Takeda · 9 hours ago
Regulatory Compliance, Senior Manager
Boston, MA
Full-time
Hybrid
Senior Level, Lead/Staff, Director/Executive
$137K/yr - $215K/yr
6+ years expTakeda is dedicated to bringing forward new plasma-derived therapies for patients with complex diseases. The Regulatory Compliance, Senior Manager will ensure regulatory approval for new products, maintain compliance, and prepare necessary documentation to support the organization's mission.
BiotechnologyHealth CareManufacturingMedicalPharmaceutical
Responsibilities
Ensure the organization is aware of and compliant with legislation and regulations pertaining to the business
Monitor and interpret regulatory developments, determining the impact on business operations and compliance programs
Implement compliance measures and ensure adherence to regulatory standards
Prepare, review, and approve regulatory compliance documents for internal and external audiences
Manage large projects or processes with limited oversight from the manager
Coach, review, and delegate work to lower-level professionals
Serve as a consultant to management and an external spokesperson on major matters
Qualification
Required
BSc degree, preferred; BA accepted
6+ years of pharmaceutical industry experience. This is inclusive of 4 years of regulatory compliance or combination of 4+ years regulatory and/or related experience
Proficient in regulatory compliance, capable of advising others and handling highly complex compliance issues independently
Advanced proficiency in toxicology, capable of handling complex cases and offering guidance to others based on a deep understanding of chemical interactions with organisms
Performs advanced Environment Health and Safety tasks independently, capable of coaching others and making improvement recommendations
Leads new product development projects, advising on market analysis and customer needs, capable of managing complex situations and guiding others
Capable of independently managing and improving organizational structures and processes, can coach others in effective organization
Leads project management efforts in complex situations, advising and coaching others, and contributing to process improvements
Advanced writing ability, capable of crafting well-structured content for a variety of complex scenarios and can mentor others in improving their writing skills
Fully capable of executing complex risk analysis independently, advising on mitigation strategies, and coaching others in risk analysis methods and principles
Fully capable of managing time in highly complex situations and can coach others on time management techniques and improvements
Excellently manages tasks requiring high attention to detail, independently addresses complex scenarios, and advises others on maintaining precision
Skilled in creating and delivering persuasive and impactful presentations in a variety of complex situations, able to mentor others in developing their presentation skills
Advanced in auditing, capable of handling highly complex situations, making improvement recommendations, and coaching others
As an expert professional within the organization, you develop innovative solutions to complex problems aligned with organizational objectives. Your work involves addressing intricate issues, requiring in-depth analysis and judgment
Preferred
Advanced scientific degree (MSc, PhD, or PharmD) preferred
Benefits
Medical, dental, vision insurance
A 401(k) plan and company match
Short-term and long-term disability coverage
Basic life insurance
A 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
2026-01-25
legacy.thefly.com
2026-01-23
2026-01-22
Company data provided by crunchbase