Manager, Global Regulatory Affairs CMC Submissions Management
Lexington, Massachusetts- Job Type: Full Time
- Job Level: Senior
- Travel: Minimal (if any)
Global Regulatory Affairs (GRA) develops and executes innovative regulatory strategies to provide life-changing therapies to patients. GRA has a strategic role in all stages of global product development and across the Takeda Enterprise.
At Takeda, we strive to provide transformational opportunities for every member of our team, and we empower our people to take charge of their futures. In an environment that fosters lifelong learning and a growth mindset, you’ll have the support you need to thrive — at work and beyond.
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Job Description
Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC Submissions Management in Lexington, MA with the following requirements: Bachelor’s degree in a scientific field or foreign academic equivalent plus 4 years of related experience. Required skills: Ability to work with firm deadlines and adapt quickly to changing requirements and priorities; develop/maintain strong working relationships with the regulatory CMC team and cross-functional teams, participate on and/or lead multifunctional teams, handle and prioritize multiple projects and work independently; experience with global CMC regulations for advanced therapies and biological compounds; knowledge of worldwide CMC regulatory requirements and successful track record of delivering dossiers that comply with these, particularly for new medicines in development. Up to 20% domestic travel required. Up to 50% remote work allowed.
Full time. $178,500 - $202,000 per year.
Apply on-line at https://jobs.takeda.com and search for Req #R0133816.
Locations
Lexington, MAWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeWhere you fit in
When you join our Regulatory Affairs team, you’ll help ensure the fastest, safest path for our treatments to get to patients. With colleagues who encourage you to question everything for better outcomes, you’ll be part of a team that’s deeply involved across each therapeutic area, from candidate selection to post-marketing.
At Takeda, you’ll join an environment with the energy and flexibility of a startup. We continue building on our 240-year history as a global biopharmaceutical leader through our innovative mindset and lean governance. Find everything you need on our Regulatory Affairs team to positively impact patients’ lives while taking strides within your own.
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Oversee regulatory activities
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Provide strategic focus
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Collaborate cross functionally
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Ensure regulatory compliance
Integrity is at the center of everything we do. This value is not something that you teach — it comes with the package.
Tatiana Ishida - Head of Global Regulatory Affairs, Marketed Products Development, Labeling and Advertising & Promotion
We sit outside of the traditional disciplines, so we’re able to get involved in everything.Our role is to distill complex information and pull insights that give us a competitive advantage.
Nahid Latif - Head, Global Regulatory Affairs
The heart of our work
Shining a light on new perspectives
Our pipeline
Our internal research capabilities and external partnerships contribute to an R&D engine that has produced exciting new molecular entities (NMEs) across our core Therapeutic Areas. Check out our pipeline and see how we’ll continue delivering a steady stream of next-generation therapies.
What we believe in
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.
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Integrity
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Fairness
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Honesty
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Perseverance
Working at Takeda
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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.
We're Steadfast In Our Commitment to Four Key Imperatives
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.
Related Content
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Global Top Employer 2024 Takeda named Global Top Employer for seventh consecutive year. -
How we partner Explore more. -
Takeda’s Global CSR Program Explore more.
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