Head of Global Regulatory Affairs - Plasma Sourcing & Collection, PDT
応募後で応募 求人ID R0106026 掲載日 09/12/2023 Location:Bannockburn, IllinoisBy clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
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.
The PDT BU R&D group is dedicated to bringing forward new therapeutic approaches based on plasma-derived therapies for patients with rare and complex diseases. Takeda believes there is tremendous potential to do more to meet patients’ and health care providers’ expectations with plasma-derived and plasma-oriented therapies for patients with immunologic, hematologic, and other complex diseases. Reporting to the VP, Head of Global Regulatory Affairs - Plasma, CMC and Device, PDT, in our Bannockburn, IL office, you will provide proactive leadership, strategic guidance for the BioLife US plasma sourcing group by defining and optimizing regulatory strategies, and policies for the development, registration and lifecycle management of source plasma collection and collection centers globally.
How you will contribute:
Provide proactive leadership and strategic guidance to the Global Regulatory Affairs - Plasma Sourcing & Collection organization by defining regulatory strategies and policies about the operation of collection and sourcing of human plasma.
Work with Global Regulatory Affairs CMC & Device, Quality, Medical Affairs, Operations, IT and other business functional heads to provide a streamlined, coordinated and global approach to plasma sourcing
Direct the creation of high quality, compliant regulatory documents (e.g., BLAs, INDs, Variations/Supplements, CLIA, PPTA, state and other relevant regulatory filings) across the BioLife portfolio of programs within defined timelines
Be the primary contact point and liaison with state, federal and other international regulators to obtain timely health authority decisions and guidance.
Engage with external consultants and advisers for strategic input and guidance on the regulatory landscape to ensure strategies are deployed and innovative approaches are implemented.
Represent BioLife as an authorized official or responsible person in interactions with regulatory agencies
Take a leadership role and engage with Takeda State Government Affairs in supporting legislative or statutory changes in plasmapheresis requirements
Lead the development of strategic objectives, plans and programs for Regulatory Affairs
Advise senior management concerning regulatory requirements and the impact on project status and company compliance
Provide consultation to other BioLife areas (e.g., medical quality, operations, IT) for developing business processes that impact regulatory compliance
Ensure that regulatory policies and procedures are written and implemented following all applicable international, federal (FDA, CLIA, OSHA), state, local and industry (ISO, IQPP) regulations and requirements.
Develop and implement programs, policies and standard operating procedures to meet global regulatory requirements
Minimum Requirements/Qualifications:
Bachelor’s degree required
10+ years in a regulatory role of increasing responsibilities in the biologics or plasma field
Technical background including familiarity with US (FDA, CLIA, OSHA, State, PPTA) and International (e.g., EU) regulations related to plasma collection or manufacturing
Experience reviewing, authoring and managing components of US (federal and state level) regulatory submissions
Previous experience motivating and managing a diverse team in a matrix environment
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 Ways of Working
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.