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CMC Submission Manager (HYBRID) at Takeda

CMC Submission Manager (HYBRID)

Takeda Boston, MA (On Site) Full-Time

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Job Description

Job Title: CMC Submission Manager

Reports to: Associate Director, CMC Regulatory Submissions

Location: Lexington or Cambridge, MA - Hybrid Workplace


About the role:

  • The Manager of GMSci CMC Submission Management (CSM) manages the Global CMC Regulatory Submissions preparation for Marketing Applications (NDA, MAA, BLA, JNDA), Post-Approval Changes, and other CMC-related submissions for GMS Division by working with team members in Regulatory, Global Manufacturing Sciences subject matter experts, Quality representatives, and other contributing functions.

  • You will provide Project Management support to the submission preparation team by managing and observing timelines, and meetings.

  • You will support the submission team with operational activities in the electronic document management systems (EDMS).


How you will contribute:

  • Maintain doc plan/ timeline: Receive TOC aligned with Reg-CMC strategy; Collaborate with Reg-CMC and Content owners to prioritize and align deliverables

  • Support submission activities in Electronic Document Management Systems (EDMS): Establish/maintain document structure; Create Vdoc and applicable templates

  • Project Management Support - author management: Provide support to meetings for kickoff, roundtables, content/ data reconciliation, and follow-ups; Support Response to Questions (RTQ) process (e.g., Rapid Response Team) and Maintain content verification/ approval workflow

  • Support issue resolution and mitigation planning activities

  • Manage submission readiness: Support content verification and the final quality check (QC); Final formatting QC, uploading, check headers/ footers, linking, and folder / Vdoc structure; Work with the CMC Ancillary Documentation Management group to coordinate M1 documents

  • Support finalization and archiving of submissions: Transfer TOCs; Provide submission-ready docs for publishing; Archive necessary documents


Technical/Functional (Line) Expertise:

  • 4+ years of 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 (CTD Module 3 information and M2/QOS documents) is necessary

  • Project Management skills


Decision-making and Autonomy:

  • Skills to balance main priorities

  • A balance between customer and system/process requirements


Interaction:

  • Engage and influence team members, peers, and superiors with a collaborative working style


Innovation:

  • Support the department in all important needs and organizational goals.

  • Strength to navigate through crises


Complexity:

  • Work on submissions for biologics, plasma, chemically synthesized products, as well as devices and combination products for the entire commercial product portfolio (30+ global commercial brands)

  • Represent CMC Regulatory Submissions as a member or lead of project teams

  • Assess need, apply experience and develop solutions to complex issues and determine or negotiate the most appropriate course of action promptly


What you bring to Takeda:

Education and experience

  • Minimum BS/BA degree in Science required

  • Minimum 5 years of experience in the Pharmaceutical Industry, or relevant Regulatory environment

  • Familiarity with pharmaceutical product/process development, regulatory guidelines, and experience in regulatory submissions (in particular CTD Module 3 and M2/QOS document structure) throughout the development lifecycle


Skills

  • IT skills (Microsoft standard programs, EDMS)

  • Project Management skills


Behaviors

  • Seek input, feedback, and assessment from important partners to lead business improvements

  • Embody Takeda's leadership behaviors, coach and provide oversight on contractors and ensure resourcing of CMC submissions

  • Focus on the few priorities that matter most and provide results

  • Improve capabilities for now and the future


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

  • Professional development opportunities

  • Tuition reimbursement


Important Considerations:

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product.


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 to inspire and empowers 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.



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

Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time

Recommended Skills

  • Analytical
  • Coaching And Mentoring
  • Decision Making
  • Document Management Systems
  • Leadership
  • Pharmaceutical Development
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