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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:

• Maintain doc plan / timeline


• Develop TOC aligned with Reg-CMC strategy


• Collaborate with Reg-CMC and Content owners to prioritize and align deliverables


• Establish document structure


• Create vdoc and applicable templates


• 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


• Document managementQC, formatting, uploading, filing history, headers / footers, linking, and folder / vdocstructure


• Document legalization, as needed


• Issue resolution and mitigation planning activities


• Manage submission readiness


• Content verification and the final quality check


• 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 pharmaceutical Regulatory CMC experience in a supportive role, or equivalent industry experience (e.g. Pharmaceutical Development, Analyti


• cal Development, Production, 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 judgement when working with project teams.


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


• Excellent written and oral communication skills required.

Travel Requirements:

Ability to attend offsite meetings that may involve overnight stay

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 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.

Base Salary Range: $101,500 to $145,000, based on candidate professional experience level. Employees may also be eligible for Short-term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.

The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.

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

Lexington, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time