Regulatory and Site Start Up Specialist (Medical)

TL;DR

Regulatory and Site Start Up Specialist (Medical): Managing clinical trial submissions and site activation processes with an accent on regulatory compliance and essential document management. Focus on coordinating with Competent Authorities and Ethics Committees to ensure timely site readiness and compliance with ICH-GCP guidelines.

Location: Remote, China

Company

hirify.global is a CRO that integrates clinical trial execution with deep scientific knowledge, specializing in Oncology and Rare Disease.

What you will do

• Manage the delivery and quality of site activation readiness within assigned sites, mitigating potential risks.
• Prepare and submit Clinical Trial Application forms and dossiers to Competent Authorities and Ethics Committees.
• Review and adapt Informed Consent Forms and manage the collection of essential documents for site activation.
• Act as a Subject Matter Expert (SME) for in-country members regarding site start-up activities.
• Collaborate with CRAs and Site Contract Management to facilitate budget and contract negotiations.
• Maintain regulatory intelligence tools and project trackers to ensure compliance with local and international laws.

Requirements

• Bachelor’s degree in life sciences, healthcare, or equivalent combination of education and experience.
• 1+ year of experience as a Regulatory or Start Up specialist in a CRO or pharmaceutical/biotech industry.
• Fluency in English and Chinese is required.
• Must be based in China.
• Strong organizational and communication skills.

Nice to have

• Advanced degree (MD, PhD, PharmD), RAC certification, or Masters in Regulatory Science.
• Experience using milestone tracking tools and systems.
• Deep regulatory and site start-up experience specific to the local market.

Culture & Benefits

• Opportunity to work on life-changing therapies in Oncology and Rare Disease.
• Fully remote work arrangement within China.
• Inclusive work environment as an Equal Opportunity Employer.