Regulatory Affairs Manager
Taipei, Taiwan Job ID R0111097 Category Research & Development Subcategory Research & Development Business Unit Global Portfolio Division Job Type Full timeBy 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:
To handle registration administration processes on the assigned project(s) of
responsibility in order to ensure product lifecycle management timely and properly
and comply with internal and external regulatory requirements.
ACCOUNTABILITIES:
1) To be responsible for regulatory submissions (NDA) for product
registration, line extension, product variation, post- market approval
change, license maintenance etc.
2) New plant master file (PMF) registration and maintenance in line
with requirements of local regulation.
3) Execute and lead the assigned project to ensure compliance with
domestic directives as well as government regulations.
4) Provide regulatory services to business unit to ensure early assess
of new products as well as hospital listing.
5) Handle toll manufacturing projects with related change in line with
government requirements.
6) To maintain current knowledge base of existing and emerging
regulations standards or guidance documents in order to update
company on new regulations/new procedures.
7) To prepare or maintain technical files as necessary in order to obtain
and sustain ethical product approval.
QUALIFICATIONS:
1. Degree in Medical/Science, pharmacist preferable
2. Familiar with pharma. regulation, at least 4+ years of RA experience in
multinational company / Pharma. industry.
3. Aggressive, independent, well organized, willing to work under pressure, good
communication, coordination and interpersonal skill, good command of English and local language
TRAVEL REQUIREMENTS:
Occasional local travel required (10%)
Locations
Taipei, TaiwanWorker Type
EmployeeWorker Sub-Type
RegularTime Type
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Global Regulatory Affairs – Plasma Derived Therapies Plasma-derived therapies are critical, life-saving medicines that thousands of people with rare and complex diseases rely on every day around the world. The Plasma Derived Therapies Business Unit within Takeda focuses on reimagining plasma and going beyond incremental improvements to find a wide range of innovative and sustainable solutions to serve patients better. November 13, 2023 Life at Takeda Related Content Fellowships
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Career Growth: Waqas Younus Career growth at Takeda featuring Waqas Younus. Waqas underscores the paramount importance of self-directed learning and maintaining a mindset geared towards continual growth. January 10, 2024 Life at Takeda Employee Spotlight Learning & Development
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Takeda Continues as a Global Top Employer Celebrating Seven Years of Excellence We are thrilled to announce our seventh consecutive recognition as a global Top Employer® for the year 2024. Awarded by the esteemed Top Employers Institute, this prestigious certification underscores our steadfast commitment to cultivating an exceptional work environment for our employees worldwide. January 11, 2024 Life at Takeda Related Content Business Overview Learning & Development
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DEI Clinical Advisory Board Our Advisory Board is one of many ways we’re incorporating a DE&I agenda not just with our people, but with the patients who rely on our treatments. We're committed to a long-term journey of change in processes, policies, and mindsets. December 14, 2023 Life at Takeda Related Content Diversity, Equity, & Inclusion
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Unlocking Innovation: A Glimpse into Takeda's Innovation Capability Centers (ICCs) At the heart of our commitment to driving global digital transformation are its Innovation Capability Centers (ICCs). These centers serve as dynamic hubs where diverse talents from various backgrounds and countries come together to shape the future of healthcare. January 08, 2024 Life at Takeda Related Content Employee Spotlight Innovation Our Manufacturing Facilities
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Innovation, Mistakes and Psychological Safety: How Takeda Fosters a Growth MindsetInnovation, Mistakes and Psychological Safety: How Takeda Fosters a Growth Mindset Innovation comes from mistakes. Our Chief Talent Officer at Takeda, Stephen Dwight, shares how psychological safety and a growth mindset are key to driving innovation in our organization. January 19, 2024 Life at Takeda Related Content Employee Spotlight
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Employee Spotlight: Siew Hoo Learn about Siew Hoo, senior manufacturing manager, and his accomplishments, experiences, and overall career journey. January 23, 2024 Life at Takeda Related Content Employee Spotlight
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Employee Spotlight: Molly Silsby Discover Molly's unique career journey in engineering through the Operations Development Program. November 10, 2023 Life at Takeda Related Content Employee Spotlight
