Global Regulatory Lead, Precision Medicine & Digital Health
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Job summary
Takeda is seeking a senior regulatory professional to lead global regulatory strategies for precision medicine and digital health across programs. You will partner with cross-functional teams to align regulatory plans and drive submissions to major health authorities remotely from the US.
The role requires strong experience in devices/diagnostics, strategic communication, and a track record of influencing global regulatory decisions.
Qualifications
- Bachelor's Degree in a scientific discipline.
- Advanced degree (PhD/MD/PharmD/MS) strongly preferred.
- Minimum 5 years of regulatory affairs experience with devices/diagnostics within the pharmaceutical industry preferred.
- Proven track record in digital health/diagnostics and precision medicine regulatory strategies.
Responsibilities
- Develop and lead global regulatory strategies for precision medicine and digital health.
- Identify regulatory requirements and provide guidance to global development teams.
- Partner with regional regulatory representatives to manage lifecycle regulatory activities across markets.
- Represent the Global Regulatory Affairs function in senior governance and health authority meetings.
- Provide training to cross-functional teams on regulatory requirements and processes.
Skills
Education
Job description
Takeda is seeking a senior regulatory professional to lead global regulatory strategies for precision medicine and digital health across programs. You will partner with cross-functional teams to align regulatory plans and drive submissions to major health authorities remotely from the US.
The role requires strong experience in devices/diagnostics, strategic communication, and a track record of influencing global regulatory decisions.
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