Head, Global Regulatory Affairs Device, PDT

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About the role:

Plasma-derived therapies are critical, life-saving medicines, which patients with rare and complex diseases around the world rely on every day. Global demand for these therapies, particularly immunoglobulins, has increased dramatically over the last 15 years, and continues to grow. Takeda is established as second largest provider of plasma-derived therapies (PDT) globally. Leveraging on 75+ year pioneering legacy, Takeda believes there is tremendous potential to do more to meet expectations of patients and health care providers with plasma-derived therapies for patients with immunologic, hematologic, autoimmune and other complex diseases. As a member of the PDT R&D team based in our Cambridge, MA office, you will report to the Head, Global Regulatory Affairs CMC & Device, PDT.

How you will contribute:

• Define, coordinate, and implement global device regulatory strategies for product portfolio-specific development and life-cycle activities for drug-device combination products, software as/in a medical device (SaMD/SiMD) and standalone medical devices.

• Manage PDT Global RA Device function. Provide proactive leadership and strategic guidance to the assigned PDT Global Regulatory Device Team Leads for defining global regulatory device strategies and objectives about the development, registration, commercialization, and lifecycle management of plasma-derived therapies in the United States, European Union and international markets.

• Oversee global agency interactions for devices with the US FDA and discussions with international health authorities and agencies for device-related matters. Negotiate with regulatory authorities during the development process to ensure submission acceptance and approval.

• Through active participation in the PDT Global RA CMC & Device leadership team, the Head, Global Regulatory Affairs Device, PDT guides and influences the device regulatory strategy of the PDT BU.

• Overseas and directs the device regulatory strategy of high quality and compliant regulatory submissions and documentation (e.g., 510(k), De Novo, PMAs, technical documentation for CE mark application, initial BLAs and MAAs, international device registrations, post-approval variations/supplements, INDs, CTAs and other relevant regulatory filings such as meeting requests and briefing packages) for the assigned product portfolio within defined timelines following R&D and our goals. Identify and recommend the most effective device regulatory strategies to assure a first-pass regulatory approval.

• Advise on new and compliant regulatory device and combination strategies, solutions to scientific problems and interpretation of results in the context of product registration requirements combined with our needs and goals. Oversee and help develop multi-country/multi-product/multi-site overarching regulatory strategies for the assigned product portfolio.

• Support the global program planning and overall regulatory device strategy discussions. This includes facilitating the communication and flow of regulatory information (regulatory framework, scope and project timelines) to all relevant partners.

Minimum Requirements/Qualifications:

• Bachelor’s degree in a scientific discipline

• 15+ years of biotechnology/pharmaceutical industry experience

• 10+ years of regulatory device experience with drug-device combination products software as device, and standalone medical devices

• 4+ years of people management experience

• Experience reviewing, authoring, and managing components of regulatory submissions

• Excellent knowledge of global regulatory device requirements and demonstrated ability to function as functional head leading a team to partner with global health authorities

• Experience in the global regulatory device environment and knowledge of global pharmaceutical/biotechnological drug development.

• Knowledge of global device regulatory requirements (e.g., EU MDR, ISO 13485, ISO 14971, ISO 15223, ISO 10993, IEC 62366, IEC 62304, IEC 60601, ISO20916, ISO 18113, ISO 23640, 21 CFR Part 820, IEC 62304:2006, ISO 14971:2019, IEC/TR 80002-1:2009, IMDRF Software as a Medical Device Framework, QSR and BIMO compliance, PFSB/MDRMPED for SaMD)

• Track record in leading successful FDA, EU and international submissions, including 513(g) negotiations, pre-submissions, IDEs, 510(k)s, PMAs, De novo 510(k)s, EU MDR product registrations, etc.

What Takeda can offer you:

• Comprehensive Healthcare: Medical, Dental, and Vision

• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan

• Health & Wellness programs including onsite flu shots and health screenings

• Generous time off for vacation and the option to purchase additional vacation days

• Community Outreach Programs and company match of charitable contributions

• Family Planning Support

• Flexible Work Paths

• Tuition reimbursement

More about us:

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.

This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

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.