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Manager, Global Regulatory Affairs CMC Submissions Management

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Job ID R0054323 Date posted Dec. 01, 2021 Location Boston, Massachusetts

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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.

Join Takeda as a Manager, Global Regulatory Affairs CMC Submissions Management where you will drive 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. You will also establish the document plan, negotiate timelines with authors, drive all deliverables against the timeline, compile all submission ready documents, and deliver the final submission components to the Publishing team. As part of the Global Regulatory Affairs CMC Submissions Management team, you will report to the Director and manage a team of experts including Pharmaceutical Sciences representatives, Quality representatives, and cross-functional stakeholders in Regulatory.

How you will contribute:

  • 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 management

    • QC, 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

What you bring to Takeda:

  • 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, Analytical Development, Production, Quality Assurance).
  • Familiarity with global regulatory guidelines and experience in regulatory submission (CMC Module 3 information and QOS documents) is essential
  • Demonstrate attention to detail and problem-solving abilities.
  • Exercise appropriate judgement when working with project teams.
  • Exercise good judgement in elevating and communicating actual or potential issues to line management.
  • Excellent written and oral communication skills.

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.

Absent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. US field-based employees must be fully vaccinated as a condition of employment, absent an approved religious or medical reason. US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. If you are contacted by a Takeda recruiter about your job application, we encourage you to seek more information on the applicable guidelines for the Business Unit/Function to which you have applied.


In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

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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

Boston, MA

Lexington, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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