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Takeda Resource Group: EnAbles EnAbles envisions an accessible workplace where all have the opportunity to realize their potential, unencumbered by barriers. We serve team members living with physical, sensory or cognitive impairment whether personally, through a loved one or as an ally. February 12, 2024 Life at Takeda Related Content Diversity, Equity, & Inclusion
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Takeda Resource Group: Mosaic MOSAIC believes that our global, hybrid, multicultural and multilingual workforce enriches our daily lives. It expands our views of the world to be able to look at things differently and provides an opportunity to grow. February 12, 2024 Life at Takeda Related Content Diversity, Equity, & Inclusion
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Takeda Resource Group: PACT PACT (Parents & Caregivers at Takeda) creates an inclusive community which seeks to provide opportunities for members to exchange ideas, resources, and experiences, and provide Takeda with an internal resource for feedback on corporate initiatives and practices that impact working parents and caregivers. February 12, 2024 Life at Takeda Related Content Diversity, Equity, & Inclusion
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Takeda ranks 2023 Best Places to Work for LGBTQ+ Employees For the seventh consecutive year, Takeda earned a perfect score on the Human Rights Campaign's (HRC) Corporate Equality Index (CEI) and is proud to be named as one of the 2023 Best Places to Work for Lesbian, Gay, Bisexual, Transgender & Queer (LGBTQ+) Equality. February 16, 2024 Life at Takeda Related Content Diversity, Equity, & Inclusion
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Career Growth: Rola Noueiha Embarking on a career journey with us has been a transformative experience for Rola Noueihed. Initially starting in finance HR, Rola gradually shifted her focus to support various functions within the company. February 08, 2024 Life at Takeda Related Content Business Overview Employee Spotlight
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Career Growth: Doug Coffman Your career should be more than a job—it should be your haven of belonging, infusing daily life with excitement and offering a path to harmonious work-life alignment. For Doug Coffman, Takeda has offered him just that. February 08, 2024 Life at Takeda Related Content Business Overview Employee Spotlight
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Learn About Takeda in Osaka The Osaka Site is the birthplace of Takeda, evolving from a small market stall to being part of Takeda's Global Manufacturing and Supply Division (GMS), manufacturing injectables as one of the world's key manufacturing sites. November 23, 2023 Life at Takeda Related Content Location Our Manufacturing Facilities
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Career Growth: Olga Frolova Olga Frolova's career at Takeda is a perfect example of how dedication, mentorship, and a positive attitude toward growth can help transform one's professional journey. Initially employed as an assistant in the regulatory department, Olga demonstrated a strong commitment to her career aspirations from the very beginning. She seized every opportunity to learn and make valuable contributions toward the success of the organization. February 21, 2024 Life at Takeda Related Content Business Overview Employee Spotlight
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Employee Spotlight: Julien Janda Learn more about Julien's career journey to becoming head of process & technology, in addition to navigating the wonders of fatherhood. February 09, 2024 Life at Takeda Related Content Employee Spotlight
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Employee Spotlight: Yvonne Burazer Learn more about Yvonne's career journey within Global Engineering as a global power user and her biggest rewards and achievements. February 06, 2024 Life at Takeda Related Content Employee Spotlight
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Takeda Engages with Students at the Zurich Life Science Day The Zurich Life Science Day – the largest career fair for Life Sciences in Switzerland with nearly 1000 participants from top local universities – saw on February 6, 2024 the active participation of Takeda, emphasizing the importance of engaging with prospective talent at an early stage in their professional development. March 11, 2024 Life at Takeda Related Content Community Involvement
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Jaguariuna Manufacturing Facility Learn more about our Jaguariuna site which is supported by 700 employees across different areas dedicated to Quality, Manufacturing, Engineering, Environmental Health & Safety, Business Excellence, Manufacturing & Science, and more. February 21, 2024 Life at Takeda Related Content Location Our Manufacturing Facilities
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Career Growth: Gundula Schneidewind Each of our team members weaves a unique narrative into our rich history. This month, we spotlight Gundula Schneidewind, Head of our GI Business Unit in Germany, whose journey at Takeda reveals a harmonious blend of purpose, collaboration and a balanced life-work alignment. March 04, 2024 Life at Takeda Related Content Employee Spotlight
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