Director of FDA Regulatory Affairs (Biotech Consultant)
Company Overview
TECQMIND is an end-to-end AI professional services and staffing partner focused on the "how." In the Biotech sector, we act as a strategic bridge between world-class Taiwan-based technology partners and the United States market. We provide the specialized talent and regulatory oversight required to turn global innovations into FDA-approved realities.
The Role
As the Director of FDA Regulatory Affairs, you will be the strategic lead responsible for guiding Taiwan-based biotech companies through the complexities of the US FDA landscape. You will translate client R&D and clinical data into successful regulatory submissions, acting as the primary liaison between our international partners and US regulatory bodies.
This is a contract position where the candidate will be hired by TECQMIND to serve as a high-level regulatory advisor for our specialized biotech clients.
Key Responsibilities
Regulatory Strategy & Roadmapping: Develop and execute comprehensive FDA regulatory strategies for a variety of assets (Small Molecules, Biologics, or Medical Devices/AI-Diagnostics).
Submission Management: Lead the preparation and filing of key regulatory documents, including Pre-IND, IND, NDA, BLA, or 510(k) submissions.
FDA Liaison: Act as the official point of contact for the FDA; lead formal meetings, respond to "Requests for Information" (RFIs), and manage inspections.
Compliance Oversight: Review clinical trial protocols, CMC (Chemistry, Manufacturing, and Controls) documentation, and labeling to ensure 100% alignment with FDA Code of Federal Regulations (CFR).
Gap Analysis: Conduct deep-dive audits of Taiwan-based R&D data to identify and remediate "regulatory gaps" before they become bottlenecks in the US market.
Global Synchronization: Work closely with the client’s Taiwan-based R&D and quality teams to ensure that international manufacturing and laboratory practices meet US GLP/GMP/GCP standards.
Required Qualifications
Experience: 10+ years of professional experience in Regulatory Affairs within the US Biotech or Pharmaceutical industry.
Proven Track Record: A documented history of successful FDA approvals (INDs, NDAs, or BLAs) and positive outcomes in formal FDA meetings.
Regulatory Depth: Mastery of FDA regulations across CDER (drugs) and/or CBER (biologics). Experience with CDRH (devices/AI-software) is a major plus.
Education: A Master’s or Ph.D. in a Life Sciences or Legal field. RAC (Regulatory Affairs Certification) is highly preferred.
Communication: Exceptional ability to explain complex US regulatory requirements to international stakeholders who may be unfamiliar with the US legal landscape.
Highly Desired: Preferred Qualifications
Bilingual Proficiency: Professional fluency in English and Mandarin (written and verbal). This is a massive advantage for facilitating direct, nuance-heavy discussions with scientific leads and executives in Taiwan.
Digital Health Expertise: Experience navigating the FDA’s "Digital Health Software Pre-certification Program" or AI-specific regulatory pathways.
Contracting Experience: Previous experience as a consultant or fractional lead for international firms entering the US market.