influential leader internally and externally shaping regulatory policy and cross-functional decision-making for devices and combination products across major regions (e.g. US EU UK Japan China).

How you will contribute:

• Leads and develops a team of regulatory leaders and subject matter experts overseeing global regulatory strategy and major submissions for an assigned portfolio of medical devices and drug-device combination products ensuring clear strategy high-quality execution and timely approvals/clearances.

• Partners with cross-functional leaders (Regulatory Development Clinical Quality Safety Manufacturing Supply Chain Market Access and Medical) to align evidence generation usability/human factors risk management and value messaging to regulatory and access requirements for devices and combination products.

• Ensures line management and key stakeholders are apprised of developments impacting regulatory success (e.g. design changes nonconformances clinical evidence labeling/UDI post-market signals). Anticipates risks and drives mitigation plans consistent with ISO 14971 design controls and applicable global regulations.

• Represents Global Regulatory Affairs in senior-level governance and in interactions with global regulators and notified bodies including FDA (CDRH/CDER and Office of Combination Products) EMA/Competent Authorities under EU MDR MHRA PMDA and other agencies as applicable.

• Accountable for ensuring global submissions and lifecycle compliance for devices and combination products (e.g. IDE 510(k) De Novo PMA CE marking under MDR technical documentation variations/changes vigilance). Partners with regional leads quality and vendors to ensure compliant inspection-ready processes and documentation.

• Leads departmental and cross-functional initiatives to improve regulatory strategy operational excellence and quality systems interfaces (e.g. design controls labeling governance supplier controls post-market surveillance digital/connected device considerations). Influences without authority across R&D and Global Regulatory Affairs.

• Provides regulatory strategy leadership for business development and due diligence activities including assessment of device/combination product classification regulatory pathways technical evidence requirements and lifecycle obligations.

• Monitors and anticipates global regulatory trends impacting devices and combination products (e.g. MDR implementation FDA guidance standards such as ISO 13485/14971/IEC 62304 cybersecurity expectations) translating insights into proactive regulatory and evidence strategies.

• Responsible for demonstrating Takeda leadership behaviors.

Minimum Requirements/Qualifications:

• Advanced degree in a scientific or engineering discipline (e.g. MS PhD PharmD)

• 20 years of industry experience with 10 years in Regulatory Affairs and demonstrated leadership in medical devices and/or drug-device combination products.

• Significant experience leading reviewing authoring or managing regulatory submissions for devices and/or combination products (e.g. IDE 510(k) De Novo PMA CE marking/MDR technical documentation) including major deficiency responses and negotiation of requirements.

• Strong working knowledge of device and combination product development and regulatory requirements including FDA (CDRH/CDER/OCP) EU MDR/IVDR and post-market/vigilance obligations; experience with other regions a plus.

• Understands and interprets complex technical nonclinical clinical and manufacturing issues across multiple programs as they relate to device/combination regulatory requirements and strategy.

• Provides expert guidance on global device/combination regulatory strategy including technical documentation/Design History File expectations design controls human factors/usability biocompatibility software and cybersecurity considerations (as applicable) and post-market lifecycle planning.

• 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 innovative

• Solutions and strategies including risk mitigation strategies.

• Must work well with others and within global teams.

• Able to bring working teams together for common objectives.

• Acceptable and independent skills 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.

More about us:

At Takeda we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer Takeda offers stimulating careers encourages innovation and strives for excellence in everything we do. We foster an inclusive collaborative workplace in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This position is currently classified as hybrid following Takedas Hybrid and Remote Work policy.

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Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees and we strive to be more transparent with our pay practices.

For Location:

U.S. Base Salary Range:

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors including the qualifications of the individual applicant for the position years of relevant experience specific and unique skills level of education attained certifications or other professional licenses held and the location in which the applicant lives and/or from which they will be performing the actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical dental vision insurance a 401(k) plan and company match short-term and long-term disability coverage basic life insurance a tuition reimbursement program paid volunteer time off company holidays and well-being benefits among others. U.S. based employees are also eligible to receive per calendar year up to 80 hours of sick time and new hires are eligible to accrue up to 120 hours of paid vacation.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race color religion sex sexual orientation gender identity gender expression parental status national origin age disability citizenship status genetic information or characteristics marital status status as a Vietnam era veteran special disabled veteran or other protected veteran in accordance with applicable federal state and local laws and any other characteristic protected by law.

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Job Exempt