Manager, China CMC Regulatory Affairs
Beijing, Beijing Municipality- 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
RESPONSIBILITIES:
* Develop and execute global regulatory strategies for assigned programs
* Collaborate with regional counterparts to compile and align global regulatory strategies
* Create and submit high-quality, compliant regulatory documents within defined timelines
* Manage regulatory submissions and maintain compliance for assigned programs
* Support health authority interactions and meetings related to assigned programs
* Ensure accurate, up-to-date reporting of program status and milestones globally
* Lead and mentor junior staff, enhancing team capabilities
R&D Qualifications & Skills:
* Expertise in developing regulatory strategies and a deep understanding of CMC requirements
* Proven ability to negotiate with and influence health authorities
* Strong leadership skills, capable of managing and directing project teams
* Effective at working across functions to align strategies and achieve objectives
* Skilled in managing regulatory submissions and maintaining compliance
* Excellent communication skills, able to clearly convey complex information
* Proficient in mentoring and developing junior staff, enhancing team capabilities
* Capable of identifying and mitigating risks in regulatory strategies and operations
Locations
Beijing, ChinaWorker 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. -
Great Place to Work
Recognized for our culture and ways of working, we’re proud to be Certified as a Great Place to Work® in 25 countries and regions. -
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.
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