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:
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
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
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.
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.
- Coaching And Mentoring
- Decision Making
- Document Management Systems
- Pharmaceutical Development