Job Description
About the role:
The Regulatory Affairs, Associate Director ensures the organization gains regulatory approval for new products and product amendments, while maintaining the currency of product licenses and permits. This role helps Takeda navigate and comply with legislation and regulations, supporting the company's mission to bring better health to people and a brighter future to the world.
- Support regulatory activities related to the development, registration and lifecycle maintenance (LCM) of the Takeda vaccine candidates in the International Regions, specifically Asia Pacific (APAC) countries.
- Interact with the regulatory teams at the Local Operating Companies (LOCs) to support the development of innovative and effective regulatory strategies for initial filing and maintenance, and ensure successful execution of the defined strategy for submission, approval and commercialization of vaccine candidates.
- Provide operational and strategic input to Regional and Global cross-functional teams.
- Ensure effective communication, collaborative and constructive working relationships with all relevant stakeholders (RAV International Regions Team, LOCs, regional, Global cross-functional teams, etc.).
How you will contribute:
- Provides regulatory advice and oversight for assigned projects, focused on non-clinical and clinical aspects of vaccine development/approval and associated regulations.
- Collaborates with all Takeda regulatory counterparts to ensure alignment and execution of the global regulatory strategy for the assigned projects, for both pipeline and marketed vaccines.
- Responsible for the regulatory oversight of assigned vaccine clinical trials conducted in the region.
- Close collaboration with the RAV International Regions Head, Area Leads and LOCs to ensure alignment and regulatory strategy execution during file preparation, submission, review, approval and life cycle management.
- Identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies as applicable.
- In collaboration with the regulatory teams at LOCs, monitor the development of any new or modified regulatory requirements/guidelines which could impact vaccine regulatory activities (registration, life cycle maintenance, etc). Responsible for the communication and advice on business impact of the new regulation in the assigned region. Close alignment with Area Leads in order to ensure specifics requirements/regulations are considered in due time in VBU projects.
- Ensures compliance with both internal Takeda processes and policies as well as regional regulatory requirements.
- Supports Area Lead/International Regions Head and LOCs in the preparation of health authority/WHO meetings as applicable for specified projects.
- Actively participate as member of Global Regulatory Teams supporting products activities as assigned.
- Passion for quality in all areas of responsibility
- Leads and directs the work of others as part of a matrix organization.
Skills and qualifications:
- BS degree or equivalent in a scientific discipline, advance degree preferred.
- A minimum of 8 years of pharmaceutical industry experience in regulatory affairs, preferably in working with Emerging Markets/APAC countries.
- Strong knowledge of vaccines and/or biologics development. Regulatory experience in vaccines is essential. Experience is lifecycle maintenance activities for vaccines is a plus.
- Understands and interprets scientific issues across projects as the issues relate to regulatory requirements and strategy.
- Proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies as applicable.
- Strong in all basic skills sets such as oral and written communications (in English), managing and adhering to timelines, negotiation skills, integrity, flexibility and adaptability.
- Exceptionally strong in working and communicating well with others including global, regional and local teams as well as cross-functional teams.
- Accountable and team player.
- Fluency in English is a must.
Locations
SGP - Singapore - Emerging Markets
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Takeda Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Takeda and has not been reviewed or approved by Takeda.
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Retirement Support — Employer-funded retirement is described as notably strong, combining a dollar-for-dollar 401(k) match with an additional company contribution that scales with age and service. Access to an employee stock purchase plan further supports long-term wealth building.
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Parental & Family Support — Paid bonding leave for all parents, substantial adoption/surrogacy reimbursement, and robust caregiver resources (backup care and Maven family-forming support) are emphasized as core strengths. These offerings create a comprehensive safety net for a range of family situations.
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Healthcare Strength — Multiple medical plan options (nationwide PPO/HSA and regional HMOs), employer HSA funding, and integrated mental-health and well-being programs signal depth in coverage. Preventive care is covered in-network, and plan choices by state expand access.
Takeda Insights
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What We Do
For over 240 years, Takeda’s propensity to evolve has driven the next generation of innovation, and as a future-focused organization, we’re continuing to drive forward with endurance in our steadfast pursuit to achieve the best outcomes for our patients in a rapidly changing world. We have been preparing for this period of value creation by investing in data, digital and technology, and we’re proud of our employees and their commitment to turning groundbreaking ideas into life-changing impacts. Since our founding in Japan, integrity and putting patients first have been at the heart of our identity, and we will emerge ready for our future as one of the most trusted and science-driven digital biopharmaceutical companies. Join a team where your innovation impacts lives. Together, we’ll realize improved outcomes by improving data quality, enhancing launch execution and improving the patient journey. You’ll play a critical role in accelerating data collection and increasing accuracy across all parts of the business. Patients across the globe will benefit from access to treatments afforded by greater opportunities and efficiency in our research and development.
Why Work With Us
We connect to our history and Japanese heritage through everything we do to bring our purpose, values, vision, and imperatives to life. We are committed to bringing better health and a brighter future to patients. Being a part of Takeda means having the opportunity to be a part of something bigger than yourself.
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