Associate Director - Strategist Global Regulatory Affairs, CMC

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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.

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 Lead, CMC Regulatory Affairs, Plasma-Derived Therapies Business Unit in our Cambridge, MA office, you will develop global CMC regulatory strategies for assigned programs.

How you will contribute:

• Contributes to the development of CMC regulatory strategies in close collaboration with relevant Takeda R&D, PDT BU R&D and Commercial functions to obtain, maintain and extend Takeda PDT BU product registrations in the United States, Japan, the European Union, Canada and emerging markets.

• Maintain GRA CMC Regulatory Affairs effectiveness for ongoing development and lifecycle management activities for assigned programs.

• Provide proactive guidance and regulatory strategies to support PDT product teams.

• Remain knowledgeable about current CMC regulations and guidances and interpret the global CMC regulatory environment to provide proactive guidance to team members based on technical and regulatory knowledge and to guide the development of strategic regulatory plans.

• Create high quality, compliant CMC regulatory documents (eg, Core Dossiers, CTAs, MAAs, NDS, Variations and other relevant regulatory CMC filings) within defined timelines following Takeda PDT BU goals.

• Work with GMS and PDT BU R&D functions in the preparation and approval of CMC regulatory filings to support early and late stage development assets, and the maintenance or expansion of approved Plasma-Derived Therapies globally.

• Work with global regulatory agencies, especially the US Food and Drug Administration and international regulatory agencies to develop professional relationships and promote a positive company image.

Minimum Requirements/Qualifications:

• 2+ years of experience in global drug/biologics development in the biopharmaceutical or biotechnology industry, or Government Health Authorities.

• 2+ years in a Regulatory Affairs CMC role

• Knowledge of global regulatory requirements and demonstrated ability to function as the lead interface with global Regulatory Authorities.

• Knowledge of the global drug discovery and development process, laws and CMC regulations affecting biopharmaceutical development in US, EU and international markets.

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.