Senior Manager of Regulatory Project Management and Excellence, Beijing
Senior Manager of Regulatory Project Management and Excellence, BeijingJob ID R0104105 Date posted Aug. 17, 2023 Location Beijing, China
- Co-develop and facilitate RA function all for excellence by analyzing of industry intelligence (including China NMPA, US FDA, EMA, PMDA applicable regulation and guidelines.
- Integrate and optimize LOC RA resources to build the high efficiency function.
- Provide insights on initiative, strategy and activity to facilitate effective and excellent project operations.
- Establish and ensure effective working model with internal stakeholders (global, regional, TDC, local commercial, etc.) and build the culture of partnership.
- Project specific input for execution excellence.
- Nurture innovation and solve problems creatively, commitment to excellence.
- Analyze industrial practice and find out the areas which need to be improved and provide solution.
- Support the establishment and assessment of regulatory affairs capability and development scheme.
- Streamline the working model for regulatory affairs team through the comprehensive understanding the model of collaboration functions.
- Organize/lead discussion on high frequency questions/issues, and generate action plans.
- Provide insights on RA function daily work and work out the improvement plan if needed.
- Other assigned tasks
Level of Education
Bachelor’s degree or above; Clinical medicine, life science (e.g. Chemistry, Pharmaceutics, Biochemistry, Biotechnology, Biology) or equivalent.
Working Experience in Relevant Field
Over 7 years’ experience in pharmaceutical industry or consultant firm over watching pharmaceutical industry, RA knowledge is preferred;
Strategic thinking and big picture orientation;
Professional Knowledge and Skills
Familiar with the pharmaceutical products related policy, law and regulations;
Have sense of pharmaceutical industry competitive landscape;
Excellent communication skills in Chinese and English, both verbal and written;
Expert in handling MS office (word, excel, Powerpoint etc.)
Time TypeFull time
- Job Type Full time
- Job Level Senior
- Travel Minimal
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.
- Oversee regulatory activities
- Provide strategic focus
- Collaborate cross functionally
- Ensure regulatory compliance
Where 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 start-up. 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.
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 Group and Labeling
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
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.Learn More
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.
Working at Takeda
Here, you will feel welcomed, respected, and valued as a vital contributor to our global team.
A strong, borderless team, we strive together towards our priorities and inspiring mission.
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
Recognized for our culture and way of working, we’re one of only 15 companies to receive Top Global Employer® status for 2023.
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
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- Create an exceptional people experience
- Responsibly translate science into highly innovative, life-changing medicines and vaccines
- Protect our planet
- Unleash the power of data and digital
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