Senior Manager of Regulatory Project Management and Excellence, Beijing
Beijing, China
Senior Manager of Regulatory Project Management and Excellence, Beijing
Job ID R0104105 Date posted Aug. 17, 2023 Location Beijing, ChinaBy clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
OBJECTIVE
- 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.
ACCOUNTABILITIES
- 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
QUALIFICATIONS
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.)
Locations
Beijing, ChinaWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full 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.
Our Pipeline
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 MoreWhat 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 15 companies to receive Top Global Employer® status for 2023.
-
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.
View All Regulatory Affairs Jobs
Search-
Sr. Manager, Global Labeling (REMOTE)
Georgia, Remote Regulatory Affairs Apply for Sr. Manager, Global Labeling (REMOTE) -
US Lead, Global Regulatory Policy & Innovation
Boston, Massachusetts, Remote Regulatory Affairs Apply for US Lead, Global Regulatory Policy & Innovation -
Director, Global Regulatory Affairs CMC- Cell & Gene Therapy
Boston, Massachusetts, Remote Regulatory Affairs Apply for Director, Global Regulatory Affairs CMC- Cell & Gene Therapy
Related Content
We Take Action by Focusing on Our Four Priorities
- 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
Job Alerts
Would you like to receive relevant opportunities in your inbox as soon as they’re posted?
SIGN UPTalent Network
Are you interested in company news, attending career events, and hearing more from Takeda?
JoinBy submitting your information, you acknowledge that you have read our privacy policy and consent to receive email communication from Takeda Pharmaceuticals.