Title: Director, Global Regulatory Lead - Oncology Location: USA - MA - Boston Full time Job Description: About the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Takeda is committed to creating better health for people and a brighter future for the world. Guided by our OneOncology vision, we are advancing a rapidly growing oncology portfolio with potentially first-in-class and best-in-class therapies, including ADCs, complex biologics and small molecules. Our goal is to accelerate access to transformative medicines and make a lasting impact on patients worldwide. Join Takeda as a Director, Global Regulatory Lead Oncology where you will be part of the global regulatory team. As Director, Global Regulatory Lead Oncology you will set global regulatory strategy and lead major submissions for high-impact oncology programs. How you will contribute: - Oversee as well as execute all regulatory activities of one or multiple complex projects in development and/or supports regulatory activities for assigned projects. - Serve as global regulatory lead (GRL) on the global project team (GPT) for individual project(s) of responsibility. - May lead the global regulatory sub-team (GRT) for assigned projects. - May serve as global and/or regional regulatory lead as a member of a GRT - Primary FDA contact for projects of responsibility. - Accountable for all US FDA submissions and approvals of project(s) 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. - Ensure 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. - Participate with influence in or leads departmental and cross-functional task-forces and initiatives. - May 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). - May present to senior management as requested. - Participate with influence in or leads departmental and cross-functional task-forces and initiatives. Minimum Requirements/Qualifications: - Bachelor’s Degree required, scientific discipline strongly preferred, advanced degree in a scientific discipline strongly preferred. - A minimum of 8 years of pharmaceutical industry experience, inclusive of regulatory and/or related experience. - Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA is a must. Knowledge of EU, Canada, ROW is a plus. - Experience in managing major regulatory filing(s); and experience as a significant contributor to regulatory and/or development strategies - Understand and interpret complex scientific issues across multiple projects as it relates to regulatory requirements and strategy. - Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. - Demonstrate strong skills with increasing independence in the area of regulatory strategy. - Strong ability to work well with others and within global teams; and acceptable at communicating with senior leadership. - 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. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. This position is currently classified as "hybrid" following Takeda's Hybrid and Remote Work policy. #LI-Hybrid #LI-AA1 Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $177,000.00 - $278,080.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in 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, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. 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, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes

Title: Analyst, Forensics and Compliance - Disputes, Claims & Investigations Location: Washington, DC Job Description: At Stout, we’re dedicated to exceeding expectations in all we do – we call it Relentless Excellence ®. Both our client service and culture are second to none, stemming from our firmwide embrace of our core values: Positive and Team-Oriented, Accountable, Committed, Relationship-Focused, Super-Responsive, and being Great communicators. Sound like a place you can grow and succeed? Read on to learn more about an exciting opportunity to join our team. As an Analyst within Forensics & Compliance practice, you will support client engagements involving forensic accounting, compliance reviews, and complex financial investigations. Working closely with senior team members, you will help analyze financial information, organize data, and prepare client-ready work product in high stakes environments. What You’ll Do: - Assist with day-to-day engagement tasks under the guidance of senior team members - Support technical accounting and financial analyses involving U.S. GAAP, IFRS, and SEC regulations - Organize, validate, and analyze financial data, documents, and supporting materials - Assist with profit and gain calculations, inability-to-pay analyses, and other financial assessments - Review transactions and internal control documentation to support investigative work - Help identify patterns, anomalies, and potential accounting irregularities - Maintain documentation of procedures, assumptions, data sources, and findings - Draft sections of reports, memoranda, presentations, and client-facing deliverables - Collaborate with internal teams, legal counsel, and third-party professionals as needed - Participate in training, coaching, and professional development opportunities Qualifications/Requirements: - Bachelor’s or master’s degree in accounting or related field - 0-2 years of relevant experience in accounting, audit, forensic accounting, compliance, or litigation support (post-grad experience preferred) - CPA eligibility preferred - Foundational knowledge of U.S. GAAP, familiarity with IFRS and SEC regulations a plus - Strong analytical, research, and problem-solving skills - Proficiency in Microsoft Excel, Word, and PowerPoint - Familiarity with Access, Alteryx, SQL, or Power BI a plus - Strong written and verbal communication skills with high attention to detail - Ability to work in a hybrid environment including client site time in Washington D.C. - U.S. Citizenship and ability to pass a Federal Government background investigation preferred How You’ll Thrive: - Bring curiosity and initiative to complex financial and investigative matters - Communication clearly and professionally with team members and stakeholders - Ask thoughtful questions and seek feedback to strengthen your technical skills - Adapt to changing priorities and deadlines in dynamic engagement environments - Manage tasks carefully while maintaining accuracy and attention to detail - Deliver Relentless Excellence® through quality work, collaboration, and continuous learning Why Stout? At Stout, we offer a comprehensive Total Rewards program with competitive compensation, benefits, and wellness options tailored to support employees at every stage of life. We foster a culture of inclusion and respect, embracing diverse perspectives and experiences to drive innovation and success. Our leadership is committed to inclusion and belonging across the organization and in the communities we serve. We invest in professional growth through ongoing training, mentorship, employee resource groups, and clear performance feedback, ensuring our employees are supported in achieving their career goals. Stout provides flexible work schedules and a discretionary time off policy to promote work-life balance and help employees lead fulfilling lives.

