Job Description

About the role:

At 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.

How you will contribute:

The Manager of GRA CMC Submission Management (CSM) R&D drives the Global CMC Submissions Team for Development submissions (IMPD/CTA/IND), Marketing Applications (NDA, MAA, BLA, JNDA), and Post-Approval Changes for where R&D deliverables are needed for commercial/GMS regulatory submissions the Research and Development (R&D) Division by managing a team of subject matter experts including Pharmaceutical Sciences representatives, Quality representatives, and cross-functional stakeholders in Regulatory. The manager establishes the document plan, negotiates timelines with authors, drives all deliverables against the timeline, compiles all submission-ready documents, and delivers the final submission components to the Publishing team. Where R&D deliverables are needed for commercial/GMS regulatory submissions, the Manager collaborates with the CSM Lead in Global Manufacturing and Supply (GSM) to prioritize documents, drive the timeline and manage the R&D stakeholders. The Manager ensures all deliverables are prioritized and tracked and delivered on time, escalates issues where they are identified, and provides strategic insight on issue resolution.

ACCOUNTABILITIES:

o Maintain doc plan / timeline

Develop TOC aligned with Reg-CMC strategy
Collaborate with Reg-CMC and Content owners to prioritize and align deliverables

o Establish document structure

Create vdoc and applicable templates

o Author management

Drive meetings for kickoff, roundtables, content / data reconciliation, and follow-ups
Lead RTQ process (e.g., Rapid Response Team)
Maintain content verification / approval workflow

o Document management

QC, formatting, uploading, filing history, headers / footers, linking, and folder / vdocstructure
Document legalization, as needed

oIssue resolution and mitigation planning activities

o Manage submission readiness

Content verification and the final quality check

o Prepare deliverables for support of submissions

Transfer TOCs
Provide submission ready docs to publishing
Archive necessary documents

Minimum Requirements/Qualifications:

BS/BA Degree in a Scientific Discipline, Advanced Degree preferred.

4+ years of pharmaceutical Regulatory CMC experience in a supportive role, or equivalent industry experience (e.g. Pharmaceutical Development, Analytical Development, Production, and Quality Assurance).

Familiarity with global regulatory guidelines and experience in regulatory submission (CMC Module 3 information and QOS documents) is essential.

Demonstrates attention to detail and problem-solving abilities.

Exercises appropriate judgment when working with project teams.

Exercises good judgment in elevating and communicating actual or potential issues to line management.

Excellent written and oral communication skills are required. 

Travel Requirements:

Ability to attend offsite meetings that may involve overnight stay.

Hybrid/Remote: Hybrid Position

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 a company match of charitable contributions
Family Planning SupportFlexible Work Paths
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.