Head of Global Regulatory Affairs (BioLife Plasma)
Takeda
6 months ago
Remote friendly (Cambridge, MA)
United States
Corporate Functions
Objectives/Purpose
- Serve as 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. Ensure regulatory strategy enables innovation, operational excellence, and long-term plasma supply resilience while maintaining compliance with global health authority requirements.
Responsibilities
- Provide enterprise regulatory strategy and end-to-end regulatory leadership for plasma sourcing and collection activities, BioLife medical devices, and donor-facing digital/software-enabled systems, as well as center transformation and plasma diversification initiatives.
- Develop and maintain trusted partnerships and lead regulatory collaboration across matrixed global teams and functions.
- Act as executive-level spokesperson with global health authorities, trade associations, and industry forums.
- Serve as senior regulatory interface with FDA and global health authorities for plasma sourcing; lead regulatory submissions, inspections, compliance, and lifecycle management of collection centers.
- Lead regulatory strategy for medical devices and donor-facing digital systems, including regulatory pathways for design changes, system upgrades, automation, and new technology deployment.
- Provide regulatory leadership for transformation initiatives (collection center modernization, automation, new operating models), including evolving expectations for digital health, data integrity, and integrated systems.
- Lead regulatory partnership for plasma diversification initiatives, shaping regulatory frameworks to support long-term plasma supply resilience and sustainability.
- Influence regulatory policy, standards, and guidance relevant to plasma collection, devices, and digital systems; foster transparent relationships with regulators.
Qualifications (Education)
- Bachelor’s degree required.
- Advanced degree in a scientific or health-related discipline (e.g., PhD, PharmD, MD, MS) preferred.
Qualifications (Experience/Skills)
- 15+ years in health care with extensive senior-level 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 organizations.
- Strong executive presence and ability to influence internally/externally.
- Strong technical background in US (FDA, CLIA, OSHA, State, PPTA) and international (e.g., EU) regulations related to plasma collection and/or manufacturing.
- Strong oral/written communication and negotiation skills.
- Ability to motivate, mentor, and manage diverse teams in a matrix environment; collaborate cross-functionally.
- Ability to develop and implement regulatory strategies, facilitate approvals, resolve complex issues, and negotiate optimal regulatory pathways/outcomes.
Additional Information
- 30–35% domestic and international travel required.
- Serve as 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. Ensure regulatory strategy enables innovation, operational excellence, and long-term plasma supply resilience while maintaining compliance with global health authority requirements.
Responsibilities
- Provide enterprise regulatory strategy and end-to-end regulatory leadership for plasma sourcing and collection activities, BioLife medical devices, and donor-facing digital/software-enabled systems, as well as center transformation and plasma diversification initiatives.
- Develop and maintain trusted partnerships and lead regulatory collaboration across matrixed global teams and functions.
- Act as executive-level spokesperson with global health authorities, trade associations, and industry forums.
- Serve as senior regulatory interface with FDA and global health authorities for plasma sourcing; lead regulatory submissions, inspections, compliance, and lifecycle management of collection centers.
- Lead regulatory strategy for medical devices and donor-facing digital systems, including regulatory pathways for design changes, system upgrades, automation, and new technology deployment.
- Provide regulatory leadership for transformation initiatives (collection center modernization, automation, new operating models), including evolving expectations for digital health, data integrity, and integrated systems.
- Lead regulatory partnership for plasma diversification initiatives, shaping regulatory frameworks to support long-term plasma supply resilience and sustainability.
- Influence regulatory policy, standards, and guidance relevant to plasma collection, devices, and digital systems; foster transparent relationships with regulators.
Qualifications (Education)
- Bachelor’s degree required.
- Advanced degree in a scientific or health-related discipline (e.g., PhD, PharmD, MD, MS) preferred.
Qualifications (Experience/Skills)
- 15+ years in health care with extensive senior-level 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 organizations.
- Strong executive presence and ability to influence internally/externally.
- Strong technical background in US (FDA, CLIA, OSHA, State, PPTA) and international (e.g., EU) regulations related to plasma collection and/or manufacturing.
- Strong oral/written communication and negotiation skills.
- Ability to motivate, mentor, and manage diverse teams in a matrix environment; collaborate cross-functionally.
- Ability to develop and implement regulatory strategies, facilitate approvals, resolve complex issues, and negotiate optimal regulatory pathways/outcomes.
Additional Information
- 30–35% domestic and international travel required.