Regulatory Affairs Specialist
Takeda Pharmaceutical Company Limited
Job Details
Regulatory Affairs Specialist
Kyiv, Kyiv City Job ID R0138482 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
Job Title: Regulatory Affairs Specialist
Location: Kyiv, Ukraine
About the role:
Are you looking for a patient-focused, innovation-driven company that will inspire you and support your career? If so, be empowered to take charge of your future in Takeda. Join us as a Regulatory Affairs Specialist.
Takeda is a global pharmaceutical leader with more than 31,000 professionals working together across 70 countries. We have an unwavering dedication to put people first and we live our values of Takeda-ism—Integrity, Fairness, Honesty, and Perseverance. We are united by our 235-year legacy of research-based pharmaceuticals and our mission to strive toward Better Health and a Brighter Future for people worldwide through leading innovation in medicine.
How you will contribute:
As Regulatory Affairs Specialist you will be responsible for Maintenance of Regulatory Activities.
Key Responsibilities:
- Assess the dossiers for registrations, renewals, variations of the products in accordance with the Ukrainian, Moldavian and Belarusian legislation requirements.
- Maintain registration procedures (including, request of the documents, preparation of the documents for the submission, development of local documents, working with Regulatory Authority from submission to issuance of final approvals).
- Communicate with the global RA/manufacturers within satisfying additional requests and comments of the regulatory authorities.
- Perform GMP recognition procedures (including, request of documents, checking for compliance with the requirements of the Legislation, preparation of documents for submission, development of local documents, communication with government authorities).
- Collaborate with the internal stakeholders concerning the timelines of regulatory activities in order to insure uninterrupted supply of the products and launch of new products.
- Develop RA SOPs.
- Create and approve packaging materials.
Critical Skills and Competencies
- Co-operation and teamwork.
- Ability to proactively face and solve potential or actual problems.
- Attentive to details.
- Good internal and external communicator.
- Ability to deal with complexity.
- Results oriented.
- Sociability, systematic, attentiveness, punctuality.
- The ability to work under pressure and to strict deadlines
What you bring to Takeda:
Experience and Education
- Ideally have at least 2 years of experience in the same position.
- Higher education (pharmaceutical, medical, biological).
- Knowledge of medicines registration legislation (Ukraine, Moldova, Belarus).
- Ability to build productive partnership with different external and internal stakeholders.
- Fluent Ukrainian and Russian, English not lower than Intermediate.
What Takeda Can Offer You:
To further support and inspire our employees, our benefits include:
- Corporate Flexible Benefits program (annual bonus, long term incentive)
- Meal allowance, flexible hours
- Comprehensive health and life insurance
- Exposure to working in an inclusive and diverse workforce
- Tremendous exposure and learning across a wide geography
- Training and Developmental opportunities
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Empowering our people to shine:
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Locations
Kiev, UkraineWorker Type
EmployeeWorker Sub-Type
Fixed Term (Fixed Term)Time 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- Employee Spotlight: Robin Kim Learn about Robin Kim and his multifaceted career journey to head of supply chain at Takeda, Singapore Manufacturing site. May 06, 2024 Life at Takeda Employee Spotlight
- Why interns Boomerang: insights from those who came back When interns test drive their careers at Takeda, they get more than they bargain for. In pursuit of new possibilities for patients – and opportunities to gain experience – select interns return here; we call them Boomerangs. Our summer internship programs enable interns to envision a future dedicated to making history and changing the future of healthcare, over the course of 12 weeks. These are the stories of emerging female leaders who returned, to make our shared values go even further. August 06, 2024 Life at Takeda Related Content Employee Spotlight Internships Learning & Development
- 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 Life at Takeda Related Content Diversity, Equity, & Inclusion
- 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 Life at Takeda Related Content Diversity, Equity, & Inclusion Employee Spotlight
- 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 Life at Takeda Related Content Diversity, Equity, & Inclusion Employee Spotlight
- Revolutionizing Patient Treatments Through Biologics January 05, 2024 Life at Takeda Business Overview
- Career Moves: Caroline Slomski Discover career growth, learning and development stories in our Career Moves series. January 25, 2024 Life at Takeda Related Content Employee Spotlight Learning & Development
- Career Moves: Lindsey Daniel Discover career growth, learning and development stories in our Career Moves series. May 20, 2024 Life at Takeda Related Content Employee Spotlight Learning & Development
- Career Moves: Mohamed Galal Discover career growth, learning and development stories in our Career Moves series. March 26, 2024 Life at Takeda Related Content Employee Spotlight Learning & Development
- Career Moves: Career Growth at Takeda Discover career growth and learning & development stories in our Career Moves series. November 30, 2023 Life at Takeda Related Content Learning & Development
- Career Growth at Takeda Explore Takeda's career growth philosophy, and how learning and development benefits employees. July 31, 2024 Life at Takeda Related Content Learning & Development
- Career Moves: Sarah Bryant Discover career growth, learning and development stories in our Career Moves series. April 15, 2024 Life at Takeda Related Content Employee Spotlight Learning & Development
- Career Moves: Mosaad Awad Discover career growth, learning and development stories in our Career Moves series. April 24, 2024 Life at Takeda Related Content Employee Spotlight Learning & Development
- Career Moves: Averil Lee Neng Discover career growth, learning and development stories in our Career Moves series. September 26, 2024 Life at Takeda Related Content Employee Spotlight Learning & Development
- Career Moves: Christian Stirnimann Discover career growth, learning and development stories in our Career Moves series. July 09, 2024 Life at Takeda Related Content Employee Spotlight Learning & Development
- 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 Life at Takeda Related Content Our Manufacturing Facilities
- Career Moves: Maria Alvarez Discover career growth, learning and development stories in our Career Moves series. July 09, 2024 Life at Takeda Related Content Employee Spotlight Learning & Development
- Career Moves: Helen Grad Discover career growth, learning and development stories in our Career Moves series. September 20, 2024 Life at Takeda Related Content Employee Spotlight Learning & Development
- Career Moves: Filippo Ramondelli Discover career growth, learning and development stories in our Career Moves series. September 20, 2024 Life at Takeda Related Content Employee Spotlight Learning & Development
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