RA Operations Associate Manager
Beijing, Beijing Municipality- 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.
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Job Description
Objective / Purpose:
Ensure RA operation support for New and Marketed products. Keep close contact with local and global stakeholders and cooperate to RA operation and compliance.
Accountabilities:
Support RA dossier verification check, publishing, submission and archiving. Lead system integration and implementation in China RA, not limited to regulatory information management system (MEDIVA), EDMS. Product artwork system management, including label/PI double confirmation. RA SOP management and SOP training monitoring. Local Regulatory compliance support for RA team, perform gap assessment represent from China RA. Operation support for product IP, timeline update, product registration news, RA access account etc. Other assigned work from line manager
Education & Competencies (Technical and Behavioral):
- Level of Education: Bachelor’s degree or above
- Working Experience in Relevant Field: >=4-year related work experience
- Professional Knowledge and Skills: Excellent communication skills, both verbal and written. Proficiency in English is a must. Skilled in using computer office software; Good skills in English listening, speaking, reading, and writing; Be familiar with the laws and regulations on drug administration and registration management, with stronger communication skills and professional competence.
Locations
Beijing, ChinaWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeThe heart of our work
Shining a light on new perspectives
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 2025. -
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.
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Protect our planet.
Data & Digital
Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.
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