Regulatory and Site Start Up Specialist (Clinical Research)

TL;DR

Regulatory and Site Start Up Specialist (Clinical Research): Managing site activation readiness and preparing regulatory submission dossiers for clinical trials with an accent on compliance with international and local regulations. Focus on coordinating with Ethics Committees and Competent Authorities, mitigating site activation risks, and ensuring TMF audit readiness.

Location: Remote, Taiwan

Company

hirify.global is a Clinical Research Organization specializing in precision medicine for rare diseases and oncology.

What you will do

• Prepare and submit Clinical Trial Application forms and dossiers to Competent Authorities and Ethics Committees.
• Manage site activation readiness, timeliness, and quality while mitigating potential risks.
• Interact with regulatory bodies (CA/EC) and handle official responses.
• Customize Patient Information Sheets and Informed Consent Forms for specific sites.
• Maintain project trackers and ensure TMF (Trial Master File) audit readiness.
• Collaborate with CRAs and Site Contract Management for budget and contract execution.

Requirements

• Bachelor’s degree in life sciences, healthcare, or Registered Nurse (RN) qualification.
• Minimum 1 year of experience as a Regulatory or Start Up specialist in a CRO or pharmaceutical/biotech industry.
• Fluency in English is required.
• Strong organizational and communication skills.
• Proficiency in computerized information systems and electronic spreadsheets.

Nice to have

• Qualification or work experience as a Pharmacist.
• Advanced degree (MD, PhD, PharmD) or RAC certification.
• Experience with milestone tracking tools.

Culture & Benefits

• Work in a growing organization focused on groundbreaking cancer therapies.
• Culture that values employee input and nurtures new ideas.
• Commitment to diversity, equity, and inclusion as an Equal Opportunity Employer.