Job Description: Regulatory Specialist Location: Home-based anywhere in Taiwan Position Overview: The Regulatory Specialist will play a key role in ensuring clinical research projects comply with local and global regulatory requirements.

This individual will be responsible for preparing, reviewing, and submitting essential regulatory documentation to ensure smooth project execution and adherence to applicable laws, guidelines, and industry standards.

Key Responsibilities: Regulatory Submissions and Compliance: Prepare, review, and submit regulatory documents to Ethics Committees (ECs), Institutional Review Boards (IRBs), and Competent Authorities as required.

Ensure timely approval of regulatory submissions to meet project timelines.

Maintain up-to-date knowledge of global and local regulatory requirements and guidelines (e.g., ICH-GCP, FDA, EMA, TGA, etc.).

Documentation and Records Management: Maintain accurate records of submissions and approvals.

Ensure proper documentation of correspondence with regulatory authorities and study stakeholders.

Project Support: Collaborate with cross-functional teams, including clinical operations, project management, and data management, to ensure compliance across all aspects of the study.

Provide regulatory guidance and training to project teams as needed.

Risk Management: Identify potential regulatory risks and develop mitigation strategies.

Ensure corrective and preventive actions are implemented for non-compliance issues.

Stakeholder Communication: Serve as the primary point of contact with regulatory authorities.

Foster strong relationships with clients, ensuring their needs are met in the context of regulatory compliance.

Qualifications and Experience: Education: Bachelor’s degree in a relevant field (e.g., life sciences, pharmacy, or related discipline).

Experience: Minimum of 2-5 years of experience in regulatory affairs within the clinical research or pharmaceutical industry.

Strong understanding of clinical trial processes and regulatory frameworks.

Skills: Excellent attention to detail and organizational skills.

Strong written and verbal communication abilities.

Ability to work independently and collaboratively within a team.

Proficiency in MS Office Suite and regulatory submission platforms.

Preferred Qualifications: Experience with international regulatory submissions.

Certification in Regulatory Affairs (RAC) or equivalent.

Familiarity with electronic Trial Master Files (e TMF) and regulatory tracking systems.

To Apply: Please submit your CV before closing date of 15 Jan2025.