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China Regulatory Affairs CMC Manager

Tianjin, Tianjin Municipality
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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:

  • Small Molecules
  • Biologics
  • Plasma
  • Cell and Gene

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.

Job ID R0115386 Date posted 01/17/2024 Location Tianjin, Tianjin Municipality

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Job Description

Job Title: China Regulatory Affairs CMC Manager

Location: Tianjin, China

About Takeda:

天津武田药品有限公司是一家全球化发展的外资制造型企业。我们始终践行着对于患者和社会的承诺,并致力于在医药领域做出更加卓越的贡献。

How you will contribute:

1.With supervision, executes regulatory submission for assigned projects.

2.With supervision, prepares CMC submission dossier, support communication of CMC content requirements, ensure high quality CMC submission complying with external and internal requirement.

3.With supervision, participates Health Authority interactions and support CMC consultation meetings preparation with Health Authority on CMC related matters.

4.With supervision, handle sample registration testing in NIFDC/IDC, to support related registration approval.

5.With supervision, support Health Authority on-site inspection on CMC RA related matters.

6.Ensure line management is apprised of developments that may impact regulatory success, communicating in professional and timely manner.

7.Ensure compliance with all applicable Takeda SOPs, and local and international regulations.

What you bring to Takeda:

1.BS/BA Degree required with 2+ years of relevant Industry, academic or HA experience; advanced degree preferred

2.Experience with CMC development or regulatory, or equivalent industry experience.

3.Experience with localized products is preferred.

4.Ability to understand and apply regulatory CMC requirements for drug development and post-market support initiatives required.

5.Demonstrates attention to detail and problem-solving abilities.

6.Exercise appropriate judgement when working with project teams.

7.Excises good judgement in elevating and communicating actual or potential issues to line management.

8.Excellent written and oral communication skills required.

9.Written and oral communication in English is required.

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 that will inspire and empower 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.

Empowering our people to shine:

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.

Locations

Tianjin, China

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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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.

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

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.

Exterior of Takeda Building

About our location

Tianjin, Tianjin Municipality


View Map of Tianjin, Tianjin Municipality

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