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Job Description
Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Lead, Regulatory Affairs CMC in our Lexington, MA office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Director working on the Global Regulatory Affairs CMC, Plasma-Derived Therapy Business Unit team, you will be empowered to ensure global strategies are successfully executed across both new product development and existing portfolio life cycle management.
The R&D organization of the Plasma-Derived Therapies Business Unit (PDT BU) 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. There will be two main drivers of innovation in the newly-formed PDT R&D group: Translational Pharmaceutical Sciences and Precision Medicine.
Under limited supervision, the Team Lead, Regulatory Affairs CMC is responsible for providing proactive leadership and strategic guidance, and develop and implement global regulatory strategies pertaining to the development, registration, commercialization and lifecycle management of Plasma-Derived Therapies in the United States and international markets. The role will serve as the liaison to, and oversees the regulatory affairs relationship with US and International Health Authorities for CMC issues pertaining to the Team Lead's assigned product portfolio, as well as to relevant Takeda business stakeholders.
Proactively contributes to the development and implementation of innovative 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.
Maintains optimal Regulatory Affairs CMC effectiveness for ongoing development and lifecycle management activities through regulatory and operational excellence within their assigned team
Provides proactive guidance and oversight to Regulatory Affairs CMC Strategists.
Remains knowledgeable about current CMC regulations and guidances and interprets the global CMC regulatory environment to provide proactive guidance to internal stakeholders based on technical and regulatory knowledge and to guide the development of strategic and tactical regulatory plans. Proactively identifies and assesses regulatory and compliance risks associated with product development and life-cycle management activities.
Creates high quality, compliant CMC regulatory documents (eg, Core Dossiers, CTAs, MAAs, NDS, Variations and other relevant regulatory CMC filings) within defined timelines as per Takeda PDT BU objectives. Directs such activity in their assigned team.
Interfaces with key GMS and PDT BU R&D functions in the preparation, review 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.
Proactively develops and fosters appropriate relationships with global regulatory agencies, especially the US Food and Drug Administration and international regulatory agencies to develop effective, professional relationships and advance a positive company image.
In partnership with other relevant functions, assists in the conduct of regulatory agency inspections and compliance audits. Ensures compliance in all GRA PDT BU activities.
Acts as an ambassador for the Takeda PDT BU Regulatory Affairs organization to influence and shape the external regulatory and policy environment.
15% - PDT BU R&D Leadership
Serves as an active member of the Regulatory Affairs CMC & Device leadership team to help influence and execute the operations and future strategy of the Takeda PDT BU R&D and Global Regulatory Affairs organization.
Works in a highly matrixed, Global Product Team-oriented environment and ensures close collaboration with other PDT BU functions and relevant Takeda R&D functions to provide an effective, common approach and partnership centrally, regionally, and locally.
Supports BioLife International Regulatory Affairs activities as directed.
15% - Culture and People Leadership
Focuses on people management, including succession planning and ability for workforce planning in one, three and five year timeframes.
Ensures a culture of transparency, innovation and teamwork. Is approachable to colleagues across Takeda and is open to the ideas of others.
Education & Experience Requirements:
Minimum of 9 years of experience in global drug/biologics development in the biopharmaceutical or biotechnology industry, or Government Health Authorities
Minimum of 6 years in a Regulatory Affairs CMC role
Minimum of 3 years in a Regulatory Affairs CMC leadership role
Global regulatory CMC experience preferred
Experience in plasma-derived therapies or biologics preferred, but not required
Advanced degree preferred, but not required
WHAT TAKEDA CAN OFFER YOU:
401(k) with company match and Annual Retirement Contribution Plan
Tuition reimbursement
Company match of charitable contributions
Health & Wellness programs including onsite flu shots and health screenings
Generous time off for vacation and the option to purchase additional vacation days
