Global Regulatory Lead: Precision Medicine & Digital Health

Takeda; United States; Remote; USD 154,000 - 243,000; Full time

Job summary

Takeda is seeking a Regulatory Affairs professional to provide strategic guidance for global regulatory strategies in precision medicine and digital health across multiple programs. You will coordinate with local/regional teams, ensure compliance, and guide submissions to health authorities.

The role requires experience with device/diagnostic submissions and strong communication with FDA/EMA, with a focus on innovation in regulatory approaches.

Qualifications

• Bachelor’s Degree, scientific discipline strongly preferred.
• Advanced degree in a scientific discipline (PhD., M.D., PharmD, MS) strongly preferred.
• A minimum of 5 years of experience in regulatory affairs. Experience working with medical devices and/or diagnostics within the pharmaceutical industry strongly preferred.
• Proven track record in developing and managing regulatory strategies for digital health products, and/or diagnostics, and precision medicine.
• Expert knowledge of device development, registration and maintenance requirements with experience in championing innovation in technical areas.
• Comprehensive understanding of biomarker strategies and implications for drug development.
• Demonstrated track record of successful interactions with FDA, EMA, Notified Bodies, and other global health authorities specifically related to Device submissions (i.e., IND, SRDs, IDEs, CTA, IMPD, BLA, MAA, NDA, 510K, CE Mark submissions and their amendments/supplements).
• Understanding of scientific principles and device regulatory requirements relevant to global drug development and post-market support, including EU MDR and IVDR.
• 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 global regulatory strategy.
• Demonstrates strong verbal and written communication skills, with the ability to translate complex regulatory concepts into clear, stakeholder-tailored communication

Responsibilities

• Develops and leads the global regulatory strategies for precision medicine and digital health efforts for assigned programs.
• Identifies regulatory requirements and provides regulatory guidance to global development teams.
• Leads lifecycle management regulatory activities for the digital health and precision medicine portfolio across markets.
• Integrates drug and diagnostic regulatory plans, including HA engagement plans and mitigation strategies.
• Maintains communication with stakeholders on regulatory developments and risks.
• Represents GRA in senior-level interactions at governance committees and health authority meetings.
• Contributes to cross-functional task-forces and initiatives.
• Provides regulatory training to cross-functional teams.
• Supports diligence for licensing opportunities and regulatory input on partner selections.

Skills

Regulatory strategy

Digital health

Biomarkers

FDA interactions

Global regulatory affairs

Education

Bachelor’s Degree

Advanced degree

Job description

Takeda is seeking a Regulatory Affairs professional to provide strategic guidance for global regulatory strategies in precision medicine and digital health across multiple programs. You will coordinate with local/regional teams, ensure compliance, and guide submissions to health authorities.

The role requires experience with device/diagnostic submissions and strong communication with FDA/EMA, with a focus on innovation in regulatory approaches.