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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. 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.

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 Therapeutic Area Global Regulatory Strategy Lead in our Cambridge, MA office, you will be the regulatory strategist for one or more projects and coordinate the Global Regulatory Team (GRT) meetings composed of core regulatory support functions.

How you will contribute:
• Help with the creation and execution of global regulatory strategies for assigned programs and ensures the global regulatory strategies for assigned programs are up-to-date
• Collaborate with EU, Japan, China and other regional counterparts in compiling global regulatory strategies and works cross-functionally with RA and R&D program team members to ensure deliverables to countries/regions outside the US are achieved and execution of the strategy is met
• Support the creation and submission of high quality, compliant regulatory documents (e.g., BLAs, INDs, CTAs, MAAs, Variations/Supplements and other relevant regulatory filings such as PIPs/PSPs, ODDs, meeting requests and briefing packages) for assigned programs within defined timelines following R&D and business objectives
• Responsible for regulatory submissions for assigned programs under the oversight of Global Regulatory Lead
• Help with FDA health authority interactions/meetings related to assigned programs and support regional and local regulatory affairs teams with health authority interaction
• Ensure accurate, up-to-date reporting of program status and milestones globally through the InterACT system and regulatory dashboard and uses the Dragonfly visualization tool to highlight any major discrepancies for assigned programs Collaborates with LOCs to identify the documents required for submissions, identifies responsible PDT subject matter experts and facilitates alignment on deliverables

Minimum Requirements/Qualifications:
• Bachelor's degree required
• Minimum of 2 years of pharmaceutical industry experience, with 1 year of within a regulatory role
• Experience reviewing, authoring, or managing components of regulatory submissions
• Knowledge of global regulatory requirements and prior FDA interactions/submissions experience
• Use precedent and previous experience to develop new and flexible approaches to achieve commercial goals
• Demonstrate skills and ability to work well in a matrixed 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.

Locations

Cambridge, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
Cambridge MA USA

Salary Criteria