Takeda · 18 hours ago
Senior Director, Global Regulatory Lead, GI & Inflammation
Boston, MA
Full-time
Onsite
Director/Executive
$208K/yr - $327K/yr
12+ years expTakeda is a global biopharmaceutical company, and they are seeking a Senior Director, Global Regulatory Lead for GI & Inflammation. This role involves defining and leading global regulatory strategies for complex projects, providing strategic advice, and ensuring compliance with regulatory requirements while leading cross-functional teams.
BiotechnologyHealth CareManufacturingMedicalPharmaceutical
Responsibilities
Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects
Provides strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements
Is a leader both in the department and within R&D, leading and/or contributing with influence to cross-functional initiatives and influencing the field as applicable
Provides leadership and development for other global regulatory leads responsible for the design and execution of global regulatory strategies in collaboration with their regional counterparts
The Senior Director will be responsible for complex or highly complex or multiple projects
Leads the Global Regulatory Teams (GRTs) and applicable sub-working groups, such as the Label Working Group, and represents GRTs at project team meetings
Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance
Ensures global regulatory strategies defined within the GRT are effectively implemented and maintained in line with changing regulatory and business needs and anticipates such changes to lead adaptations to regulatory strategy
Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner
Proactively anticipates risks and responsible for developing solutions to identified risks and discussing with team and management; understands probabilities of technical success for the solutions
Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports or other staff responsible
The Senior Director will lead all submission types
Direct point of contact with health authorities, leads and manages FDA meetings and/or other regional HA meetings as appropriate
Manages direct reports or junior staff as needed
Accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and to maintain compliance for products
Oversee vendor responsibility for regulatory activities and submissions related to projects within scope
Participates with influence in or leads departmental and cross-functional task-forces and initiatives
Lead regulatory reviewer in due diligence for licensing opportunities
Partner with global market access colleagues to lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable
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
Qualification
Required
Bachelor's Degree, scientific discipline 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
Expert 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
Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability
Demonstrates strong skills with increasing independence 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
Must work well with others and within global teams
Able to bring working teams together for common objectives
Preferred
Advanced degree in a scientific discipline (PharmD/PhD/MD) strongly preferred
Benefits
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
2026-01-09
2026-01-08
Company data provided by crunchbase