Takeda · 3 days ago
Associate Director, Global Regulatory Affairs - GI & Inflammation
Boston, MA
Full-time
Hybrid
Senior Level, Lead/Staff, Director/Executive
$154K/yr - $241K/yr
6+ years expTakeda is a leading global biopharmaceutical company, and they are seeking an Associate Director for Global Regulatory Affairs in GI & Inflammation. This role involves defining and leading global regulatory strategies, ensuring compliance with regulatory requirements, and providing leadership to 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, contributing to cross-functional initiatives and influencing the field as applicable
Provides leadership and development for direct reports, including those that serve as global regulatory leads responsible for the design and execution of global regulatory strategies in collaboration with their regional counterparts
The Associate 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 and/or oversees direct reports or junior staff responsible
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 responsible
The Director will lead all submission types
Accountable for building global regulatory strategies as defined within the GRT and ensure those are effectively implemented and maintained in line with changing regulatory and business needs
Direct point of contact with health authorities, leads and manages FDA meetings
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
Advanced degree in a scientific discipline (PharmD/PhD/MD) strongly preferred
6+ years of pharmaceutical industry experience. This is inclusive of 4+ years of regulatory experience
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 relates 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 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
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
Preferred
Preferred experience in reviewing, authoring, or managing components of regulatory submissions
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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