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Takeda Pharmaceutical Company Limited
On the Global Manufacturing and Supply (GMS) team at Takeda, you’ll be part of a rapidly transforming industry that’s applying technology and data in new ways. Within our agile, innovative, people-centric organization, your work will matter every day as you use your skills to help us manufacture therapies for patients on our four platforms:
As part of the GMS team, you'll have the opportunity to pursue unique experiences and build new skills, and you'll know that the work you do every day makes an impact — on our patients, our people, our planet, and on yourself.
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Takeda Manufacturing USA, Inc. is seeking a CMC Submissions Lead in Cambridge, MA with the following requirements: Master’s degree in Pharmaceutical Sciences, Regulatory Affairs or related field plus 2 years of related experience. Prior experience must include: Knowledge of global regulatory guidelines, and understanding of Good Documentation Practices (GDP), Good Manufacturing Practices (GMP), and regulatory requirements for New Drugs; Understanding of the U.S. drug laws, FDA regulations/data expectations for pharmaceutical products, FDA standards for nonclinical testing and quality, data requirements and review process of New Drug Applications, etc.; Ability to create/maintain regulatory submission content plan, timeline, submission strategy, establish submission structure in electronic common technical document format for CMC Module 3 information; Written and oral communication skills in regard to scientific/pharmaceutical Dossiers; Ability to manage cross-functional authoring teams (lead kick-o, roundtable meetings, content/data reconciliation, verify content, functional approval). Up to 20% telecommuting allowed.
Full time. $144,500 - $186,000 per year.
Apply on-line at https://jobs.takeda.com and search for Req # R0132109.
Inclusion
Here, you will feel welcomed, respected, and valued as a vital contributor to our global team.Collaboration
A strong, borderless team, we strive together towards our priorities and inspiring mission.Innovation
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.Top Workplace
Recognized for our culture and way of working, we’re one of only 17 companies to receive Top Global Employer® status for 2024.Work-Life
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.Empowerment
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.Our values of Takeda-ism are Integrity, Fairness, Honesty and Perseverance, with Integrity as the core. These are brought to life through actions based on Patient, Trust, Reputation and Business, in that order.
Our belief in putting people first extends beyond our patients — it includes their families and communities, as well as our Takeda colleagues and their families.
We are committed to embracing our differences, valuing different perspectives, and fostering a culture of respect, inclusiveness and empowerment.
Our embedded Diversity, Equity & Inclusion (DE&I) strategy enables us to attract and retain exceptional talent, drives innovation, and helps address systemic inequalities in our communities.
Integrity
Fairness
Honesty
Perseverance
Patient
Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.
People
Create an exceptional people experience.
Planet
Protect our planet.
Data & Digital
Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.
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