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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US Medical and Scientific Communications Fellowship The fellow will have the opportunity to experience, collaborate with, and receive individual mentorship from various functions within US Medical and Scientific Communications, as part of a one-year fellowship program. October 26, 2023
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US Medical and Field Medical Fellowship The fellow will have the opportunity to experience, collaborate with and receive individual mentorship from the in-house and field-based groups within US Medical. October 26, 2023
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Takeda Resource Group: Take Pride Take Pride serves as a visible and accessible resource for all Takeda employees regardless of sexual orientation or gender identity to ensure that Takeda's LGBTQ employees and allies feel safe, respected, and supported. October 26, 2023
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Takeda named in Human Rights Campaign Best Places to Work for LGBTQA+ For the sixth consecutive year, Takeda has earned a perfect score of 100 on the Human Rights Campaign's Corporate Equality Index October 26, 2023
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Research and Development At Takeda R&D, we do more for patients by translating science into highly innovative, life-changing medicines across our core Therapeutic Areas in Innovative Biopharma. October 02, 2023
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Lessines, Belgium Manufacturing Facility Learn about our Manufacturing Facility in Belgium The Lessines manufacturing site in Belgium is responsible for Takeda’s production of plasma-based therapies. With a 75+ year pioneering legacy in producing plasma-derived therapies, and as a leader in rare diseases, Takeda is well-established as a top three global player and has an excellent portfolio of plasma-derived products. The Lessines site has been in operation for over 50 years and specializes in immunoglobulin (IG) used for plasma-derived therapies to treat rare and complex chronic diseases. December 12, 2024
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Takeda Gastrointestinal & Inflammation Clinical Sciences Fellowship Takeda Gastrointestinal & Inflammation Clinical Sciences is an industry leader in advancing science to help bring medicines to patients with gastrointestinal, inflammatory and liver diseases. Fellows will have the opportunity to contribute to high-impact drug development programs from Phase 1 to Phase 3 clinical trials. November 13, 2023
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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
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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
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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
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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
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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
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Innovation Capability Center The Innovation Capability Center (ICC) is an organization focused on delivering innovative solutions to enable Takeda's data and digital transformation, building future skills in-house, and is an internal innovation muscle. March 05, 2024
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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
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Our Sustainability Commitment Taking care of patients is about more than developing life-transforming treatments. It’s about being responsible, ethical and protecting the planet we share, too. We must do our part to continually reduce our environmental impact and put environmental stewardship and resource conservation at the heart of our business operations and practices. March 27, 2024
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Takeda’s Benefits Selected With Care: Supporting Whole-Family Health For Working Parents And Caregivers In pursuit of our purpose, we put people first. By listening to our employees, we create an exceptional people experience to offer the best whole-family health benefits and resources our employees want the most. Here’s what’s new. August 30, 2024
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Career Moves: Filippo Ramondelli Discover career growth, learning and development stories in our Career Moves series. September 20, 2024
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Career Moves: Helen Grad Discover career growth, learning and development stories in our Career Moves series. September 20, 2024
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Career Moves: Averil Lee Neng Discover career growth, learning and development stories in our Career Moves series. September 26, 2024
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Careers with Purpose: Amplifying Employee Passions and Patient Voices Our dedication to driving impact for patients includes understanding healthcare inequities in the communities we serve. Inspired by our vision, each person’s contributions here help us do better for patients. Our patient speaker series, La Voz is one example. September 27, 2024
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Pioneers Of Change: Shaping The Future Together Through Our IMPACTO Takeda Resource Group In celebration of Hispanic Heritage Month, discover how our IMPACTO Takeda Resource Group fosters unity and inclusivity to shape a diverse future. October 10, 2024
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Global Medical Information & Review Fellowship The objective of this program is to provide the fellow with opportunities to develop core competencies in both Medical Information and Medical Review. October 09, 2023
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