Role Description We are seeking a dynamic and detail-oriented individual to oversee key compliance functions including prevention of money laundering process and operations, trade surveillance. The ideal candidate will ensure robust detection and mitigation of suspicious activities, regulatory reporting, and internal policy development aligned with current compliance requirements in the crypto and related fintech sectors. FIU Operations: - Manage AML processes to detect, investigate, and report suspicious activities in a timely manner. - File Suspicious Transaction Reports (STRs) to concerned authority in compliance with requirements. - Respond to FIU alerts, queries, and emails, ensuring accurate and timely communication. Trade Surveillance: - Design and implement effective surveillance mechanisms to monitor trading activity and detect market abuse, insider trading, or manipulative behaviour. - Investigate suspicious trading patterns and escalate issues as required. - Enhance surveillance frameworks in line with market practices and regulatory expectations. AML Compliance: - Ensure organization-wide compliance with applicable AML/CFT regulations and internal standards. - Conduct periodic AML audits and ensure compliance with Know Your Customer (KYC) and Enhanced Due Diligence (EDD) standards. Policy Development and Training: - Develop, maintain, and revise compliance policies and SOPs based on evolving regulatory norms. Regulatory Reporting & Liaison: - Prepare and submit accurate reports within prescribed timelines to the authorities. - Stay abreast of changes in compliance regulations, particularly in the crypto and financial services industries. - Build strong working relationships with relevant authorities and enforcement agencies. Team Collaboration: - Work closely with internal teams including legal, finance, risk, and operations to embed compliance into business processes. - Provide compliance inputs for new products, services, and partnerships. Qualifications - Prior experience in AML/CFT, or trade surveillance roles—preferably within the crypto, broking, or fintech sectors. - Understanding how to identify and assess risk factors related to money laundering and terrorist financing, and tailoring compliance measures accordingly. - Knowledge of STR filing, surveillance tools, and AML/KYC frameworks. - The ability to conduct and interpret risk assessments related to money laundering and terrorist financing is essential. - Screening for any criminal records or past offenses that might indicate a lack of trustworthiness or suitability for the role. - Familiarity with sanctions screening procedures and the ability to identify and report individuals or entities that appear on sanctions lists. - Relevant certifications will be an added advantage. - Technical skills to use AML/CFT software, databases, and other tools used in the compliance process. - Strong analytical skills and attention to detail.

Role Description The Compliance Manager plays a critical role in safeguarding the organization’s adherence to regulatory requirements and industry standards by overseeing regulatory monitoring, managing rate and form filings, audit preparation, and compliance readiness. This role involves actively identifying compliance needs, coordinating and delivering necessary training, and ensuring that all employees understand relevant regulations. As part of Risk Management and Corporate Governance, the Compliance Manager assesses and mitigates potential risks, ensuring alignment with internal policies and legal standards. This role requires a proactive, detail-oriented approach to continuously improve compliance processes, reduce risk, and support the organization’s commitment to ethical and compliant operations. Qualifications - A bachelor’s degree in business administration, finance or a related field is preferred. Advance degree a plus. - An Institutes or AICP designation preferred (ARM, ARC, ACP, CCP). - 5+ years of professional experience in insurance operations and compliance/risk management. - 3+ years of experience researching state insurance laws, regulations and state license requirements and facilitating state insurance department filings. Requirements - Serve as administrator for MEM’s Code of Conduct hotline. - Maintain MEM’s web portal page and investigator data with third party vendor and ensure reports of concern are received and investigated. - Oversee submissions of all state regulatory filings by coordinating and submitting all, annual rate, rule and form filings, business entity filings with the Secretary of State, NAIC license/expansion filings, biographical affidavits for directors and officers, and corporate governance annual disclosures. - Prepare or facilitate responses to regulator inquiries and objections to filings. - Draft and edit policy forms, endorsements, notices and related correspondence for regulatory filing and approval. - Monitor and communicate status of filings to internal business partners. - Collaborate with internal departments to develop, implement, and maintain regulatory compliance policies and procedures. - Lead the Compliance Committee and ensure the Committee regularly updates and maintains compliance with the Compliance Calendar. - Ensure legal and regulatory changes are monitored and any business impacts are understood. - Provide compliance research and support to MEM for various regulatory jurisdictions as required. - Respond to or coordinate responses to regulatory inquiries as required, such as complaints and market conduct inquiries. - Maintain required logs and documentation. - Maintain relationships with associations or industry groups to stay abreast of regulatory requirements and industry compliance trends. - Conduct regular compliance audits and risk assessments to identify potential regulatory issues. - Resolve issues arising from audits and refer serious or contentious issues to the Director of Legal and Compliance. - Work with IT in the development of compliance training and education for MEM employees related to data security. - Participate as a member of the Business Continuity Team actively contributing in matters related to Records and Information Management. - Maintain an active role in the corporate governance model throughout the year. - Serve as member of the Business Continuity and Corporate Data Security Incident Response Team. - Conduct risk assessments to evaluate product, compliance, or operational risks. - Coordinate an annual data security breach exercise with relevant stakeholders to drive readiness. - Serve on the Emerging Risks Team to identify and mitigate new and emerging risks. Benefits - Health Plans: Medical, Dental, and Vision, including fertility benefits, fully paid preventative care, and adult orthodontia. - Annual Performance Based Bonus. - Employer-Paid Life and Disability Benefits: Life Insurance (3x base salary), AD&D, Short and Long-term Disability. - Wellness and Recognition Program: Employer-paid incentives for employees and spouses. - Flexible Spending Account and Dependent Care options. - Health Savings Account: Generous employer contribution. - Generous PTO, 11 Holidays + 4 Early Releases, 16 Hours Volunteer Time Off, 20 Days Paid Parental Leave, Marriage, Bereavement, and Jury Duty leave. - Employee Assistance Programs. - 401k Retirement Plan: Employer match and profit sharing. - Adoption Assistance and Tuition Assistance.