Head of Global Regulatory Affairs Labeling at Takeda

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Job Description

About the role:

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. The Head of Global Regulatory Affairs Labeling is a key leadership role in the PDT R&D organization accountable for providing guidance and oversight for the global labeling function.

How you will contribute:

• Accountable for oversight for Takeda’s Plasma-Derived Therapies Business Unit’s Global Labeling function and the formulation of regulatory labeling strategies for implementation of new and revised prescribing information and packaging; strategically interprets scientific, medical, and regulatory data and information.

• Actively participates on the PDT Global Regulatory Affairs Leadership Team, providing input on key strategic, portfolio, human capital, and financial decisions.

• Leads, mentors, and manages the assigned team of Global labeling Leads within the Global Program Team and ensures GRT program coverage for PDT products.

• Provides regulatory expertise and guidance to Clinical, Pharmacovigilance, Legal, Scientific, Commercial, and other internal stakeholders for successful development of Company Core Data Sheets (CCDSs) and global labeling, i.e., US and EU (CP, MRP, and DCP) for PDT BU products.

• Oversight and accountability for labeling activities managed by external vendor(s) for assigned products, ensuring seamless coordination, timely delivery, and adherence to quality standards.

• Provides proactive leadership, strategic regulatory guidance, and expert advice on current labeling requirements, templates, tools and Health Authority-issues guidance across the portfolio of PDT products.

• Co-chairs the process to obtain labeling approval by Labeling Senior Management Cross-functional team (Global Labeling Oversight Committee – GLOC) providing leadership to foster cross-functional collaboration and drive alignment of the labeling strategy and labeling content at all levels.

• Works collaboratively with regional Regulatory Heads, overseas and directs the creation of high quality, complaint regulatory labeling documents.

• Ensures program teams, regulatory 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.

• Demonstrates ability to anticipate risks and responsible for developing solutions to identified risks and discussing with the assigned team and management; understands probabilities of technical success for the solutions.

• Oversees team of labeling leads accountable for labeling review and finalization across all development programs and works collaboratively with the Global Regulatory Program Strategy team to bring any critical labeling-related topics to the regulatory review forum for discussion.

DIMENSIONS AND ASPECTS:

• Demonstrated ability to lead cross-functional teams, develop and implement global regulatory strategies, facilitate approvals, resolve complex issues, and negotiate optimal regulatory pathways and outcomes with health authorities.

• Ability to use precedent and previous experience to develop innovative and flexible approaches to achieve commercial goals.

• Appreciates and interprets complex scientific issues across projects and therapy area(s) as it relates to regulations and strategy for the PDT BU.

• Strong influencing and negotiation skills, integrity, and adaptability. Outstanding written and oral communication skills as well as managing and adhering to timelines.

• Broad experience in US and Global Regulatory Affairs, including experience with INDs, BLAs/NDAs, MAAs, Pediatric Investigation Plans, Orphan Drug designations, rare disease drug development, innovative trial design and/or expedited regulatory pathways.

• Advanced knowledge of US and/or EU regulatory requirements and guidelines and proactive evaluation of evolving regulatory labeling landscape.

• Ability to independently create, revise and/or update product labeling (i.e. CCDS, USPI and EU SmPC) for regulatory submissions.

• Ability to review product labeling for regulatory submissions and to provide pertinent feedback to ensure compliance with regulations and alignment with portfolio strategy and business objectives.

• Ability to independently develop target labeling profile (TLP).

• Strong understanding of global labeling processes, implications across the organization and globally, and impact of the scientific principles of quality, nonclinical and clinical data on product labeling.

• Knowledge of Health Authority audit process and ability to participate in partner/health authority audits and inspections.

Leadership

• Ability to lead, motivate, mentor, and manage a diverse team in a matrix environment.

• 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 (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 exercise 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 multiple stakeholders to drive solutions and set priorities.

• 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.

• Ability to challenge self and others to overcome regulatory barriers and deliver high quality solutions to the business.

• Ability to negotiate and influence without authority in a matrix environment.

• Crisp decision-making following appropriate consultation, even in times of ambiguity.

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.

• Exceptional communication, negotiation, presentation, and influencing skills across internal and external stakeholders.

Innovation

• Disruptive thinker with the ability to influence and change how PDT 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 exceptional 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.

Minimum Requirements/Qualifications:

• BSc degree preferred and advanced scientific degree (MSc, PhD, or PharmD) a plus.

• 10+ years of pharmaceutical industry experience. This is inclusive of 8 years of labeling experience or combination of 6+ years regulatory and/or related experience.

• Significant pharmaceutical background with a focus on regulatory and/or both development and post-marketing phases in the US and EU.

• Ability to use precedent and previous experience to develop innovative/flexible approaches to achieve commercial goals.

• Crisp decision-making following appropriate consultation, even in times of ambiguity.

• Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.

• Must work well with others and within global teams.

• Demonstrated leadership skills and ability to inspire colleagues and influence in a matrixed Environment.

• Travel up to 20%

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.

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:

U.S. Base Salary Range:

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-termincentives. 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