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 Bio Space, 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.

• 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.

• 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.

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…