返回查詢:Regulatory Lead / 台北市

At Astellas, we believe that nurturing exceptional relationships with our employees delivers exceptional business results.

Everyone at Astellas has a responsibility for creating a brighter future for patients around the world. From the first moment, Astellas will inspire you to put this ethos into practice – with a positive, agile company culture and with well-defined ethical principles, values, and systems

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 innovato

**r.

Purpose and Sco**

pe:

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 requireme

nts.

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 re

**gion.

Responsibilities and Accountabil**

  • ities: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 require
  • ments.Develop and implement regional clinical trial regulatory strategies aligned with global development objectives and time
  • lines.Provide strategic input to clinical study teams and Global/Regional Regulatory Leads (GRL/RRL) to ensure trial design, documentation, and execution meet regional regulatory expecta
  • tions.Serve as primary regulatory contact with local health authorities (e.g., TFDA) for clinical trial submissions, queries, and appr
  • ovals.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 st
  • udies.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 document
  • ation.Contribute to cross-functional initiatives to enhance regulatory efficiency, harmonize submission processes, and maintain best practices across re
  • gions.Provide mentorship and regulatory guidance to internal stakeholders on regional regulatory processes and expectations for clinical trial approvals and mainte
  • nance.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 r

egion.Required Qualific

**ations

Education and Exp**

  • erienceBachelor's or advanced degree in Life Sciences, Pharmacy, Medicine, or a related scientific disc
  • ipline.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 requir
  • ements.Experience working in cross-functional and multicultural teams within a global matrix organi
  • zation.Demonstrated ability to manage multiple projects and regulatory submissions within tight tim

**elines.

Technical and Regulator**

  • y SkillsComprehensive knowledge of local and regional clinical trial regulations, registration procedures, and regulatory systems (e.g., TFDA online p
  • ortals).Strong understanding of drug development processes and the regulatory lifecycle from early clinical development to post-marketing act
  • ivities.Ability to interpret and apply regulatory guidelines to ensure compliance and minimi
  • ze risk.Excellent document preparation and review skills with attention to scientific and regulatory a

**ccuracy.

Behavioral Com**

  • petenciesStrong communication, collaboration, and stakeholder managemen
  • t skills.Ability to influence and work effectively across functions and geo
  • graphies.High level of accountability, organization, and problem-solving ori
  • entation.Fluent in English (spoken and written); proficiency in Mandarin Chinese is

**required.

Preferred Q**

  • ualificationsDoctoral degree (MD, PhD in health-related science

**, or PharmD).

Worki**

ng 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 Flexibil

*ity Guidelines.

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from Astellas. All genuine communication will come from an official Astellas LinkedIn profile or a verified compan

*y email address.

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