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(Sr.)Manager, CMC Regulatory Affair, R&D, Shanghai/Beijing

Shanghai, China

Shanghai, China| Beijing, China

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  • Job Type: Full Time
  • Job Level: Senior
  • Travel: Minimal (if any)

Takeda has been translating science into breakthrough medicines for 240 years. Every step of the way, our teams have worked together to tackle some of the most challenging problems in drug discovery and development. Today, we’re a driving force behind innovative therapies that make a lasting difference to millions of patients around the world.

In R&D, all of our history and potential comes together in an environment that welcomes diversity of thought and amplifies every voice. Working closely with colleagues, you’ll play a key role in bringing our rich pipeline of products forward to help patients. Come join a team that’s earned trust for more than two centuries, and find out how advancing transformative therapies at Takeda will shape your bright future.

Job ID R0161139 Date posted 08/19/2025 Location Shanghai, China

Shanghai, China| Beijing, China

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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

Shanghai, ChinaBeijing, China

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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Glassdoor Reviews and Company Rating
During my 20-year journey here, I’ve been fully supported by my colleagues, and I can’t say enough about our rich internal talent and the long-standing values that drive our decisions as we work to develop important medicines for the patients we serve.

Doug Coffman - Head, R&D Asset Transition & Integration Office, R&D Regional & Business Operations

When making any type of decision, the first thing we ask is 'how will this impact patients?’ Ultimately, we’re laser focused on the best interests of the patient, and I truly believe we follow through on that.

Meredith Culp - VP, Head of Neuroscience Therapeutic Area Strategy & Operations and Head of Global Development Integration Office

Our culture and shared values make us like a family here at Takeda. It doesn't feel like work when you're doing something you love with people you love, and when your outcome is really fantastic.

Alison Handley, Head, Center for External Innovation

The heart of our work

Shining a light on new perspectives

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.

  • Integrity

  • Fairness

  • Honesty

  • Perseverance

Working at Takeda

  • 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.

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