(Senior) CMC Filing Documentation Specialist

By 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''s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAt Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.Join Takeda as a (Senior) CMC Filing Documentation Specialist where you will support documentation requirements for regulatory submissions in clinical development and for initial commercial filings. You will also work with internal and external partners to prepare and archive CMC documents in the Documentation Management System (DMS) to support regulatory submissions. As part of the Pharm Sci Operations & Partnerships/Pharmaceutical Sciences team, you will report to Manager of Documentation & Training Pharmaceutical Sciences and work with teams across the CMC Regulatory Submission function, functional area subject matter experts, Quality, external organizations (CDMOs & CMOs), and Local Operating Companies (LOCs).How you will contribute:Support documentation requirements for regulatory submissions in clinical development and for initial commercial anization support and project team participation including strategy meetings, information gathering, progress reports and presentations.Minimum Requirements/Qualifications:Bachelor''s degree with 5-7 years, or Master''s degree with 3-5 year of experience.Experience preferred in pharma/biotech documentation, contributed to regulatory submissions, to ensure that all activities are completed timely.Capable of managing multiple projects and workflows simultaneously.Degree program in a relevant scientific discipline.Experience supporting CMC components in regulatory submissions at various lifecycle together with knowledge of relevant regulatory agency guidance including ICH, FDA, EMA, and authorities in other geographic areas.Additional education or training courses in documentation and training management preferred.Experience in performing administrative responsibilities in a validated Document Management System (DMS).Good understanding of global requirements and expectations relating to CMC documents of regulatory submissions throughout the lifecycle of drug development is a plus.Knowledge of CMC documents related to drug development of both biologics, chemically synthesized products, and device/combination products.What Takeda can offer you:Comprehensive Healthcare: Medical, Dental, and VisionFinancial Planning & Stability: 401(k) with company match and Annual Retirement Contribution PlanHealth & Wellness programs including onsite flu shots and health screeningsGenerous time off for vacation and the option to purchase additional vacation daysCommunity Outreach Programs and company match of charitable contributionsFamily Planning SupportFlexible Work PathsTuition reimbursementMore 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 StatementTakeda 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.LocationsLexington, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

Created: 2025-10-04