China Regulatory Affairs CMC Manager

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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, support the development and implementation of China CMC regulatory investigation, registration and post approval strategies for localized projects. Support Global Regulatory CMC, Global Regulatory, manufacturing site and Commercial project teams for assigned products.

2.Develops a solid understanding of RA CMC regulations and guidelines, and support the development of strategies to enhance probability of regulatory success and regulatory compliance.

3.Interacts and effectively communicates with other internal and external colleagues.

4.With minimal supervision, executes and manages regulatory submission for assigned projects.

5.With supervision, prepares CMC submission dossier, helps define CMC content requirements, ensure high quality CMC submission complying with external and internal requirement.

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

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

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

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

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

What you bring to Takeda:

1.BS/BA Degree required with 3+ years of relevant Industry, academic or HA experience; advanced degree preferred.

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

3.Experience with localized products is preferred.

4.Ability to understand, apply and articulate 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.

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