Associate Director Regulatory Affairs

The Plasma-Derived Therapies (PDT) R&D Organization is dedicated to bringing forward new plasma-derived therapies for patients with immunologic, hematologic, and other complex diseases. There are two main drivers of innofvation that are the focus of the PDT R&D organization: Translational Pharmaceutical Sciences and Precision Medicine

The Global Regulatory Labeling Strategy Lead (Associate Director), Plasma-Derived Therapies Business Unit (PDT BU) is a key role in Global Labeling and works under the direction of the Head of Global Labeling and is:

• Responsible, with minimal supervision for providing regulatory expertise, strategic insight, and guidance to internal stakeholders, including Clinical, Pharmacovigilance, Legal, Scientific, Commercial, to ensure successful development and maintenance of labeling managed within PDT BU’s Global Labeling function, pertaining to pharmaceutical drug and device.
• Ensuring that there is strategic labeling input in the implementation of regulatory strategies and liaises with regulatory team members in evolving submission and negotiation plans.
• Formulating regulatory labeling strategies for implementation of new and revised prescribing information and packaging; strategically interprets scientific, medical, and regulatory data and information.
• Providing expert advice on current labeling requirements, templates, tools, and Health Authority-issued guidance pertaining to pharmaceutical drug and device.

ACCOUNTABILITIES

• Drives labeling strategy for the PDT BU via the development and lifecycle management of the CCDS, US, and EU labels.
• Formulates and implements innovative regulatory strategies for labeling development to support successful commercialization of developmental products and enhance opportunity for marketed products and global expansion.
• Prepares strategic labeling vision for early development programs and gains alignment from internal stakeholders.
• Draws on labeling precedent, Health Authority feedback, and guidance, to create innovative labeling strategies.
• Provides guidance on combination product/drug-device labeling.
• Interprets scientific and clinical data and leads development of labeling to optimize product potential and patient benefit-risk ratio.
• Introduces creative solutions for data presentation and gains consensus by labeling teams to meet the requirements of the Health Authorities
• Prepares backup strategies in support of labeling negotiations.
• Takes initiative in leading global labeling team and cross-functional projects.
• Leads CCDS, US, and EU Labeling Teams in the development and maintenance of labeling.
• Actively engages cross-functional labeling stakeholders to gain consensus on labeling strategy.
• Effectively identifies and resolves conflicts/issues to reach labeling decisions with minimal escalation to management for dispute resolution.
• Liaises with Regulatory Intelligence to maintain awareness of regulatory legislation pertaining to labeling and communicates the impact on the PDT BU products.
• Provides guidance to Regulatory affiliates as necessary in assessment of labeling changes to ensure timely implementation.

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

• In close collaboration with the Takeda R&D labeling function, oversees the direction, management and implementation of the labeling processes, templates, tools and systems to improve efficiency, productivity and quality and consistency across products and compliance with regulatory labeling guidance.
• Project manages new or updated labeling to ensure compliance with internal procedural or Health Authority submission timelines.
• Manages and facilitates review of CCDSs and regional labeling, as appropriate, via the Labeling Team and executive governance committees for PDT BU products.
• Prepares final proposed labeling for review by the Labeling Team and approval by the executive governance committees, as appropriate, prior to internal approval and/or submission to health authorities.
• Manages the preparation of submission-ready labeling components, consults with affiliates on Health Authority communications regarding labeling.
• Ensures internal and external stakeholder awareness of proposed and newly approved labeling changes, as required.
• Ensures compliant version control of product labeling and other related documentation within the Takeda document management systems.
• Ensures QC of CCDSs and other labeling documents.
• Updates labeling decision records to ensure labeling history is appropriately tracked and archived.
• Ensures Takeda employee awareness of, and adherence to, Takeda Labeling processes via regulatory training.
• Designs and delivers labeling training programs.
• Documents labeling tracking information as required in end to end tracking systems to facilitate overall compliance and oversight of labeling activities

Leadership

• Ability to motivate, mentor and manage diverse cross functional teams
• Global perspective with a demonstrated ability to work across functions, regions, and cultures
• Ability to identify potential challenges and opportunities and make recommendations
• Proven skills as an effective collaborator who can engender credibility and confidence within and outside the company
• Valuing and promoting differences by embracing and demonstrating a diversity and inclusion mindset and models these behaviors for the organization
• Invests in helping others learn and succeed
• Able to influence without authority at senior level (TET/TET-1, GLOC)
• Demonstrates agile leadership by seeking to understand with the ability to evolve ideas as needed.
• Interviews, mentors, and develops employees/consultants.
• Builds and enhances strategic, cross-functional, stakeholder relationships through thoughtful engagement and leadership (including, the planning, assigning, and direction of work).

Decision-making and Autonomy

• Accountable for acting decisively and exercise sound judgment in making decisions with limited information
• Accountable for making clear business arguments and strategic recommendations leveraging both quantitative and qualitative evidence
• High ability to seek diverse input by balancing multiple internal and external multiple stakeholders to drive solutions and set priorities
• High 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
• High ability to challenge self and others to overcome barriers and deliver high quality solutions to the business.
• Crisp decision-making following appropriate consultation, even in times of ambiguity.
• Self-starter. Demonstrates initiative in advancing strategic projects with minimal guidance.

Interaction

• Organizational savvy and leverages internal network to enable alignment and effective execution in and outside the BU
• Valuing and promoting differences by recognizing the importance of connections and brings in key stakeholders to work towards the best possible solutions
• Strong communicator, able to persuasively convey ideas verbally and in writing

Innovation

• Disruptive thinker with the ability to influence and change how RnD used data to make decisions and set priorities
• Continuously challenging the status quo and bringing forward innovative solutions
• Ability to identify areas for process and systems innovation and implement change that will enhance the overall effectiveness of the team.

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, and persuades key stakeholders through influencing skills.
• Creates clarity of accountabilities in a global and highly matrixed organization, with a high degree of complexity
• Ability to provide data that will resolve or simplifies complexity between commercial, operations, and strategy
• Resilient and comfortable working through large scale global change management
• Knowledge of the global drug discovery and development process, laws and regulations affecting biopharmaceutical development in US, EU and international markets.

EDUCATION AND EXPERIENCE REQUIREMENTS

• Minimum of 7-10 years of experience in the biopharmaceutical industry (e.g., safety, ad promo, regulatory strategy, medical affairs, etc.). 5-7 years of direct experience in a global, US, or EU labeling role is desired.
• Experience in plasma-derived therapies and biologics preferred.
• Bachelor’s or Master’s degree required. Advanced scientific or health sciences degree or equivalent relevant experience preferred.
• Previous leadership experience and management of direct reports preferred.
• Must have a detailed understanding of pharmaceutical drug and device development and global regulations pertaining to labeling, specifically, EU and US labeling requirements and guidance. Combination product/drug-device labeling knowledge is preferred. Advertising and promotion knowledge is a plus.
• Expertise in the development and maintenance of the Company Core Data Sheet, the USPI, and the EU SmPC.
• Understanding of SPL format, requirements and guidance for legacy and PLR labels.
• Proficiency in Electronic Document Management Systems and End-to-End (E2E) Labeling Tracking Systems to support labeling documentation, tracking, and compliance activities.

Location: Cambridge, MA (Hybrid)