Takeda · 1 day ago
Senior Director, Global Regulatory Lead – Oncology
Boston, MA
Full-time
Hybrid
Director/Executive
$208K/yr - $327K/yr
12+ years expTakeda is a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. As a Senior Director, Global Regulatory Lead – Oncology, you will lead a top-priority program, building cross-functional teams to develop actionable regulatory strategies for high-impact oncology programs.
BiotechnologyHealth CareManufacturingMedicalPharmaceutical
Hiring Manager
Anula Aboobacker
Responsibilities
Lead global regulatory strategy for assigned programs across development stages. Provide strategic, operational and tactical regulatory insight on one or multiple complex global oncology projects in clinical development with focus on innovative ways of addressing barriers to development strategies as well as accelerating access of our products to patients
Will be responsible for complex and potentially multiple projects within the Oncology TAU. Interfaces with the Global Project Team (GPT) to lead and support cross-functional company objectives
Serve as global regulatory lead (GRL)/ Franchise global regulatory lead (GRL) on cross-functional teams for priority programs, providing strategic input and regulatory expertise
Leads the Global Regulatory Teams (GRT) accountable for the development of innovative global strategies in line with applicable regulations to achieve business objectives for development of Oncology products. When necessary, seeks expert advice and technical support from functional stakeholders and senior management
Acts independently under the direction of a Global Regulatory Portfolio Lead and/or TA Head. May participate in or lead regulatory and company initiatives. Based on experience and scientific strengths, expands knowledge of TA and provides coaching and mentoring for GRT members
Ensures alignment of global regulatory strategies with Leadership Team. Presents meaningful regulatory assessments and regulatory recommendations to management
Ensure project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercise sound judgement and communicating in a professional and timely manner
Accountable for US FDA submissions and approvals of project(s) of responsibility. May serve as the primary FDA point of contact for projects of responsibility
Accountable for independently ensuring all submission types are executed on time with high quality, including major submissions (NDA/BLA/MAA)
For the project(s) of responsibility, collaborate with all Takeda regions to ensure a global regulatory strategy is created and executed upon for all projects within area of responsibility
Partner with global market access colleagues to lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable
Develop/author and execute global regulatory strategies for complex strategies. May oversee execution
Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner
Responsible for demonstrating Takeda leadership behaviors
May lead regulatory assessment as part of due diligence teams for licensing opportunities
Identify and propose solutions to management for any resource gaps for assigned project(s)
Qualification
Required
BSc/BA Degree, scientific discipline strongly preferred
Advanced degree in a scientific discipline (PharmD/PhD/MD) strongly preferred
12+ years of pharmaceutical industry experience. This is inclusive of 10 years of regulatory experience or combination of 8+ years regulatory and/or related experience
Experience in reviewing, authoring, or managing components of regulatory submissions including for Late-Stage assets
Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus
Understand and interpret complex scientific issues across multiple projects as it related to regulatory requirements and strategy
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 regulatory strategy
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
Strong and independent skills in 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
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
Benefits
Short-term and/ or long-term incentives
Medical, dental, vision insurance
401(k) plan and company match
Short-term and long-term disability coverage
Basic life insurance
Tuition reimbursement program
Paid volunteer time off
Company holidays
Well-being benefits
Up to 80 hours of sick time
Up to 120 hours of paid vacation
Company
Takeda
Takeda is a biopharmaceutical company that researches and develops pharmaceutical drugs.
10001+ employees
H1B Sponsorship
Takeda has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (45)
2024 (39)
2023 (38)
2022 (34)
2021 (44)
2020 (18)
Funding
Current Stage
Public CompanyTotal Funding
$2.46B2025-06-27Post Ipo Debt· $2.4B
2016-09-01Grant· $19.8M
2016-05-08Grant· $38M
Leadership Team
Christophe Weber
President and CEO
Schuyler Fairfield
Senior Vice President, Global Head of Supply Chain
Recent News
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