BioSpace
Senior Director, Global Regulatory Lead – Oncology
BioSpace, Boston, Massachusetts, us, 02298
Senior Director, Global Regulatory Lead – Oncology
Join Takeda as a Senior Director, Global Regulatory Lead – Oncology, leading global regulatory strategy for transformative oncology programs, from development through registration and launch readiness.
Responsibilities
Lead global regulatory strategy for assigned programs across development stages, providing strategic, operational, and tactical regulatory insight.
Serve as global regulatory lead (GRL) on cross-functional teams for priority programs, providing regulatory expertise.
Lead the Global Regulatory Teams (GRT) accountable for innovative global strategies in line with applicable regulations.
Ensure alignment of global regulatory strategies with Leadership Team and present regulatory assessments and recommendations to management.
Accountable for US FDA submissions and approvals, ensuring timely, high-quality submission execution.
Collaborate with all Takeda regions to ensure a global regulatory strategy is created and executed.
Partner with global market access colleagues to lead interactions with joint regulatory/health agency/HTA bodies on product-specific value evidence topics.
Develop and execute global regulatory strategies for complex projects, overseeing execution and monitoring trends impacting regulatory and access environments.
Identify and propose solutions to management for any resource gaps for assigned projects.
Minimum Requirements/Qualifications
BSc/BA degree in a scientific discipline; advanced degree (PharmD/PhD/MD) strongly preferred.
12+ years of pharmaceutical industry experience, including 10 years of regulatory experience.
Experience reviewing, authoring, or managing components of regulatory submissions for late-stage assets.
Solid working knowledge of drug development process and regulatory requirements (FDA, EU, Canada, ROW, post‑marketing).
Strong oral and written communication, negotiation, integrity, and adaptability.
Ability to work well within global teams and bring teams together for common objectives.
Benefits & Compensation Position classified as “hybrid” following Takeda's Hybrid and Remote Work policy. U.S. base salary range: $208,200 – $327,140. Eligible for short‑term and long‑term incentives, medical, dental, vision, 401(k) with company match, disability, life, tuition reimbursement, paid volunteer time, holidays, well‑being benefits, sick time, paid vacation.
Location: Boston, MA.
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.
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Responsibilities
Lead global regulatory strategy for assigned programs across development stages, providing strategic, operational, and tactical regulatory insight.
Serve as global regulatory lead (GRL) on cross-functional teams for priority programs, providing regulatory expertise.
Lead the Global Regulatory Teams (GRT) accountable for innovative global strategies in line with applicable regulations.
Ensure alignment of global regulatory strategies with Leadership Team and present regulatory assessments and recommendations to management.
Accountable for US FDA submissions and approvals, ensuring timely, high-quality submission execution.
Collaborate with all Takeda regions to ensure a global regulatory strategy is created and executed.
Partner with global market access colleagues to lead interactions with joint regulatory/health agency/HTA bodies on product-specific value evidence topics.
Develop and execute global regulatory strategies for complex projects, overseeing execution and monitoring trends impacting regulatory and access environments.
Identify and propose solutions to management for any resource gaps for assigned projects.
Minimum Requirements/Qualifications
BSc/BA degree in a scientific discipline; advanced degree (PharmD/PhD/MD) strongly preferred.
12+ years of pharmaceutical industry experience, including 10 years of regulatory experience.
Experience reviewing, authoring, or managing components of regulatory submissions for late-stage assets.
Solid working knowledge of drug development process and regulatory requirements (FDA, EU, Canada, ROW, post‑marketing).
Strong oral and written communication, negotiation, integrity, and adaptability.
Ability to work well within global teams and bring teams together for common objectives.
Benefits & Compensation Position classified as “hybrid” following Takeda's Hybrid and Remote Work policy. U.S. base salary range: $208,200 – $327,140. Eligible for short‑term and long‑term incentives, medical, dental, vision, 401(k) with company match, disability, life, tuition reimbursement, paid volunteer time, holidays, well‑being benefits, sick time, paid vacation.
Location: Boston, MA.
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.
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