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Everything we do is lead by our company values of integrity, being patient centric, taking ownership, delivering results, and communicating openly. These values are essential to Astellas relationship with its employees and now is an exciting time to join us as we continue to evolve as a cutting-edge, value-driven life sciences innovator.
Purpose and Scope
The Regulatory Affairs Lead Clinical Trials is responsible for the development and implementation of regulatory strategies, plans, and processes to support the successful authorization and conduct of assigned clinical trials. The role ensures that regulatory activities are executed in alignment with global development objectives, corporate standards, and applicable regional requirements.
This position serves as the regional regulatory representative within study teams, responsible for obtaining and maintaining clinical trial authorizations for compounds in development or marketed products under investigation for new indications. While the primary focus is on Taiwan, the role may also provide regulatory support for clinical trials in other countries within the Asia-Pacific region.
Responsibilities and Accountabilities:
- Lead the preparation, submission, and maintenance of Clinical Trial Applications (CTAs) and Investigational New Drug (IND) applications in Taiwan, ensuring full compliance with local and global regulatory requirements.
- Develop and implement regional clinical trial regulatory strategies aligned with global development objectives and timelines.
- Provide strategic input to clinical study teams and Global/Regional Regulatory Leads (GRL/RRL) to ensure trial design, documentation, and execution meet regional regulatory expectations.
- Serve as primary regulatory contact with local health authorities (e.g., TFDA) for clinical trial submissions, queries, and approvals.
- Collaborate closely with the Clinical Trial Unit RA, Early Development, Clinical Operations, and Global Regulatory Affairs to ensure timely submissions, approvals, and updates for ongoing clinical studies.
- Prepare, review, and ensure the quality, scientific integrity, and regulatory compliance of technical and administrative documentation supporting CTAs/INDs.
- Monitor and interpret changes in clinical trial regulations, guidelines, and regulatory trends in Taiwan, and proactively communicate implications to project teams.
- Support regulatory inspections, audits, and compliance activities related to clinical trial conduct and documentation.
- Contribute to cross-functional initiatives to enhance regulatory efficiency, harmonize submission processes, and maintain best practices across regions.
- Provide mentorship and regulatory guidance to internal stakeholders on regional regulatory processes and expectations for clinical trial approvals and maintenance.
- As agreed with regional or global regulatory management, may provide support for clinical trial submissions and maintenance activities in other countries within the Asia-Pacific region.
Required Qualifications
Education and Experience
- Bachelor's or advanced degree in Life Sciences, Pharmacy, Medicine, or a related scientific discipline.
- Minimum 4 years of experience in Regulatory Affairs within the pharmaceutical or biotechnology industry, with a strong focus on clinical trial applications (CTAs/INDs).
- Proven experience preparing, submitting, and maintaining clinical trial authorizations in Taiwan (TFDA).
- Solid understanding of global regulatory frameworks (ICH-GCP, GMP, TFDA IND process) and their application to regional clinical trial requirements.
- Experience working in cross-functional and multicultural teams within a global matrix organization.
- Demonstrated ability to manage multiple projects and regulatory submissions within tight timelines.
Technical and Regulatory Skills
- Comprehensive knowledge of local and regional clinical trial regulations, registration procedures, and regulatory systems (e.g., TFDA online portals).
- Strong understanding of drug development processes and the regulatory lifecycle from early clinical development to post-marketing activities.
- Ability to interpret and apply regulatory guidelines to ensure compliance and minimize risk.
- Excellent document preparation and review skills with attention to scientific and regulatory accuracy.
Behavioural Competencies
- Strong communication, collaboration, and stakeholder management skills.
- Ability to influence and work effectively across functions and geographies.
- High level of accountability, organization, and problem-solving orientation.
- Fluent in English (spoken and written); proficiency in Mandarin Chinese is required.
Working Environment
At Astellas we recognize the importance of work/life balance and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas Responsible Flexibility Guidelines.
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