Head of Global Regulatory Affairs (BioLife Plasma)

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Job Description

About BioLife Plasma Services

BioLife Plasma Services a subsidiary of Takeda Pharmaceutical Company Limited is an industry leader in the collection of high-quality plasma which is processed into life-saving plasma-based therapies. Some diseases can only be treated with medicines made with plasma. Since plasma cant be made synthetically many people rely on plasma donors to live healthier happier lives. BioLife operates 250 state-of-the-art plasma donation centers across the United States. Our employees are dedicated to enhancing patients quality of life and ensuring that the donation process is safe straightforward and rewarding for donors who wish to make a positive impact.

When you work at BioLife youll feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors well support you. We offer a purpose you can believe in a team you can count on opportunities for career growth and a comprehensive benefits program all in a fast-paced friendly environment.

This position is currently classified as hybrid in accordance with Takedas Hybrid and Remote Work policy.

BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd.

OBJECTIVES/PURPOSE

The Global Head of BioLife Regulatory is an enterprise regulatory leader responsible for defining and executing global regulatory strategy across BioLife plasma sourcing collection diversification medical devices donor interaction systems (DIS) and plasma center transformation initiatives. This role ensures that the regulatory strategy enables innovation operational excellence and long-term plasma supply resilience while maintaining compliance with global health authority requirements. The VP serves as a strategic partner to BioLife PDT (Plasma Derived Therapies) R&D Quality Operations and Global Regulatory Affairs (CMC and Device) and represents the organization at senior levels with regulators and industry bodies.

The Global Head of Global Regulatory Affairs for BioLife:

• Provides enterprise regulatory strategy and end-to-end regulatory leadership for plasma sourcing and collection activities BioLife medical devices and donor-facing digital and software-enabled systems BioLife center transformation initiatives and plasma diversification initiatives.
• Builds strong trusted partnerships with key strategic partners within BioLife PDT R&D and the PDT BU and leads regulatory collaboration across matrixed global teams and functions.
• Serve as an executive-level spokesperson with global health authorities trade associations and industry forums.

ACCOUNTABILITIES

• Enterprise regulatory strategy & leadership including defining and executing enterprisewide regulatory strategy for BioLife plasma sourcing and collection that is aligned with PDT and Takeda objectives providing seniorlevel regulatory leadership to enable BioLife growth modernization and diversification initiatives serving as a key advisor to executive leadership on regulatory risk policy trends and longrange strategic planning and ensuring regulatory considerations are embedded early in business technology and R&D decisionmaking.
• Global regulatory strategy for plasma collections across all operations regions acting as senior regulatory interface with FDA and global health authorities for plasma sourcing activities and providing leadership for regulatory submissions inspections compliance and lifecycle management of collection centers.
• Endtoend regulatory leadership for BioLife medical devices and donorfacing digital and softwareenabled systems including regulatory pathways for design changes system upgrades automation and new technology deployment and partnering closely with Global RA CMC & Device Quality IT/Digital and Operations to ensure compliant and scalable technology solutions.
• Regulatory leadership for BioLife transformation initiatives including collection center modernization automation and new operating models enabling innovation through proactive regulatory strategy that supports futurestate collection and donor engagement models and anticipating evolving regulatory expectations related to digital health data integrity and integrated systems.
• Global strategic regulatory partner for plasma diversification initiatives including supporting expansion across geographies donor engagement approaches and technology platforms and shaping regulatory frameworks to support longterm plasma supply resilience and sustainability.
• External and industry engagement including serving as an executivelevel spokesperson with global health authorities trade associations and industry forums influencing regulatory policy standards and guidance relevant to plasma collection devices and digital systems and fostering constructive transparent and trustbased relationships with regulators worldwide

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

• Extensive knowledge of regulatory requirements and demonstrated ability to function as the lead interface with Regulatory Authorities (e.g. cGMP FDA CLIA OSHA EU State PPTA).
• Demonstrated ability to develop and implement 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 goals.

Leadership

• Ability to 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.
• Able to influence without authority at the senior leadership level.

Decision-making and Autonomy

• Accountable for acting decisively and exercising sound judgment in making decisions with limited information.
• Ability to challenge self and others to overcome regulatory barriers and deliver high-quality solutions to the business.
• Accountable for making clear business arguments and strategic recommendations leveraging both quantitative and qualitative evidence.

Interaction

• Valuing and promoting differences by recognizing the importance of connections and bringing in key stakeholders to work towards the best possible solutions.
• Exceptional communication negotiation presentation and influencing skills across internal and external stakeholders.

Innovation

• Disruptive thinker with the ability to influence and change how BioLife uses data to make decisions and set priorities.
• 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.
• Recommends key decisions escalates key issues per agreed governance framework and persuades key stakeholders through exceptional influencing skills.
• Resilient and comfortable working through large-scale global change management

EDUCATION BEHAVIOURAL COMPETENCIES AND SKILLS:

• Bachelors degree required. Advanced degree in a scientific or healthrelated discipline (e.g. PhD PharmD MD MS) preferred
• 15 years in health care with extensive seniorlevel experience in global regulatory affairs within biologics plasma medical devices and/or digital health
• Demonstrated experience engaging with FDA and global health authorities at senior levels.
• Proven ability to lead through transformation complexity and matrixed organizational structures.
• Strong executive presence with the ability to influence internally and externally.
• Strong technical background including familiarity with US (FDA CLIA OSHA State PPTA) and International (e.g. EU) regulations related to plasma collection and/or manufacturing.
• Demonstrated ability to lead teams and collaborate with key cross-functional areas.
• Strong oral and written communication and negotiation skills
• Highest level of compliance integrity and business adaptability

ADDITIONAL INFORMATION

• 30-35% Domestic and international travel required.

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.

BioLife Compensation and Benefits Summary

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 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.

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Job Exempt