Director Global Regulatory Affairs - Precision Medicine and Digital Health
Location: Remote
Job Level: Senior
Travel: Minimal (if any)
Worker Type: Employee
Worker Sub-Type: Regular
Time Type: Full time
Job Exempt: Yes
At Takeda, a global leader in breakthrough medicines, we are looking for a strategic leader to guide and oversee the development of global regulatory strategies for precision medicine, diagnostic tests, devices, and digital health tools. This position will play a pivotal role in driving product value across therapeutic areas by collaborating with cross-functional teams and ensuring alignment with regulatory requirements.
Position Objectives:
Lead global regulatory strategies to support the development and commercialization of biomarkers, diagnostic tests, and digital health tools.
Work closely with various teams to ensure the goals of precision medicine and digital health efforts are met.
Provide strategic guidance to drive the integration of drug and diagnostic regulatory plans.
Key Responsibilities:
Oversee precision medicine and digital health efforts for assigned programs, ensuring regulatory plans align with product development.
Manage global regulatory strategies, including the integration of drug and diagnostic regulatory submission plans and health authority engagement.
Provide regulatory oversight and guidance to teams, ensuring they meet development and submission objectives while mitigating risks.
Represent the Global Regulatory Affairs (GRA) function in senior-level interactions with technical review committees and health authorities.
Lead departmental and cross-functional initiatives, influencing non-direct reports and stakeholders across the enterprise.
Monitor emerging regulatory trends to adapt strategies and strengthen product development.
Requirements:
PhD, M.D., PharmD, or MS with a solid scientific background.
A minimum of 8 years of pharmaceutical industry experience, including at least 6 years in regulatory affairs.
Expertise in device development, biomarker strategies, and regulatory processes such as IND, SRD, CTA, BLA, MAA, NDA, 510K, and CE Mark submissions.
Excellent communication, negotiation, and interpersonal skills to work across regulatory and industry boundaries.
Proven track record of successful interactions with FDA, EMA, Notified Bodies, and other global health authorities.
Preferred Experience:
Experience with reviewing, authoring, or managing drug and device regulatory submissions.
Strong knowledge of the EU MDR and IVDR, along with scientific data interpretation to guide regulatory strategy.
Base Salary Range for U.S. (Virtual - Massachusetts):
$169,400.00 - $266,200.00 (The final salary will depend on experience and other factors.)
Short-term and long-term incentives may apply.
U.S. employees are eligible for medical, dental, vision insurance, a 401(k) plan, paid time off, and other benefits.
Takeda is committed to fostering a diverse workforce and providing equal employment opportunities to all applicants, regardless of race, color, religion, sex, sexual orientation, gender identity, disability, or other protected categories under the law.
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