Head of Global Regulatory Affairs Operations, Compliance & Process Excellence (Senior Director)

Overview

Head of Global Regulatory Affairs Operations, Compliance & Process Excellence (Senior Director) – role at BioSpace, as described in the job posting. The Plasma-Derived Therapies (PDT) R&D Organization focuses on bringing forward new plasma-derived therapies for patients with immunologic, hematologic, and other complex diseases. This position is responsible for overseeing Global Regulatory Affairs Operations across the entire PDT BU portfolio of products.

Responsibilities

• Play a key strategic role in supporting the Global RA business by overseeing all PDT regulatory submissions globally to ensure proper resourcing, planning and on-time execution from a project management and submission support perspective.
• Provide strategic leadership for end-to-end regulatory compliance and process efficiencies across the PDT organization.
• Drive and manage the strategic and collaborative relationship between PDT Global Regulatory Affairs and the Takeda R&D GRA Operations organization, as well as all contracts with 3rd party vendors (ICON, FREYR).
• Actively participate in the PDT BU Regulatory Affairs leadership team, providing input on key strategic, portfolio, human capital and financial decisions.

How You Will Contribute

• Responsible for overseeing the strategic planning and implementation of global regulatory submissions across PDT products.
• Works closely with 3rd party vendors to plan, track and manage submissions and information management for all PDT products globally.
• Works with functions & LOCs to ensure oversight and up-to-date communication on planned submissions.
• Identifies and escalates risks pertaining to submission planning and execution.
• Ensures a system within PDT RA for driving regulatory quality compliance and efficiency across the organization.
• Accountable for PDT BU compliance (e.g., PDUFA, XEVMPD, IDMP, Commitments, etc.).
• Provides strategic insight into resource requirements pertaining to submission requirements.
• Responsible for negotiating, managing, and maintaining current contractual relationships with 3rd party vendors supporting PDT BU from an RA perspective.
• Works closely with R&D to ensure alignment on strategies pertaining to 3rd party vendor and other projects.
• Provides strategic guidance and insight into budget spend and forecasting for 3rd party vendors and projects.
• Serves as an active member of the PDT BU Regulatory Affairs leadership team.
• Works in a highly matrixed, GPT-oriented environment and ensures close collaboration with other PDT BU functions and relevant Takeda R&D functions.

Dimensions and Aspects

Technical/Functional Expertise

• Comprehensive understanding of the pharmaceutical industry.
• Global pharmaceutical expertise with demonstrated strong ability for collaboration and team leadership.
• Demonstrated knowledge and understanding of global drug development and interface with commercial organization.
• Experience in operating in a multi-disciplinary drug development environment, including working within and managing across an international exposure.

Leadership

• Global perspective with a demonstrated ability to work across functions, regions, and cultures.
• Enterprise level leadership with the ability to inspire, motivate and drive results.
• Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing.
• Proven skills as an effective collaborator who can engender credibility and confidence within and outside the company.
• Ability to identify potential challenges and opportunities and make recommendations.
• Valuing and promoting differences by embracing and demonstrating a diversity and inclusion mindset.
• Invests in helping others learn and succeed.
• Able to influence without authority at senior (TET/TET-1) level.
• Demonstrates agile leadership by seeking to understand with the ability to evolve ideas as needed.

Decision-making and Autonomy

• Accountable for acting decisively and exercising sound judgment in making decisions with limited information.
• Accountable for making clear business arguments and strategic recommendations leveraging both quantitative and qualitative evidence.
• Ability to seek diverse input by balancing multiple internal and external stakeholders.
• Ability to incorporate feedback and ensure decisions are made swiftly to enable flawless execution.
• Develops executable plans and meets budget and deadlines.
• Builds a culture of data driven decisions.

Interaction

• Organizational savvy and leverages internal network to enable alignment and effective execution.
• Valuing and promoting differences by recognizing the importance of connections.
• Strong communicator, able to persuasively convey ideas verbally and in writing.
• Exceptional communication, negotiation, presentation, and influencing skills across internal and external stakeholders.

Innovation

• Disruptive thinker with the ability to influence and change how PDT uses data to make decisions.
• Continuously challenging the status quo and bringing forward innovative solutions.
• Ability to identify areas for process and systems innovation and implement change.

Complexity

• Delivers solutions to abstract problems across functional areas of the business.
• Identifies and solves fundamental issues for major functional areas through assessment of intangible variables.
• Recommends key decisions, escalates key issues per agreed governance framework.
• Creates clarity of accountabilities in a global and highly matrixed organization.
• Ability to provide data that will resolve or simplify complexity between commercial, operations, and strategy.
• Resilient and comfortable working through large scale global change management.

Minimum Requirements/Qualifications

• Bachelor\'s degree or related experience is required. Scientific or closely related field preferred.
• Project management qualification.
• 7-10 years of regulatory experience in the pharmaceutical/biotech industry.
• Experience in global drug development regulations, regulatory submissions, lifecycle management, compliance and process are required.
• Knowledge and experience of industry standard Regulatory publishing and Information Management tools is desired.
• Generally, has at least 3 years of management level experience.

Additional Information

• Demonstrated leadership skills and ability to inspire colleagues.
• Extensive knowledge of global regulatory and compliance requirements.
• Ability to use precedent and previous experience to develop innovative and flexible approaches to ensure regulatory compliance.

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.

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 $208,200.00 - $327,140.00

The actual base salary offered will depend on qualifications, experience, and location. U.S. based employees may be eligible for incentives and benefits described in the posting.

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, or other protected characteristics.

Locations: Boston, MA

Worker Type: Employee

Worker Sub-Type: Regular

Time Type: Full time

Job Exempt: Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to penalties.